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The NCCN Guidelines for Survivorship include recommendations for screening, evaluation, and treatment of psychosocial and physical problems resulting from adult-onset cancer and its treatment. They also include recommendations to promote healthy behaviors and immunizations in survivors and provide a framework for care coordination. These NCCN Guidelines Insights summarize the panel's current recommendations regarding sexual health and fertility.

Background: Spirituality is an important domain of well-being for cancer survivors, yet we know little about the different trajectories of survivors' spiritual well-being across the transition from active treatment to survivorship. Further, the specific psychosocial resources and coping efforts that might predict distinct trajectories of spiritual well-being have yet to be identified., Aims: In this study, we characterized trajectories of survivors' spiritual well-being (peace, meaning, faith) across the first year of survivorship and examined whether social support and coping strategies predicted these trajectories., Methods: Participants (N = 482) completed five surveys over the course of a year following a diagnosis of breast (63.5%), prostate (25.7%), or colorectal cancer (10.8%). We used latent class linear mixed modeling to identify spiritual well-being trajectory classes (FACIT-Sp) and employed multinomial logistic regression models to examine whether social support and specific coping styles predicted class membership., Results: While the majority of our sample had moderate levels of spiritual well-being, over one-third reported very low levels of peace. Distinct latent classes for peace (four classes), meaning (five classes), and faith (five classes) were identified among adult cancer survivors transitioning from treatment to survivorship. Higher social support and adaptive coping predicted greater likelihood of belonging to classes that maintained higher levels of peace, meaning, and faith following cancer treatment., Conclusions: Cancer survivors show unique trajectories of spiritual well-being as they transition from active treatment to survivorship. Social support and coping may be important resources for maintaining spiritual well-being during this critical transition period., (© 2024 John Wiley & Sons Ltd.)

Among the goals of patient-centric care are the advancement of effective personalized treatment, while minimizing toxicity. The phase 2 I-SPY2.2 trial uses a neoadjuvant sequential therapy approach in breast cancer to further these goals, testing promising new agents while optimizing individual outcomes. Here we tested datopotamab-deruxtecan (Dato-DXd) in the I-SPY2.2 trial for patients with high-risk stage 2/3 breast cancer. I-SPY2.2 uses a sequential multiple assignment randomization trial design that includes three sequential blocks of biologically targeted neoadjuvant treatment: the experimental agent(s) (block A), a taxane-based regimen tailored to the tumor subtype (block B) and doxorubicin-cyclophosphamide (block C). Patients are randomized into arms consisting of different investigational block A treatments. Algorithms based on magnetic resonance imaging and core biopsy guide treatment redirection after each block, including the option of early surgical resection in patients predicted to have a high likelihood of pathological complete response, the primary endpoint. There are two primary efficacy analyses: after block A and across all blocks for the six prespecified breast cancer subtypes (defined by clinical hormone receptor/human epidermal growth factor receptor 2 (HER2) status and/or the response-predictive subtypes). We report results of 103 patients treated with Dato-DXd. While Dato-DXd did not meet the prespecified threshold for success (graduation) after block A in any subtype, the treatment strategy across all blocks graduated in the hormone receptor-negative HER2 - Immune - DNA repair deficiency - subtype with an estimated pathological complete response rate of 41%. No new toxicities were observed, with stomatitis and ocular events occurring at low grades. Dato-DXd was particularly active in the hormone receptor-negative/HER2 - Immune - DNA repair deficiency - signature, warranting further investigation, and was safe in other subtypes in patients who followed the treatment strategy. ClinicalTrials.gov registration: NCT01042379 ., Competing Interests: Competing interests: J.L.M. reports institutional research funding from AstraZeneca, Seagen, Sermonix and Olema and advisory and consulting roles with Pfizer, Seagen, Sermonix, Novartis, Stemline, AstraZeneca, Olema, GlaxoSmithKline and GE Healthcare. C.Y. reports institutional research grant from NCI/NIH; salary support and travel reimbursement from QLHC; a United States patent titled ‘Breast cancer response prediction subtypes’ (no. 18/174,491); and University of California Inventor Share. H.S.R. reports institutional research support from AstraZeneca, Daiichi Sankyo, Inc., F. Hoffmann–La Roche AG/Genentech, Inc., Gilead Sciences, Inc., Lilly; Merck and Co., Novartis Pharmaceuticals Corporation, Pfizer, Stemline Therapeutics, OBI Pharma, Ambrx, Greenwich Pharma; and advisory and consulting roles with Chugai, Puma, Sanofi, Napo and Mylan. R.N. reports research funding from Arvinas, AstraZeneca, BMS, Corcept Therapeutics, Genentech/Roche, Gilead, GSK, Merck, Novartis, OBI Pharma, OncoSec, Pfizer, Relay, Seattle Genetics, Sun Pharma and Taiho and advisory roles with AstraZeneca, BeyondSpring, Daiichi Sankyo, Exact Sciences, Fujifilm, GE, Gilead, Guardant Health, Infinity, iTeos, Merck, Moderna, Novartis, OBI, OncoSec, Pfizer, Sanofi, Seagen and Stemline. M.D. reports research grants from NIH/NCI and NIH/NIA, and contracts from PCORI. A.J.C. reports institutional research funding from Merck, Amgen, Puma, Seagen, Pfizer and Olema and advisory roles with AstraZeneca and Genentech. A.Z. reports institutional research funding from Merck, honoraria for Medscape and participation on Pfizer Advisory Board. A.S.C. reports institutional research funding from Novartis and Lilly. A.D.E. reports support from Scorpion, Infinity and Deciphera. E.S.-R. reports grants from V Foundation, NIH, Susan G. Komen; institutional research funding from GSK, Seagen, Pfizer, Lilly; consulting and honoraria from Novartis, Merck, Seagen, AstraZeneca, Lilly; Cancer Awareness Network Board member and support from ASCO and NCCN. J.C.B. reports institutional research funding from Eli Lilly and SymBioSis, participation on the Data Safety Monitoring Committee of Cairn Surgical and honoraria from PER, PeerView, OncLive, EndoMag and UpToDate. C.V. reports institutional research funding from Pfizer, Seagen, H3 Biomedicine/Eisai, AstraZeneca, CytomX; research funding to previous institution from Genentech, Roche, Pfizer, Incyte, Pharmacyclics, Novartis, TRACON Pharmaceuticals, Innocrin Pharmaceuticals, Zymeworks and H3 Biomedicine; advisory and consulting roles with Guidepoint, Novartis, Seagen, Daiichi Sankyo, AstraZeneca and Cardinal Health; unpaid consulting with Genentech; and participation in non-CME activity with Gilead, AstraZeneca. C.O. reports consulting fees from AstraZeneca, Guardant Health and Jazz Pharmaceuticals. K.S.A. reports institutional research funding from AstraZeneca, Daiichi Sankyo, Seattle Genetics and QLHC; Independent Data and Safety Monitoring committee at Seattle Genetics. K.M.K. reports advisory and consultant roles for Eli Lilly, Pfizer, Novartis, AstraZeneca, Daiichi Sankyo, Puma, 4D Pharma, OncoSec, Immunomedics, Merck, Seagen, Mersana, Menarini Silicon Biosystems, Myovant, Takeda, Biotheranostics, Regor, Gilead, Prelude Therapeutics, RayzeBio, eFFECTOR Therapeutics and Cullinan Oncology; and reports institutional research funding from Genentech/Roche, Novartis, Eli Lilly, AstraZeneca, Daiichi Sankyo and Ascentage. C.I. reports institutional research funding from Tesaro/GSK, Seattle Genetics, Pfizer, AstraZeneca, BMS, Genentech, Novartis and Regeneron; consultancy roles with AstraZeneca, Genentech, Gilead, ION, Merck, Medscape, MJH Holdings, Novartis, Pfizer, Puma and Seagen; and royalties from Wolters Kluwer (UptoDate) and McGraw Hill (Goodman and Gillman). J.T. serves as institutional principal investigator for clinical trial with Intuitive Surgical; editor lead for ABS, CGSO, SCORE, Breast Education Committee Track Leader, ASCO SESAP 19 and Breast Co-Chair, ACS. A.T. owns stock at Johnson and Johnsons, Gilead, Bristol Myers Squibb, reports participation on Pfizer Advisory Board: AstraZeneca and reports institutional research funding from Merck and Sanofi and royalties from UptoDate. R.B. reports a consultancy role at Genentech and stock ownership at Cerus Corp. K.Y. received research support unrelated to this work and paid to the institution from Pfizer, Gilead, Seagen, Dantari Pharmaceuticals, Treadwell Therapeutics, and Relay Therapeutics; support from American Cancer Society IRG grant no. IRG-19-230-48-IRG, UC San Diego Moores Cancer Center, Specialized Cancer Center support grant NIH/NCI P30CA023100, Curebound Discovery Award (2023, 2024). T.S. reports honoraria from Hologic. L.P. reports institutional research funding from Susan Komen Foundation, Breast Cancer Research Foundation, NCI, Pfizer, AstraZeneca, Menarini/Stemline, Bristol Myers Squibb, Merck and Co.; consulting fees from AstraZeneca, Merck, Novartis, Genentech, Natera, Personalis, Exact Sciences and Stemline/Menarini; patent titled ‘Method of measuring residual cancer and predicting patient survival’ (no. 7711494); and Data and Safety Monitoring Board member of the DYNASTY Breast02, OPTIMA and PARTNER trials. M.S.T. reports institutional research funding from Lilly, Gilead Sciences, Phoenix Molecular Designs, AstraZeneca, Regeneron, Merck and Novartis. A.L.A., P.B. and P.N. are employees of QLHC. G.L.H. reports institutional research grant from NIH (1R01CA255442). W.F.S. reports shares of IONIS Pharmaceuticals and Eiger Biopharmaceuticals, received consulting fees from AstraZeneca, is a cofounder with equity in Delphi Diagnostics and issued patents for (1) a method to calculate residual cancer burden and (2) genomic signature to measure sensitivity to endocrine therapy. J.P. reports honoraria from Methods in Clinical Research—faculty SCION workshop; support from ASCO and advocate scholarship; AACR—SSP program; VIVLI, U Wisc SPORE—EAB, QuantumLEAD—COVID DSMB, PCORI—reviewer and I-SPY advocate lead. P.P. reports institutional research funding from Genentech/Roche, Fabre-Kramer, Advanced Cancer Therapeutics, Caris Centers of Excellence, Pfizer, Pieris Pharmaceuticals, Cascadian Therapeutics, Bolt, Byondis, Seagen, Orum Therapeutics and Carisma Therapeutics; consulting fees from Personalized Cancer Therapy, OncoPlex Diagnostics, Immunonet BioSciences, Pfizer, HERON, Puma Biotechnology, Sirtex, CARIS Life sciences, Juniper, Bolt Biotherapeutics and AbbVie; honoraria from DAVA Oncology, OncLive/MJH Life Sciences, Frontiers—publisher, SABCS and ASCO; Speakers’ Bureau: Genentech/Roche (past); United States patent no. 8486413, United States patent no. 8501417, United States patent no. 9023362, United States patent no. 9745377; uncompensated roles with Pfizer, Seagen and Jazz. R.A.S. reports institutional research funding from OBI Pharma, QLHC, AstraZeneca and Gilead, serves on AstraZeneca and Stemline Advisory Boards and Gilead Speaker’s Bureau and reports consultancy role with QLHC. A.D. reports institutional research funding from Novartis, Pfizer, Genentech and NeoGenomics; Program Chair, Scientific Advisory Committee, ASCO. D.Y. reports research funding from NIH/NCI P30 CA 077598, P01 CA234228-01 and R01CA251600, consulting fees from Martell Diagnostics, and honoraria and travel for speaking at the ‘International Breast Cancer Conference.’ L.J.v.V. is a founding advisor and shareholder of Exai Bio and is a part-time employee and owns stock in Agendia. N.M.H. reports institutional research funding from NIH. L.J.E. reports funding from Merck and Co., participation on an advisory board for Blue Cross Blue Shield and personal fees from UpToDate and is an unpaid board member of QLHC. The other authors declare no competing interests., (© 2024. The Author(s), under exclusive licence to Springer Nature America, Inc.)

Sequential adaptive trial designs can help accomplish the goals of personalized medicine, optimizing outcomes and avoiding unnecessary toxicity. Here we describe the results of incorporating a promising antibody-drug conjugate, datopotamab-deruxtecan (Dato-DXd) in combination with programmed cell death-ligand 1 inhibitor, durvalumab, as the first sequence of therapy in the I-SPY2.2 phase 2 neoadjuvant sequential multiple assignment randomization trial for high-risk stage 2/3 breast cancer. The trial includes three blocks of treatment, with initial randomization to different experimental agent(s) (block A), followed by a taxane-based regimen tailored to tumor subtype (block B), followed by doxorubicin-cyclophosphamide (block C). Subtype-specific algorithms based on magnetic resonance imaging volume change and core biopsy guide treatment redirection after each block, including the option of early surgical resection in patients predicted to have a high likelihood of pathologic complete response, which is the primary endpoint assessed when resection occurs. There are two primary efficacy analyses: after block A and across all blocks for six prespecified HER2-negative subtypes (defined by hormone receptor status and/or response-predictive subtypes). In total, 106 patients were treated with Dato-DXd/durvalumab in block A. In the immune-positive subtype, Dato-DXd/durvalumab exceeded the prespecified threshold for success (graduated) after block A; and across all blocks, pathologic complete response rates were equivalent to the rate expected for the standard of care (79%), but 54% achieved that result after Dato-DXd/durvalumab alone (block A) and 92% without doxorubicin-cyclophosphamide (after blocks A + B). The treatment strategy across all blocks graduated in the hormone-negative/immune-negative subtype. No new toxicities were observed. Stomatitis was the most common side effect in block A. No patients receiving block A treatment alone had adrenal insufficiency. Dato-DXd/durvalumab is a promising therapy combination that can eliminate standard chemotherapy in many patients, particularly the immune-positive subtype.ClinicalTrials.gov registration: NCT01042379 ., Competing Interests: Competing interests: R.A.S. reports institutional research funding from OBI Pharma, QLHC, AstraZeneca and Gilead; serves on AstraZeneca and Stemline Advisory Boards and Gilead Speaker’s Bureau; and has a consultancy role with QLHC. M.S.T. reports institutional research funding from Lilly, Gilead Sciences, Phoenix Molecular Designs, AstraZeneca, Regeneron, Merck and Novartis. C.Y. reports institutional research grant from NCI/NIH; salary support and travel reimbursement from QLHC; US patent titled, ‘Breast cancer response prediction subtypes’ (no. 18/174,491); and University of California Inventor Share. R.N. reports research funding from Arvinas, AstraZeneca, BMS, Corcept Therapeutics, Genentech/Roche, Gilead, GSK, Merck, Novartis, OBI Pharma, OncoSec, Pfizer, Relay, Seattle Genetics, Sun Pharma and Taiho Oncology and advisory roles with AstraZeneca, BeyondSpring, Daiichi Sankyo, Exact Sciences, Fujifilm, GE, Gilead, Guardant Health, Infinity, iTeos, Merck, Moderna, Novartis, OBI, OncoSec, Pfizer, Sanofi, Seagen and Stemline. H.S.R. reports institutional research support from AstraZeneca, Daiichi Sankyo, F. Hoffmann-La Roche AG/Genentech, Gilead Sciences, Lilly, Merck & Co., Novartis Pharmaceuticals Corporation, Pfizer, Stemline Therapeutics, OBI Pharma, Ambrx and Greenwich Pharma and has advisory and consulting roles with Chugai, Puma, Sanofi, Napo and Mylan. M.D. reports research grants from NIH/NCI and NIH/NIA, and contracts from PCORI. A.J.C. reports institutional research funding from Merck, Amgen, Puma, Seagen, Pfizer and Olema and has advisory roles with AstraZeneca and Genentech. E.S.-R. reports grants from V Foundation, NIH and Susan G. Komen; institutional research funding from GSK, Seagen, Pfizer and Lilly; and consulting and honoraria from Novartis, Merck, Seagen, AstraZeneca and Lilly; is a Cancer Awareness Network Board member and receives support from ASCO and NCCN. J.C.B. reports institutional research funding from Eli Lilly and SymBioSis, participation on the Data Safety Monitoring Committee of Cairn Surgical and honoraria from PER, PeerView, OncLive, EndoMag and UpToDate. C.O. reports consulting fees from AstraZeneca, Guardant Health and Jazz Pharmaceuticals. K.K. reports advisory and consultant roles for Eli Lilly, Pfizer, Novartis, AstraZeneca, Daiichi Sankyo, Puma, 4D Pharma, OncoSec, Immunomedics, Merck, Seagen, Mersana, Menarini Silicon Biosystems, Myovant, Takeda, Biotheranostics, Regor, Gilead, Prelude Therapeutics, RayzeBio, eFFECTOR Therapeutics and Cullinan Oncology and reports institutional research funding from Genentech/Roche, Novartis, Eli Lilly, AstraZeneca, Daiichi Sankyo and Ascentage. A.D.E. reports support from Scorpion, Infinity and Deciphera. C.V. reports institutional research funding from Pfizer, Seagen, H3 Biomedicine/Eisai, AstraZeneca and CytomX; research funding to their previous institution from Genentech, Roche, Pfizer, Incyte, Pharmacyclics, Novartis, TRACON Pharmaceuticals, Innocrin Pharmaceuticals, Zymeworks and H3 Biomedicine; advisory and consulting roles with Guidepoint, Novartis, Seagen, Daiichi Sankyo, AstraZeneca and Cardinal Health; unpaid consulting with Genentech; and participation in non-CME activity with Gilead and AstraZeneca. N.W. reports participation on Gilead’s Advisory Board and honoraria from OncLive, NCCN and Total Health Conferencing. K.S.A. reports institutional research funding from AstraZeneca, Daiichi Sankyo, Seattle Genetics, QLHC and the IDSM committee at Seattle Genetics. A.S.C. reports institutional research funding from Novartis and Lilly. C.F. reports honoraria from Curio Science and OncLive and institutional research funding from Eli Lily. C.I. reports institutional research funding from Tesaro/GSK, Seattle Genetics, Pfizer, AstraZeneca, BMS, Genentech, Novartis and Regeneron; consultancy roles with AstraZeneca, Genentech, Gilead, ION, Merck, Medscape, MJH Holdings, Novartis, Pfizer, Puma and Seagen; and royalties from Wolters Kluwer (UpToDate) and McGraw Hill (Goodman and Gilman). A.T. owns stock at Johnson & Johnson, Gilead, Bristol Myers Squibb; reports participation on Pfizer’s Advisory Board: AstraZeneca; reports institutional research funding from Merck and Sanofi; and has royalties from UpToDate. J.T. serves as institutional principal investigator for clinical trial with Intuitive Surgical and is the Editor Lead for ABS, CGSO, SCORE, Breast Education Committee Track Leader, ASCO SESAP 19 and Breast Co-Chair, ACS. K.Y. received research support unrelated to this work and paid to the institution from Pfizer, Gilead, Seagen, Dantari Pharmaceuticals, Treadwell Therapeutics and Relay Therapeutics and support from American Cancer Society IRG grant (no. IRG-19-230-48-IRG), UC San Diego Moores Cancer Center, Specialized Cancer Center support grant NIH/NCI (P30CA023100) and Curebound Discovery Award (2023, 2024). L.H. reports advisory and consultancy roles with Pfizer, and AstraZeneca. K.G. reports participation in advisory boards with honoraria to the institution from AstraZeneca, Novartis, Puma Biotechnologies, Eli Lilly, Gilead, Exact Sciences, NeoGenomics and TerSera Therapeutics. F.M.H. reports consultancy for Novartis. T.S. reports honoraria from Hologic. A.L.A., P.B. and P.N. are employees of QLHC. G.L.H. reports an institutional research grant from NIH (1R01CA255442). W.F.S. reports shares in IONIS Pharmaceuticals and Eiger Biopharmaceuticals; received consulting fees from AstraZeneca; is a cofounder with equity in Delphi Diagnostics; and issued patents for: (1) a method to calculate residual cancer burden, and (2) genomic signature to measure sensitivity to endocrine therapy. J.P. reports honoraria from Methods in Clinical Research (Faculty SCION Workshop) and support from ASCO and Advocate Scholarship; AACR (SSP Program); and VIVLI, U Wisc SPORE (EAB), QuantumLEAD (COVID DSMB), PCORI; is a reviewer; and is an I-SPY advocate lead. P.P. reports institutional research funding from Genentech/Roche, Fabre-Kramer, Advanced Cancer Therapeutics, Caris Centers of Excellence, Pfizer, Pieris Pharmaceuticals, Cascadian Therapeutics, Bolt, Byondis, Seagen, Orum Therapeutics and Carisma Therapeutics; consulting fees from Personalized Cancer Therapy, OncoPlex Diagnostics, Immunonet BioSciences, Pfizer, HERON, Puma Biotechnology, Sirtex, Caris Life Sciences, Juniper, Bolt Biotherapeutics and AbbVie; honoraria from Dava Oncology, OncLive/MJH Life Sciences, Frontiers (Publisher), SABCS and ASCO; Speakers’ Bureau: Genentech/Roche (past); and US patent no. 8,486,413, US patent no. 8,501,417, US patent no. 9,023,362 and US patent no. 9,745,377; and uncompensated roles with Pfizer, Seagen and Jazz. A.D.M. reports institutional research funding from Novartis, Pfizer, Genentech and NeoGenomics and is a program chair of the Scientific Advisory Committee, ASCO. D.Y. reports research funding from NIH/NCI: P30CA 077598, P01CA234228-01 and R01CA251600; consulting fees from Martell Diagnostics; and honoraria and travel for speaking at the ‘International Breast Cancer Conference’. L.J.v.V. is a founding advisor and shareholder of Exai Bio and is a part-time employee and owns stock in Agendia. N.M.H. reports institutional research funding from NIH. L.J.E. reports funding from Merck & Co., participation on an advisory board for Blue Cross Blue Shield, and personal fees from UpToDate and is an unpaid board member of QLHC. All other authors declare no competing interests., (© 2024. The Author(s), under exclusive licence to Springer Nature America, Inc.)

Following treatment, cancer survivors often experience pain that negatively impacts their quality of life. Although both anxiety and fear of cancer recurrence (FCR) have been shown to exacerbate pain interference, less is known about either the temporal relationship between anxiety/FCR and pain interference or modifiable cognitive/emotional factors that might moderate that relationship among cancer survivors. This longitudinal study aims to advance our understanding of the impact of both anxiety and FCR following primary cancer treatment on subsequent pain interference. We also examined potentially modifiable moderators (i.e., cancer-related illness beliefs and emotion regulation difficulties) of the relationship between anxiety/FCR and subsequent pain interference. Adults (N = 397; 67% female; M age = 59.1 years) diagnosed with breast, colorectal, or prostate cancer completed self-report measures at baseline (average of 2.5 months following treatment completion) and at 6-month follow-up. Both greater anxiety and FCR not only predicted subsequent pain interference, but also predicted increases in pain interference over time. Additionally, complex interaction patterns were observed between anxiety and the potential moderators on pain interference. Specifically, lower Personal Control beliefs and higher Consequences beliefs were associated with greater pain interference for those with lower levels of anxiety/FCR. Emotion regulation difficulties also moderated the anxiety-pain interference link (i.e., was more strongly associated with greater pain interference at lower levels of anxiety), but not the FCR-pain link. Chronicity beliefs did not interact with anxiety or FCR in predicting pain interference. This study advances our understanding of the role of anxiety/FCR on pain interference over time as well as potential psychological treatment targets for individuals at greater risk for longer-term pain following cancer treatment., (© 2024. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Purpose: To investigate participant characteristics associated with clinically meaningful weight loss (≥ 5% weight loss) among breast cancer survivors participating in the Lifestyle, Exercise, and Nutrition (LEAN) study., Methods: Female breast cancer survivors with a body mass index ≥ 25 kg/m 2 were enrolled in a 6-month weight loss intervention. Univariate and multivariable logistic regression were used to determine baseline predictors of clinically meaningful weight loss (< vs. ≥ 5%) among those in the intervention arm. The area under the receiver operator characteristic curve (ROC-AUC) C-statistic evaluated the final model's ability to classify weight loss success., Results: Baseline data were available for 77 participants. Having a history of weight gain during breast cancer treatment was associated with lower odds of achieving ≥ 5% weight loss (OR = 0.36, 95% CI 0.13 - 0.99) compared to women with no history of weight gain during cancer treatment., Conclusion: Breast cancer survivors with overweight or obesity who gained weight during their cancer treatment were less likely to achieve clinically meaningful weight loss during a post-treatment weight loss intervention., Implication for Cancer Survivors: Breast cancer survivors are encouraged to achieve and maintain a healthy body weight to minimize the risk for cancer recurrence and comorbidity. Our results indicate that programs aimed at prevention of weight gain during treatment could aid in this goal. Understanding characteristics that increase or decrease the likelihood of achieving clinically meaningful weight loss will inform the design of programs that better support breast cancer survivors' weight loss success., Competing Interests: Declarations Ethics approval The study was conducted according to the guidelines of the Declaration of Helsinki and approved by the Institutional Review Board (or Ethics Committee) of Yale School of Medicine. Consent to participate Informed consent was obtained from all subjects involved in the study. Conflict of interest Financial Interests: Brenda Cartmel significant other Pfizer stock. Tara Sanft paid speaker for Hologic. Transparency statement LEAN1 (NCT02109068) and LEAN2 (NCT02110641) were both pre-registered at clinicaltrials.gov. The analysis plan was not formally pre-registered., (© 2024. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Purpose: Use qualitative and quantitative methods to explore factors influencing the adoption of guideline-based physical activity (PA) and dietary recommendations among participants enrolled in a lifestyle intervention during and after chemotherapy for breast cancer., Methods: Among women with stage I-III breast cancer who participated in the intervention arm of the Lifestyle, Exercise, and Nutrition early after diagnosis (LEANer) trial, we used stratified, purposeful sampling to interview women who met both, one, or neither intervention goal after the 1-year intervention: (1) 150 min/week moderate-to-vigorous intensity exercise via a self-reported PA questionnaire and (2) improved self-reported diet quality measured by the Healthy Eating Index-2015. Semi-structured interviews were audio-recorded, transcribed verbatim, and analyzed using thematic content analysis., Results: The 29 women interviewed were 52 ± 11 years old on average, with a mean body mass index of 29.6 ± 7.7 kg/m 2 . Three themes emerged regarding aspects of the LEANer intervention that facilitated behavior change: (1) providing a conduit of trustworthy, timely, and personalized support and education; (2) shifting mindsets and enhanced understanding of the benefits of PA and nutrition during chemotherapy; and (3) fostering a sense of control and alternative focus. Factors described as hindering adoption of goals included: (1) adverse effects of chemotherapy and (2) competing priorities., Conclusions: Women reported the external support, tailored education, and experiencing the physical and mental benefits of the LEANer intervention facilitated the adoption of the interventions' behavioral goals. Addressing chemotherapy-related symptoms and competing priorities may facilitate adherence to lifestyle interventions during chemotherapy for breast cancer., (© 2024. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Chemotherapy treatment-related side-effects are common and increase the risk of suboptimal outcomes. Exercise interventions during cancer treatment improve self-reported physical functioning, fatigue, anxiety, and depression, but it is unclear whether these interventions improve important clinical outcomes, such as chemotherapy relative dose intensity (RDI). The National Cancer Institute funded the Exercise and Nutrition to Improve Cancer Treatment-Related Outcomes (ENICTO) Consortium, to address this knowledge gap. This paper describes the mechanisms hypothesized to underpin intervention effects on clinically-relevant treatment outcomes, briefly outlines each project's distinct research aims, summarizes the scope and organizational structure of ENICTO, and provides an overview of the integrated common data elements used to pursue research questions collectively. In addition, the paper includes a description of consortium-wide activities and broader research community opportunities for collaborative research. Findings from the ENICTO Consortium have the potential to accelerate a paradigm shift in oncology care such that cancer patients could receive exercise and nutrition programming as the standard of care in tandem with chemotherapy to improve RDI for a curative outcome., (© The Author(s) 2024. Published by Oxford University Press.)

Background: Little is known about improving physical activity (PA) and diet during and after chemotherapy for breast cancer. This secondary analysis examines changes in PA and diet quality during a yearlong intervention for patients with breast cancer undergoing chemotherapy and evaluates factors associated with these changes., Methods: Newly diagnosed patients with breast cancer (N = 173) undergoing chemotherapy were randomized to a year-long nutrition and exercise intervention (n = 87) or usual care (UC, n = 86). Mixed models compared 1-year changes in PA and diet quality via the Healthy Eating Index (HEI)-2015 by study arm. Among the intervention group, baseline factors associated with change in PA and diet were assessed with multivariable linear and logistic regression., Results: At 1 year, compared with UC, the intervention arm increased PA more (mean difference = 136.1 minutes/week; 95% CI, 90.2-182.0), participated in more strength training (56% vs. 15%; p < .001), and had suggestive improvements in HEI-2015 (mean difference = 2.5; 95% CI, -0.3 to 5.3; p = .08). In the intervention arm, lower fatigue was associated with improved PA (p = .04) and higher education was associated with improved HEI-2015 (p = .001) at 1 year. Higher HEI-2015 (p = .04) and married/living with someone (p = .05) were associated with higher odds of participating in strength training at 1 year., Conclusions: This year-long lifestyle intervention for patients with breast cancer undergoing chemotherapy resulted in increases in PA and suggestive improvements in diet quality. Behavior change was associated with baseline fatigue, diet quality, education, and married/living with someone. Addressing these factors in interventions may improve uptake of lifestyle behaviors in trials during and after chemotherapy., (© 2024 American Cancer Society.)

Sleep disturbance is common among women with breast cancer and is associated with greater symptom distress and poorer outcomes. Yet, for the unique subgroup of young women with breast cancer (YWBC), there is limited information on sleep. To address the gap in our understanding of sleep health in YWBC, we explored their perspective on sleep quality, sleep changes over time, contributing factors, and any strategies used to promote sleep. As part of an explanatory sequential mixed method study, we recruited a sub-sample of 35 YWBC (≤ 50 years of age at the time of diagnosis) from the larger quantitative study phase. These participants were within the first 5 years since diagnosis and completed primary and systemic adjuvant therapy. We conducted virtual semi-structured interviews, transcribed them verbatim, and analyzed data with an interpretive description approach. YWBC experience difficulty falling asleep, waking up at night, and not feeling refreshed in the morning. They attributed interrupted sleep to vasomotor symptoms, anxiety/worry, ruminating thoughts, everyday life stressors, and discomfort. The sleep disturbance was most severe during and immediately after treatment but persisted across the 5 years of survivorship. The participants reported trying pharmacologic and non-pharmacologic strategies to improve the quantity and quality of their sleep. Future research would benefit from longitudinal designs to capture temporal changes in sleep and develop interventions to improve sleep health. Clinically, assessment of sleep health is indicated for YWBC related to the prevalence of disturbed sleep. IMPLICATIONS FOR CANCER SURVIVORS: Early access to sleep assessment and management, ideally before cancer treatment, would be beneficial for young breast cancer survivors. In addition, cancer treatment plans should include physical and psychological symptoms, especially those reported by women in this study: vasomotor symptoms, anxiety and worry, discomfort, and pain., (© 2023. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Introduction: Military veterans are at increased risk of substance use disorders. Limited research is available about veterans' cannabis use (CU) during the coronavirus disease 2019 (COVID-19) pandemic. This study estimated the prevalence of past 30-day CU, investigated individual-level correlates of past 30-day CU, and evaluated the reasons (medical, recreational, or both) of past 30-day CU among U.S. Veterans during the second wave of the COVID-19 pandemic., Materials and Methods: We used population-based, cross-sectional data from the 2021 Behavioral Risk Factor Surveillance System Survey Marijuana Use model. The sample included nationally representative military veterans aged 18+ years (n = 11,167). The outcome was past 30-day CU. Individual-level demographic, socioeconomic, behavioral, and clinical correlates were examined. Analyses were weighted to account for the survey's complex design with results generalizable to nearly 2.9 million veterans. We conducted weighted descriptive statistics, prevalence estimates, and multivariable logistic regression analyses., Results: Out of 2.9 million veterans, 11.1% self-reported as non-Hispanic Black, 3.7% Hispanic, and 79.1% non-Hispanic White; 88.5% were men, and 72.8% were aged 50+ years. About 14.6% were current tobacco smokers, 4.7% were current e-cigarette users, 12.5% were binge alcohol drinkers, and 43.4% had three or more comorbid conditions. Overall, 8.5% reported CU in the past 30 days, of which 30.4% used it for medical reasons and 25.8% used it for nonmedical reasons. The prevalence of past 30-day CU decreased with age, education, and income level. Compared to their counterparts, the odds of past 30-day CU were greater among men, those living in urban areas, those with frequent mental distress, infrequent physical distress, and those who had at least one comorbid condition. Non-Hispanic Black veterans had 89% increased odds of past 30-day CU (adjusted odds ratio [AOR] =1.89, 95% confidence interval [CI], 1.19-3.0) compared with non-Hispanic White veterans. Current tobacco smokers had 3.54 (95% CI, 2.40-5.24) and former smokers had 1.78 (95% CI, 1.28-2.47) times higher odds of reporting past 30-day CU than never smokers. Current e-cigarette use (AOR = 3.37, 95% CI, 2.20-5.16) and binge drinking (AOR = 3.18, 95% CI, 2.29-4.41) were also statistically significantly associated with increased odds of past 30-day CU compared to no e-cigarette use and no binge drinking., Conclusions: CU is prevalent among veterans, and certain subgroups are at higher risk of CU. Thus, identifying high-risk subgroups of veterans and adequately educating them about CU's benefits, risks, and safety is crucial., (Published by Oxford University Press on behalf of the Association of Military Surgeons of the United States 2023. This work is written by (a) US Government employee(s) and is in the public domain in the US.)

Purpose: To prospectively examine different trajectories of recovery, across different aspects of physical health and function and to examine trajectory class membership., Methods: This prospective study enrolled 569 recently diagnosed adult cancer patients (Mage = 58.7) between 2019 and 2022 identified through the Rapid Case Ascertainment resource of The Yale Cancer Center. Patients were diagnosed with breast (63.8%), prostate (25.3%), or colorectal cancer (10.9%) within six-months of baseline assessment. Participants completed comprehensive psychosocial and health survey measures (SF-12) through REDCap at five time points. Growth mixture modeling examined unconditional distinct trajectories for four aspects of physical health and function. We fit logistic regression and multinomial logistic regression models to estimate associations between psychosocial predictors of trajectory class membership for each of the four aspects., Results: We identified distinct trajectories of physical health and function. Over one-third (38.4%) of the sample experienced low and declining scores in their ability to accomplish work/regular daily activities due to physical health. Over half (54.9%) demonstrate moderately stable general health with no improvement over time. A small but significant subset of the sample (3%, 5.7%, 5%) was in the moderate and declining groups with sharp decline in physical function, bodily pain, and general health, after treatment. Different predictors of trajectory class membership were also found., Conclusions: Our results showed heterogeneity in physical health and function trajectories and different patterns of predictors for each aspect of physical health and function. Findings have the potential to inform screening and intervention efforts to help those who may need additional support., (© 2024. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Weight gain after breast cancer diagnosis is associated with adverse health outcomes. Yet, few studies have characterized post-diagnosis weight change in the modern treatment era or populations most at risk for weight changes. Among women diagnosed with stages I-III breast cancer in the Smilow Care Network (2013-2019; N = 5441), we abstracted demographic and clinical characteristics from electronic health records and survival data from tumor registries. We assessed if baseline characteristics modified weight trajectories with nonlinear multilevel mixed-effect models. We evaluated body mass index (BMI) at diagnosis and weight change 1-year post-diagnosis in relation to all-cause and breast cancer-specific mortality with Cox proportional hazard models. Women had 34.4 ± 25.5 weight measurements over 3.2 ± 1.8 years of follow-up. Weight gain was associated with ER/PR-, HER2+ tumors, BMI ≤ 18.5 kg/m 2 , and age ≤ 45 years (+4.90 kg (standard error [SE] = 0.59), +3.24 kg (SE = 0.34), and +1.75 kg (SE = 0.10), respectively). Weight loss was associated with BMI ≥ 35 kg/m 2 and age ≥ 70 years (-4.50 kg (SE = 0.08) and -4.34 kg (SE = 0.08), respectively). Large weight loss (≥10%), moderate weight loss (5-10%), and moderate weight gain (5-10%) 1-year after diagnosis were associated with higher all-cause mortality (hazard ratio [HR] = 2.93, 95% confidence interval [CI] = 2.28-3.75, HR = 1.32, 95% CI = 1.02-1.70 and HR = 1.39, 95% CI = 1.04-1.85, respectively). BMI ≥ 35 kg/m 2 or BMI ≤ 18.5 kg/m 2 at diagnosis were also associated with higher all-cause mortality. Weight change after a breast cancer diagnosis differed by demographic and clinical characteristics highlighting subgroups at-risk for weight change during a 5-year period post-diagnosis. Monitoring and interventions for weight management early in clinical care are important., (© 2023. The Author(s).)

Purpose: Successful completion of chemotherapy is critical to improve breast cancer outcomes. Relative dose intensity (RDI), defined as the ratio of chemotherapy delivered to prescribed, is a measure of chemotherapy completion and is associated with cancer mortality. The effect of exercise and eating a healthy diet on RDI is unknown. We conducted a randomized trial of an exercise and nutrition intervention on RDI and pathologic complete response (pCR) in women diagnosed with breast cancer initiating chemotherapy., Methods: One hundred seventy-three women with stage I-III breast cancer were randomly assigned to usual care (UC; n = 86) or a home-based exercise and nutrition intervention with counseling sessions delivered by oncology-certified registered dietitians (n = 87). Chemotherapy dose adjustments and delays and pCR were abstracted from electronic medical records. T-tests and chi-square tests were used to examine the effect of the intervention versus UC on RDI and pCR., Results: Participants randomly assigned to intervention had greater improvements in exercise and diet quality compared with UC ( P < .05). RDI was 92.9% ± 12.1% and 93.6% ± 11.1% for intervention and UC, respectively ( P = .69); the proportion of patients in the intervention versus UC who achieved ≥85% RDI was 81% and 85%, respectively ( P = .44). The proportion of patients who had at least one dose reduction and/or delay was 38% intervention and 36% UC ( P = .80). Among 72 women who received neoadjuvant chemotherapy, women randomly assigned to intervention were more likely to have a pCR than those randomly assigned to UC (53% v 28%; P = .037)., Conclusion: Although a diet and exercise intervention did not affect RDI, the intervention was associated with a higher pCR in patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative and triple-negative breast cancer undergoing neoadjuvant chemotherapy.

Background: Lifestyle interventions for breast cancer survivors have proved effective at stimulating positive behavior change and promoting healthy weight loss, although integrating these programs into clinical practice is challenging. We evaluated the effect of a 6-month, unsupervised, self-guided, lifestyle intervention using printed materials and online videos vs. waitlist group on body weight for breast cancer survivors. Methods: The Lifestyle, Exercise and Nutrition (LEAN) Self-Guided trial randomized breast cancer survivors with a body mass index ≥25 kg/m 2 to a 6-month lifestyle intervention (N = 102) or waitlist group (N = 103). Effects of the intervention on self-reported body weight, physical activity (PA), diet quality (via Health Eating Index-2010 (HEI-2010)), and quality of life were assessed using mixed model repeated measures analysis. Results: At 6 months, the intervention arm had significantly greater weight loss compared with the waitlist group (mean difference = -1.3 kg, 95% confidence interval [CI] = -2.5, -0.13). We observed suggestive improvements in PA (mean difference = 18.7 min/week, 95% CI = -24.2, 61.6), diet quality (mean difference in HEI = 3.2 points, 95% CI = -0.20, 6.5), and fatigue (mean difference in Functional Assessment of Chronic Illness Therapy-Fatigue scale = 1.4 points, 95% CI = -1.1, 3.9). Conclusions: The LEAN Self-Guided intervention led to favorable weight changes over 6 months. Low-resource-intensive programs have the potential to be delivered in diverse healthcare settings and may support breast cancer survivors in achieving a healthy body weight.

The NCCN Guidelines for Survivorship are intended to help healthcare professionals address the complex and varied needs of cancer survivors. The NCCN Guidelines provide screening, evaluation, and treatment recommendations for psychosocial and physical problems resulting from adult-onset cancer and its treatment; recommendations to help promote healthy behaviors and immunizations in survivors; and a framework for care coordination. These NCCN Guidelines Insights summarize recent guideline updates and panel discussions pertaining to sleep disorders, fatigue, and cognitive function in cancer survivors.

Purpose: Extending adjuvant endocrine therapy (ET) beyond the standard 5 years offers added protection against late breast cancer recurrences in women with early-stage hormone receptor-positive (HR +) breast cancer. Little is known about treatment persistence to extended ET (EET) and the role that genomic assays may play. In this study, we evaluated persistence to EET in women who had Breast Cancer Index (BCI) testing., Methods: Women with stage I-III HR + breast cancer who had BCI testing after at least 3.5 years of adjuvant ET and ≥ 7 years of follow-up after diagnosis were included (n = 240). Data on medication persistence was based on prescriptions in the electronic health record., Results: BCI predicted 146 (61%) patients to have low - BCI (H/I)-low - and 94 (39%) patients to have high likelihood of benefit from EET (BCI (H/I)-high). Continuation of ET after BCI occurred in 76 (81%) (H/I)-high and 39 (27%) (H/I)-low patients. Non-persistence rates were 19% in the (H/I)-high and 38% in the (H/I)-low group. The most common reason for non-persistence was intolerable side effects. Patients on EET underwent more DXA bone density scans than those who stopped ET at 5 years (mean 2.09 versus 1.27; p < 0.001). At a median follow-up of 10 years from diagnosis, there were 6 metastatic recurrences., Conclusions: In patients who continued ET after BCI testing, the rates of persistence to EET were high, particularly in patients with predicted high likelihood of benefit from EET. Use of EET is associated with increased use of DXA scans., (© 2023. The Author(s).)

Joy in medicine, or the loss of it, is a popular topic of conversation, even more so since the pandemic. Burnout in oncology is common and diminishes the satisfaction of practicing medicine. One of the challenges clinicians face is the way in which modern clinical practice takes us away from what we find most meaningful in our work: time with patients. Strategies like being kind, expressing gratitude, and using effective communication skills can establish more connection with our colleagues and our patients, and, in turn, result in a more joyful work environment. Creating space for more moments of feeling deep interconnectedness with patients and colleagues can rekindle feelings of joy in oncology practice. This article reviews the concepts of joy in medicine, the term sacred moments , and outlines practical strategies and communication skills that are effective in enhancing the patient-provider relationship.

Cancer cells cannot proliferate without sufficient energy to generate biomass for rapid cell division, as well as to fuel their functions at baseline. For this reason, many recent observational and interventional studies have focused on increasing energy expenditure and/or reducing energy intake during and after cancer treatment. The impact of variance in diet composition and in exercise on cancer outcomes has been detailed extensively elsewhere and is not the primary focus of this review. Instead, in this translational, narrative review we examine studies of how energy balance impacts anticancer immune activation and outcomes in triple-negative breast cancer (TNBC). We discuss preclinical, clinical observational, and the few clinical interventional studies on energy balance in TNBC. We advocate for the implementation of clinical studies to examine how optimizing energy balance-through changes in diet and/or exercise-may optimize the response to immunotherapy in people with TNBC. It is our conviction that by taking a holistic approach that includes energy balance as a key factor to be considered during and after treatment, cancer care may be optimized, and the detrimental effects of cancer treatment and recovery on overall health may be minimized., (© The Author(s) 2023. Published by Oxford University Press. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

A cancer diagnosis thrusts patients and caregivers into a foreign world of health care with systems, protocols, and norms that can leave little room for individual needs and circumstances. Quality and efficacious oncology care requires clinicians to partner with patients and caregivers to understand and incorporate their needs, values, and priorities into information sharing, decision making, and care provision. This partnership is necessary for effective patient- and family-centered care and access to individualized and equitable information, treatment, and research participation. Partnering with patients and families also requires oncology clinicians to see that our personal values, preconceived ideas, and established systems exclude certain populations and potentially lead to poorer care for all patients. Furthermore, inequitable access to participation in research and clinical trials can contribute to an unequal burden of cancer morbidity and mortality. Leveraging the expertise of the authorship team with transgender, Hispanic, and pediatric populations, this chapter provides insights and suggestions for oncology care that are applicable across patient populations to mitigate stigma and discrimination and improve the quality of care for all patients.

Background: Older adults with advanced cancer are exposed to antibiotics but estimates of adverse drug events associated with antibiotic therapy are lacking., Aim: Evaluate the association of antibiotic therapy with adverse drug events in older adults with advanced cancer., Design: Cohort study where the exposure was the ratio of days of therapy of an oral or intravenous antibiotic per patient-day and the outcome was an adverse drug event, defined as cardiotoxicity, hepatotoxicity, nephrotoxicity, Clostridioides difficile infection, or new detection of a multidrug-resistant organism., Setting/participants: Patients aged ⩾65 years with solid tumors from a tertiary care center who received palliative chemotherapy ( n  = 914)., Results: Mean age was 75 ± 6.6 years, and 52% were female. Common tumors were lung (31%, n  = 284) and gastrointestinal (26%, n  = 234). Mean time from first course of palliative chemotherapy to index admission was 128 days. Five-hundred thirty (58%) patients were exposed to antibiotics during the index admission; of these, 27% ( n  = 143) met standardized criteria for infection. Patients were commonly exposed to cephalosporins (33%, n  = 298) and vancomycin (30%, n  = 276). Among patients exposed to antibiotics, 35% ( n  = 183/530) developed an adverse drug event. In multivariable testing, antibiotic therapy was associated with development of an adverse drug event (>0 to <1 vs 0 days of therapy/patient-day: adjusted odds ratio [aOR] = 1.9; 95% confidence interval [CI], 1.2-2.8; ⩾1 vs 0 days of therapy/patient-day: aOR = 2.1, 95% CI, 1.4-3.0)., Conclusion: Antibiotic therapy was independently associated with adverse drug events in hospitalized older adults with advanced cancer. These findings may inform antibiotic decision-making among palliative care providers.

Purpose: The extent to which adults with cancer during early survivorship experienced disruptions in care due to COVID-19 pandemic, as well as their experiences with the transition to telemedicine, remains understudied., Methods: We examined cancer care disruption and satisfaction with telemedicine due to COVID-19 in 361 adults (Mage = 59.42, SD = 11.3) with breast, prostate or colorectal cancer during early survivorship. The Telemedicine Satisfaction and Usefulness Questionnaire (TSUQ) and patient self-report Cancer Care Disruption Index (CCDI) was administered via RedCap survey., Results: The most prevalent areas of patient-reported cancer care disruption included supportive care appointments canceled/postponed (57%), in-person appointments changed to virtual appointments (56%), social work services canceled (32%), palliative care appointments canceled/postponed (24%), elective surgeries related to cancer postponed (23%), and screening tests postponed (19%). Regarding patient satisfaction with telemedicine, 78.0% "agree" or "strongly agree" that they were satisfied with the overall telemedicine system. Most survivors reported satisfaction with their doctor dealing with problems (88.2%), doctors answering patient questions (92.7%), and engaged patients in care (86.1%), However, 49.3% of cancer patients disagreed that virtual visits are as satisfying as in-person visits and 35.6% were dissatisfied with the lack of physical contact during virtual visits., Conclusion: The COVID-19 pandemic disrupted cancer survivorship care, with supportive care, social work services, and mode of delivery (in-person vs. virtual) particularly affected. The downstream impact of cancer care disruption in those living with cancer during the pandemic as well as the quality of telehealth modality as part of cancer survivorship care delivery await future investigation., (© 2023. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Purpose: Most breast cancer survivors have challenges with adopting healthy lifestyle behaviors. This may be due to contextual challenges that result from the complex nature of the evidence. To address this gap, we explored the experiences of breast cancer survivors of color and oncology healthcare providers., Methods: Content analysis with inductive and deductive approaches was used for semi-structured interviews with 26 female breast cancer survivors and 10 oncology healthcare providers from Greater New Haven, Connecticut., Results: Survivors identified substantial confusion on the evidence regarding lifestyle behaviors and breast cancer, stemming from inadequate healthcare provider counseling and an overreliance on informal sources of information. Providers identified lack of evidence-based knowledge as a barrier to counseling on these topics. There was a mixed perspective regarding the consistency of evidence, stemming from a combination of gaps in the available evidence and accessing evidence-based knowledge from a wide range of professional resources. Some providers perceived the guidelines as consistent; others felt guidelines were constantly changing, impacting how and on what they counseled. Therefore, many healthcare providers in oncology care relied on generic messaging on lifestyle behaviors after a cancer diagnosis., Conclusions: Inconsistent information sources, the rapidly changing evidence, and gaps in the current evidence contribute to generic messaging about lifestyle behaviors and may inhibit a survivor's ability to engage in behavior change. Consistent and uniform healthy lifestyle guidelines for cancer outcomes may address both provider and patient level barriers to knowledge., (© 2022. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Young women with breast cancer (YWBC) report physical and psychological symptom distress after therapy but little is known about their sleep health. The purpose of this study was to identify sociodemographic, clinical, and psychosocial factors associated with sleep health and assess the potential role of appraisal of illness and coping on sleep health. An adapted cognitive appraisal and coping conceptual framework guided the study. We used a cross-sectional design with 159 women who were diagnosed with stage I-III breast cancer ≤50 years old. Sleep health was measured by the Pittsburgh Sleep Quality Index (PSQI). The mean age was 43.6 years (SD = 6.8), the majority of whom were non-Hispanic White (84%) and completed chemotherapy or radiotherapy (>70%). More than half of participants (55%) reported poor sleep health (PSQI > 8), and those with worse family functioning and from a racial/ethnic minority group were significantly more likely to have poor sleep health. Cognitive appraisal had a minimal mediation effect for anxiety on sleep health, and coping did not mediate the effect of any psychosocial variables on sleep health. Poor sleep health is a significant clinical problem in YWBC. Further research is needed to explore sleep health disparities among diverse cancer survivors and to examine sleep health in the context of family. Sleep assessment, management, and appropriate referrals to sleep providers should be part of routine survivorship care., (© 2022 Wiley Periodicals LLC.)

The NCCN Guidelines for Survivorship are intended to help healthcare professionals who work with survivors to ensure that the survivors' complex and varied needs are addressed. The NCCN Guidelines provide screening, evaluation, and treatment recommendations for the consequences of adult-onset cancer and its treatment; recommendations to help promote physical activity, weight management, and immunizations in survivors; and a framework for care coordination. This article summarizes updates to the NCCN Guidelines pertaining to preventive health for cancer survivors, including recommendations about alcohol consumption and vaccinations.

Establishing goals of care (GOC) is a crucial component of a patient's treatment plan. The need for better physician-patient communication in this area has been recognized for decades, yet several gaps remain. Challenges exist for both physician and patient. Physicians should pursue a patient-led approach, exercise cultural competency, and use various communication techniques to guide patients when establishing GOC., Competing Interests: Disclosure The authors have nothing to disclose., (Copyright © 2022 Elsevier Inc. All rights reserved.)

New approaches to cancer survivorship care must address the rising number of survivors who need complex care; the need to personalize care to improve health equity; workforce shortages and clinician knowledge deficits about the long-term and late effects of cancer; the need to engage and coordinate oncology, primary care, and a large multidisciplinary team of subspecialists and programs to meet survivors' needs; and the need to control costs and deliver better value. This review proposes eight core tenets of an evolved standard of care to meet these needs by starting at diagnosis and continuing throughout oncology and into follow-up to: (1) facilitate team medicine by connecting oncology, primary care, subspecialists and programs, researchers, and patients and caregivers; (2) educate patients and support them in self-management; (3) mitigate toxicities; (4) manage comorbidities; (5) promote healthy behaviors and wellness; (6) improve health equity; (7) provide clear personalized follow-up; and (8) provide ongoing opportunities for participation in research as the standard of care. Strategies to successfully implement this care are discussed from the perspectives of oncology, primary care, and health care administration.

Few trials have examined the effect of lifestyle behavioral interventions on tissue markers in patients with cancer. The purpose of this study was to examine the feasibility and impact of a 6-month weight loss intervention on breast tissue and serum biomarkers in women with breast cancer. Fifty-one women who completed breast cancer treatment and had a BMI ≥ 25.0 kg/m 2 were randomized to a weight loss intervention or usual care. Breast tissue biopsies, fasting blood draw and body composition were collected at baseline and 6 months, with between-group changes examined using analysis of covariance method. Baseline and post-intervention biopsies were conducted in 49 and 42 women, respectively, with pre- and post-epithelial tissue available from 25 tissue samples. Average 6-month weight loss was 6.7% for the weight loss group and 2.0% increase for the usual care group (p < 0.0001). At baseline, body fat and serum insulin levels were inversely associated with breast tissue insulin receptor levels and CD68 (p < 0.05). At 6 months, favorable changes were observed in serum leptin and adiponectin levels and tissue CD163 among women randomized to weight loss vs. adverse change in women randomized to usual care (p < 0.05). Breast tissue biopsies are feasible to collect in a clinical research setting among breast cancer survivors, with weight loss favorably impacting metabolic and inflammatory markers associated with breast cancer., (© 2022. The Author(s).)

The use of dietary supplements is common in the general population and even more prevalent among cancer survivors. The World Cancer Research Fund/American Institute for Cancer Research specifies that dietary supplements should not be used for cancer prevention. Several dietary supplements have potential pharmacokinetic and pharmacodynamic interactions that may change their clinical efficacy or potentiate adverse effects of the adjuvant endocrine therapy prescribed for breast cancer treatment. This analysis examined the prevalence of self-reported dietary supplement use and the potential interactions with tamoxifen and aromatase inhibitors (AIs) among breast cancer survivors enrolled in three randomized controlled trials of lifestyle interventions conducted between 2010 and 2017. The potential interactions with tamoxifen and AIs were identified using the Natural Medicine Database. Among 475 breast cancer survivors (2.9 (mean) or 2.5 (standard deviation) years from diagnosis), 393 (83%) reported using dietary supplements. A total of 108 different types of dietary supplements were reported and 36 potential adverse interactions with tamoxifen or AIs were identified. Among the 353 women taking tamoxifen or AIs, 38% were taking dietary supplements with a potential risk of interactions. We observed a high prevalence of dietary supplement use among breast cancer survivors and the potential for adverse interactions between the prescribed endocrine therapy and dietary supplements was common.

Background: The World Cancer Research Fund and the American Cancer Society provide nutrition and physical activity guidelines for cancer survivors. Many women with breast cancer do not follow these guidelines and delay efforts toward following them until active treatment is complete. However, adoption of these recommended lifestyle behaviors soon after diagnosis may prevent adverse treatment-related side effects and may improve adherence to treatment, resulting in improved breast cancer prognosis. The Lifestyle, Exercise, and Nutrition Early after Diagnosis (LEANer) study is testing the effect of a nutrition and physical activity intervention on chemotherapy completion rates., Methods: 172 women with stage I-III breast cancer undergoing chemotherapy will be randomized 1:1 to a yearlong, 16 session, nutrition and exercise intervention or usual care control group. The intervention is delivered by registered dietitians specializing in oncology nutrition and exercise training. The intervention includes goal setting to meet nutrition and physical activity guidelines for cancer survivors. After each chemotherapy session, date and dose of each drug administered, and reason for dose-adjustments and/or dose-delays are abstracted from the electronic medical record or obtained from the treating oncologist. Chemotherapy completion rate is assessed as the average relative dose-intensity (RDI) for the originally planned regimen based on standard formulas. Secondary endpoints of endocrine therapy adherence, treatment-related side effects, and changes in inflammatory and metabolic biomarkers, body composition, and patient reported outcomes are assessed at four timepoints., Discussion: If successful, this study has the potential to make healthy lifestyle interventions a standard component of breast cancer treatment., (Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.)

Lifestyle interventions among breast cancer survivors with obesity have demonstrated successful short-term weight loss, but data on long-term weight maintenance are limited. We evaluated long-term weight loss maintenance in 100 breast cancer survivors with overweight/obesity in the efficacious six-month Lifestyle, Exercise, and Nutrition (LEAN) Study (intervention = 67; usual care = 33). Measured baseline and six-month weights were available for 92 women. Long-term weight data were obtained from electronic health records. We assessed weight trajectories between study completion (2012-2013) and July 2019 using growth curve analyses. Over up to eight years (mean = 5.9, SD = 1.9) of post-intervention follow-up, both the intervention ( n = 60) and usual care ( n = 32) groups declined in body weight. Controlling for body weight at study completion, the yearly weight loss rate in the intervention and usual care groups was -0.20 kg (-0.2%/year) (95% CI: 0.06, 0.33, p = 0.004) and -0.32 kg (-0.4%/year) (95% CI: 0.12, 0.53, p = 0.002), respectively; mean weight change did not differ between groups ( p = 0.31). It was encouraging that both groups maintained their original intervention period weight loss (6% intervention, 2% usual care) and had modest weight loss during long-term follow-up. Breast cancer survivors in the LEAN Study, regardless of randomization, avoided long-term weight gain following study completion.

Purpose: Standard-of-care treatment for metastatic hormone receptor-positive (HR + ), HER2-negative (HER2 - ) breast cancer includes endocrine therapy (ET) combined with a cyclin-dependent kinase 4/6 inhibitor (CDK4/6i). Optimal treatment after progression on CDK4/6i is unknown. The TRINITI-1 trial investigated ribociclib, a CDK4/6i that has recently demonstrated significant overall survival benefit in two phase III trials, in combination with everolimus and exemestane in patients with HR + , HER2 - advanced breast cancer (ABC) after progression on a CDK4/6i., Patients and Methods: This multicenter, open-label, single-arm, phase I/II study included patients with locally advanced/metastatic HR + /HER2 - breast cancer. The primary endpoint was clinical benefit rate (CBR) at week 24 among patients with ET-refractory disease with progression on a CDK4/6i. Other endpoints included safety and biomarker analysis., Results: Of 104 patients enrolled (phases I and II), 96 had prior CDK4/6i. Recommended phase II doses (all once daily days 1-28 of 28-day cycle) were ribociclib 300 mg, everolimus 2.5 mg, and exemestane 25 mg (group 1) and ribociclib 200 mg, everolimus 5 mg, and exemestane 25 mg (group 2). CBR among 95 efficacy-evaluable patients (phases I and II) at week 24 was 41.1% (95% confidence interval, 31.1-51.6), which met the primary endpoint (predetermined threshold: 10%). Common adverse events included neutropenia (69.2%) and stomatitis (40.4%). No new safety signals were observed; no grade 3/4 QTc prolongation was reported., Conclusions: Preliminary TRINITI-1 safety and efficacy results support further investigation of CDK4/6 blockade and targeting of the PI3K/AKT/mTOR signaling pathway in patients with ET-refractory HR + /HER2 - ABC after progression on a CDK4/6i., (©2021 American Association for Cancer Research.)

The NCCN Guidelines for Survivorship are intended to help healthcare professionals working with cancer survivors to ensure that each survivor's complex and varied needs are addressed. The Guidelines provide screening, evaluation, and treatment recommendations for consequences of adult-onset cancer and its treatment; recommendations to help promote healthful lifestyle behaviors, weight management, and immunizations in survivors; and a framework for care coordination. This article summarizes the recommendations regarding employment and return to work for cancer survivors that were added in the 2021 version of the NCCN Guidelines.

Purpose: Our study examined whether common variants of obesity-associated genes FTO, MC4R, BDNF, and CREB1 moderated the effects of a lifestyle intervention on weight change among breast cancer survivors., Methods: 151 breast cancer survivors with a body mass index ≥ 25 kg/m 2 were randomly assigned to a 6-month weight loss intervention or usual care group. Genotyping of FTO rs9939609, MC4R rs6567160, BDNF rs11030104, CREB1 rs17203016 was performed. Linear mixed models were used including the main effects of genotype (assuming a dominant genetic model), treatment arm on weight and percent body fat changes, and genotype by treatment interaction variable. All statistical tests were evaluated against a Bonferroni-corrected alpha of 0.0125., Results: Women in the intervention group achieved significantly greater weight loss than the usual care group (5.9% vs 0.4%, p < 0.001), regardless of genotype. Changes in weight and percent body fat did not differ significantly between carriers of the FTO rs9939609, MC4R rs6567160, BDNF rs11030104, and CREB1 rs17203016 risk alleles compared to non-carriers (p-interaction > 0.0125 for each single-nucleotide polymorphisms)., Conclusions: Women who are genetically predisposed to obesity and recently diagnosed with breast cancer may achieve significant and clinically meaningful weight loss through healthy eating and exercise., Clinical Trial Registration: NCT02863887 (Date of Registration: August 11, 2016); NCT02110641 (Date of Registration: April 10, 2014).

Obesity among breast cancer survivors is associated with increased risk for recurrence and mortality. The hormone ghrelin plays a role in initiating appetite and thus regulating body weight. This study aims to determine the effect of a lifestyle intervention on ghrelin levels in breast cancer survivors with a body mass index (BMI) ≥ 25 kg/m 2 . The Lifestyle, Exercise, and Nutrition (LEAN) study was a 6-month randomized trial, examining the effectiveness of a weight loss intervention versus usual care in 151 breast cancer survivors with BMI ≥ 25 kg/m 2 . Ghrelin was measured in fasting baseline and 6-month blood samples. Baseline associations between ghrelin, body composition, and blood biomarkers were examined. Six-month change in ghrelin was compared between study arms. Ghrelin measurements were available for 149 women. At baseline, ghrelin was correlated with age (r = 0.28, p < 0.001) and inversely correlated with weight (r = -0.18, p = 0.03), lean body mass (r = -0.18, p = 0.02), and leptin (r = -0.18, p = 0.03). Over 6 months, ghrelin increased by 144 pg/mL (7.2%) in the intervention and decreased by 466 pg/mL (32.5%) in the usual care (p = 0.07). Among all women, greater weight loss was associated with an increase in ghrelin (p = 0.01). These findings indicate that weight loss, achieved through a lifestyle intervention, is associated with higher ghrelin levels in breast cancer survivors which may be informative for developing sustainable weight loss programming for this population. Future research should investigate the long term impacts of lifestyle interventions on ghrelin levels in the context of weight maintenance and weight regain.

Purpose: Previous work found that lower BMI is associated with a pathologic complete response (pCR) following neoadjuvant chemotherapy for breast cancer. Relative dose intensity (RDI) of chemotherapy is an important marker of treatment tolerability. We hypothesized that patients with low BMI would have higher RDI than patients with high BMI, explaining the mechanism for the association between BMI and pCR., Methods: We conducted a retrospective study of women treated with neoadjuvant chemotherapy for stage I-III breast cancer at Yale New Haven Hospital-Smilow Cancer Hospital. We reviewed medical records to determine tumor characteristics, chemotherapy doses, and reasons for dose reductions or delays. The treatment RDI was calculated using published methods. Chi-squared analyses were conducted to determine the associations between RDI and BMI and between RDI and pCR., Results: Our cohort (n = 237) had an average age of 53 years (SD 13) and mean BMI of 29.5 kg/m 2 (SD 7.0). Fifty-eight patients (24%) received <85% RDI, and 61% of patients experienced at least one dose reduction or delay. BMI was not associated with RDI (p = 0.71), and RDI was not associated with pCR (p = 0.31); however, fewer dose delays was associated with pCR (p = 0.02). The most common reasons for dose reduction or delays were neuropathy, myelosuppression, and personal reasons., Conclusions: Nearly one quarter of our cohort had RDI <85%. Although RDI overall was not associated with pCR, having fewer dose delays was associated with pCR. Our results highlight a need for improved patient adherence to and tolerability of neoadjuvant chemotherapy to minimize treatment delays.

Background: Antimicrobial use during end-of-life care of older adults with advanced cancer is prevalent. Factors influencing the decision to prescribe antimicrobials during end-of-life care are not well defined., Aim: To evaluate factors influencing medicine subspecialists to prescribe intravenous and oral antimicrobials during end-of-life care of older adults with advanced cancer to guide an educational intervention., Design: 18-item single-center cross-sectional survey., Setting/participants: Inpatient medicine subspecialists in 2018., Results: Of 186 subspecialists surveyed, 67 (36%) responded. Most considered withholding antimicrobials at the time of clinical deterioration during hospitalization ( n = 54/67, 81%), viewed the initiation of additional intravenous antimicrobials as escalation of care ( n = 44/67, 66%), and believed decision-making should involve patients or surrogates and providers ( n = 64/67, 96%). Fifty-one percent ( n = 30/59) of respondents who conducted advance care planning did not discuss antimicrobials. Barriers to discussing end-of-life antimicrobials included the potential to overwhelm patients or families, challenges of withdrawing antimicrobials, and insufficient training., Conclusions: Although the initiation of additional intravenous antimicrobials was viewed as escalation of care, antimicrobials were not routinely discussed during advance care planning. Educational interventions that promote recognition of antimicrobial-associated adverse events, incorporate antimicrobial use into advance care plans, and offer communication simulation training around the role of antimicrobials during end-of-life care are warranted.

Observational studies report that physical activity and metformin are associated with improved clinical outcome in patients with cancer. Inflammation is one biological mechanism hypothesized to mediate these associations. In this phase II, multicenter, 2 × 2 factorial trial, 139 patients with breast and colorectal cancer who completed standard therapy were randomized to one of four treatment groups for 12 weeks: exercise alone, metformin alone, exercise and metformin, or control. Inflammation outcomes included high-sensitivity C-reactive protein (hs-CRP), soluble tumor necrosis factor alpha receptor two (sTNFαR2), and IL6. The primary modeling strategy evaluated the trial product estimand that was quantified using a generalized linear mixed model. Compared with control, exercise alone reduced hs-CRP [-30.2%; 95% confidence interval (CI), -50.3, -1.0] and IL6 (-30.9%; 95% CI, -47.3, -9.5) but did not change sTNFαR2 (1.0%; 95% CI, -10.4, 13.9). Compared with control, metformin alone did not change hs-CRP (-13.9%; 95% CI, -40.0, 23.4), sTNFαR2 (-10.4%; 95% CI, -21.3, 2.0), or IL6 (-22.9%; 95% CI, -42.3, 2.0). Compared with control, exercise and metformin reduced sTNFαR2 (-13.1%; 95% CI, -22.9, -1.0) and IL6 (-38.7%; 95% CI, -52.3, -18.9) but did not change hs-CRP (-20.5%; 95% CI, -44.0, 12.7). The combination of exercise and metformin was not synergistic for hs-CRP, sTNFαR2, or IL6. In survivors of breast and colorectal cancer with low baseline physical activity and without type 2 diabetes, exercise and metformin reduced measures of inflammation that are associated with cancer recurrence and mortality., (©2020 American Association for Cancer Research.)

The NCCN Guidelines for Survivorship provide screening, evaluation, and treatment recommendations for consequences of adult-onset cancer and its treatment, with the goal of helping healthcare professionals who work with survivors, including those in primary care. The guidelines also provide recommendations to help clinicians promote physical activity, weight management, and proper immunizations in survivors and facilitate care coordination to ensure that all of the survivors' needs are addressed. These NCCN Guidelines Insights summarize additions and changes made to the guidelines in 2020 regarding cardiovascular disease risk assessment and screening for subsequent primary malignancies.