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Purpose: Fear of cancer recurrence (FCR) is a common distressing condition. We investigated the efficacy of smartphone problem-solving therapy and behavioral activation applications in breast cancer survivors., Methods: This was a decentralized randomized trial. Participants were disease-free breast cancer survivors age 20-49 years who were randomly assigned to the smartphone-based intervention or waitlist control. Both groups received treatment as usual. The control group could access the smartphone apps during weeks 8-24. The intervention comprised smartphone problem-solving therapy and behavioral activation apps. The primary end point was the Concerns About Recurrence Scale at week 8. Secondary outcomes included the Fear of Cancer Recurrence Inventory-Short Form (FCRI-SF), the Hospital Anxiety and Depression Scale (HADS), the Short-form Supportive Care Needs Survey (SCNS-SF34), and the Posttraumatic Growth Inventory at weeks 8 and 24 (trial registration: UMIN-CTR: UMIN000031140)., Results: The intervention group included 223 participants, and the control group included 224 participants. Primary outcome data were obtained for 444 participants, and 213 participants in the intervention arm completed the week 24 assessment. The intervention group had statistically greater improvements than controls at week 8 on the Concerns About Recurrence Scale (difference -1.39; 95% CI, -1.93 to -0.85; P < .001), FCRI-SF (difference -1.65; 95% CI, -2.41 to -0.89; P < .001), HADS depression (difference -0.49; 95% CI, -0.98 to 0; P < .05), and SCNS-SF34 psychological domain (difference -1.49; 95% CI, -2.67 to -0.32; P < .05). These scores at week 24 were not statistically significant compared with week 8 although the HADS depression score at week 24 was significantly reduced ( P = .03)., Conclusion: Novel smartphone psychotherapy offers a promising way to reduce FCR given the large number of survivors and a limited number of therapists to competently conduct psychotherapy.

Objectives: Our newly developed brief collaborative care intervention program has been suggested to be effective in reducing breast cancer patients' unmet needs and psychological distress; however, there has been no controlled trial to investigate its effectiveness. The purpose of this study was to examine the effectiveness of the program in relation to patients' perceived needs and other relevant outcomes for patients including quality of life, psychological distress and fear of recurrence (Clinical trial register; UMIN-CTR, Clinical registration number; R5172)., Methods: Fifty-nine highly distressed breast cancer patients receiving adjuvant chemotherapy and/or hormonal therapy were randomly assigned either to a treatment as usual group or to a collaborative care intervention, consisting of four sessions that mainly included assessment of the patients' perceived needs, learning skills of problem-solving treatment for coping with unmet needs and psycho-education provided by trained nurses supervised by a psycho-oncologist., Results: Although >80% of the eligible patients agreed to participate, and >90% of participants completed the intervention, there were no significant differences with regard to patients' needs, quality of life, psychological distress and fear of recurrence, both at 1 and 3 months after intervention., Conclusion: Newly developed brief collaborative care intervention program was found to be feasible and acceptable. The trial, however, failed to show the effectiveness of the program on patients' relevant subjective outcomes. Further intervention program having both brevity and sufficient intensity should be developed in future studies., (© The Author(s) 2020. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Objectives: The purpose of this study was to investigate a newly developed smartphone problem-solving therapy (PST) application's feasibility and preliminary effectiveness for reducing fear of cancer recurrence (FCR) among breast cancer survivors., Methods: Female disease-free breast cancer survivors aged 20-49 years who were more than 6 months post-breast surgery participated in the study. The patients received the smartphone PST using an iPhone or iPad for 8 weeks. The feasibility of the intervention program was evaluated using the overall participation rate, the percentage of survivors who expressed interest in the intervention, and the percentage of completion of the study. Patients were also asked to complete the Concern About Recurrence Scale (CARS) as a primary outcome at baseline, 4 weeks and 8 weeks., Results: A total of 38 patients participated in this study. The overall participation and completion rates in the study were 47.1% and 97.4%, respectively. The overall fear assessed by CARS was significantly reduced at 8 weeks compared with baseline. A pairwise comparison showed a significant decrease from 4 weeks to 8 weeks and from baseline to 8 weeks., Conclusions: Smartphone PST, a novel brief intervention to reduce FCR, was well accepted by breast cancer survivors and yielded a favorable effect on FCR. The efficacy of this newly developed smartphone PST needs to be confirmed in a future well-designed randomized controlled trial., (© The Author(s) 2019. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Introduction: One of the most common distressing conditions experienced by breast cancer survivors is fear of cancer recurrence (FCR). There is, however, no standard intervention for ameliorating FCR. Our clinical experience and previous studies have suggested the potential benefits of problem-solving therapy (PST) and behavioural activation (BA). Given the huge number of cancer survivors and limited number of therapists to competently conduct PST and BA, we have developed PST and BA smartphone applications. This study aimed to evaluate the efficacy of the smartphone-based PST (Kaiketsu-App) and BA (Genki-App) apps in reducing FCR in patients with breast cancer., Methods and Analysis: The SMartphone Intervention to LEssen fear of cancer recurrence project is an open-label, individually randomised, parallel-group trial. Allocation will be managed by a central server using a computer-generated random allocation sequence provided by an independent data centre. Participants will be randomised to smartphone-based intervention plus treatment as usual (TAU) or waitlist control with TAU alone. The primary endpoint of the study is the Japanese version of the Concerns About Recurrence Scale, which will be administered as an electronic patient-reported outcome on the patients' smartphone after 8 weeks., Ethics and Dissemination: The present study is subject to the ethical guidelines for clinical studies published by Japan's Ministry of Education, Science and Technology and Ministry of Health, Labour and Welfare and the modified Act on the Protection of Personal Information as well as the ethical principles established for research on humans stipulated in the Declaration of Helsinki and further amendments thereto. The protocol was approved by the Institutional Review Board of Nagoya City University on 15 January 2018 (ID: 60-00-1171)., Trial Status: The randomised trial, which commenced on 2 April 2018, currently enrols participants. The estimated end date for this study is in March 2020., Trial Registration Number: UMIN000031140; Pre-results., Competing Interests: Competing interests: TA has received lecture fees from AstraZeneca, Daiichi-Sankyo, Dainippon-Sumitomo, Eizai, Hisamitsu, Lilly, MSD, Meiji-seika Pharma, Mochida, Pfizer, Novartis, Otsuka, Shionogi, Takeda, Tanabe-Mitsubishi, Terumo and Yoshitomi. TA has received research funds from Daiichi-Sankyo, Eizai, MSD, Pfizer, Novartis and Tanabe-Mitsubishi. TY received research funds from AC MEDICAL, A2 Healthcare, CAC Croit, FMD K&L Japan, Japan Tobacco, Japan Media, Luminary Medical, Medidata Solutions, ONO PHARMACEUTICAL, Kyowa Hakko Kirin and DAIICHI SANKYO. TY received consulting fees from ONO PHARMACEUTICAL, Kowa, Japan Tobacco, CHUGAI PHARMACEUTICAL, TSUMURA & CO, CAC Croit, ASAHI INTECC, Asahi Kasei Pharma and Clinical Trial. FK has received lecture fees from MSD. TAF has received lecture fees from Janssen, Meiji, Mitsubishi-Tanabe, MSD and Pfizer. He has received research support from Mitsubishi-Tanabe. HI has received lecture fees from Daiichi Sankyo, Chugai, AstraZeneca, Pfizer and Eisai. He has received research support from Daiichi Sankyo, Chugai, AstraZeneca, Pfizer, MSD, Kyowahakou Kirin, GSK, Lilly, Novartis and Bayer. YU has received lectures fees from Asteras, Daiichi-Sankyo, Dainippon-Sumitomo, Eizai, Jannsen, Kyowahakko-Kirin, Ono, Meiji-seika Pharma, Mochida, Pfizer, Novartis, Otsuka, Sawai, Shionogi, Taiho, Tanabe-Mitsubishi and Tsumura Pharma., (© Author(s) (or their employer(s)) 2018. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objective: This study aimed to investigate the feasibility of an intervention program for women with breast cancer undergoing adjuvant anticancer therapy, and determine its preliminary effectiveness in reducing their unmet needs and psychological distress., Methods: The intervention was based on the collaborative care model, and compromised four domains: identification of unmet needs, problem-solving therapy and behavioral activation supervised by a psychiatrist, psychoeducation and referral to relevant departments. Eligible women with breast cancer were provided the collaborative care intervention over four sessions. The feasibility of the program was evaluated by the percentage of women who entered the intervention and by the percentage of adherence to the program. Self-reported outcomes were measured by the Supportive Care Needs Survey-Short Form 34 (SCNS-SF34), the Profile of Mood States (POMS), the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), the Concern about Recurrence Scale, and pre- and post-intervention satisfaction with medical care., Results: In total, 40 patients participated in this study. The rate of participation in the intervention was 68%, and the rate of adherence was 93%. Participants had significantly improved scores on total perceived needs, physical needs and psychological needs on the SCNS-SF34; vigor and confusion on the POMS and function (physical, emotional and cognitive), nausea and vomiting, dyspnea, appetite loss and financial difficulties on the EORTC QLQ-C30 compared with the baseline assessment., Conclusions: Our findings indicated the intervention program was feasible. Further study is needed to demonstrate the program's effectiveness in reducing unmet needs., (© The Author 2016. Published by Oxford University Press.)

Objective: This study investigates the prevalence of clinical anxiety, the possible impact of patients' anxiety on quality of life and the association between their anxiety levels and patients' perceived needs., Methods: Randomly selected disease-free patients with breast cancer who survived >2 years were invited to participate in the study. The participants were asked to complete the Hospital Anxiety and Depression Scale, the European Organization for Research and Treatment of Cancer QLQ-C 30 and the Short-form Supportive Care Needs Survey questionnaire, which covers five domains of need (health system and information, psychological, physical, care and support and sexuality needs)., Results: Complete data were available for 146 of the patients, and 14% of them suffered from clinical anxiety. Anxiety score had a statistically significant correlation with all domains of quality-of-life measures. The only perceived need that was significantly associated with anxiety was the psychological domain., Conclusions: Not negligible patients may suffer from clinical anxiety >2 years after their initial cancer diagnoses. Anxiety can impact on patients' quality of life, and unmet psychological needs are expected to increase anxiety levels. Management of anxiety could be one of the key components to improving the quality of life for breast cancer survivors and that reducing their unmet psychological needs may contribute to alleviating anxiety., (© The Author 2015. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.)

Objective: Although the fear of recurrence is a major concern among breast cancer survivors after their surgery, there are no instruments to evaluate their distress in Japan. This study examines the psychometric properties of the Japanese version of the concerns about recurrence scale, which was originally developed in the USA., Methods: The forward and backward translation method was used to develop Concerns About Recurrence Scale. Randomly selected ambulatory female patients with breast cancer participated in this study. They were asked to complete Japanese version of the concerns about recurrence scale and Hospital Anxiety and Depression Scale. The validity and reliability of Japanese version of the concerns about recurrence scale were evaluated statistically., Results: Data were obtained from 375 patients. A novel four-factor solution was found (Health and Death Worries, Womanhood Worries, Self-valued Worries and Role Worries) that accounted for 59.2% of the total variance. Correlation coefficients between the Japanese version of the concerns about recurrence scale subscale scores and the anxiety score measured by Hospital anxiety and depression scale ranged from 0.39 to 0.60. Cronbach's alpha coefficients, which are measures of the internal consistency of the subscales, ranged from 0.86 to 0.94., Conclusions: The results suggest that Japanese version of the concerns about recurrence scale is a reliable and valid clinical research tool to evaluate the fear of recurrence among patients with breast cancer in Japan, although there may be cross-cultural differences regarding factor structures between Western and Japanese breast cancer patients.

Although fear of recurrence is a major concern among breast cancer survivors after surgery, no standard strategies exist that alleviate their distress. This study examined the association of patients' problem-solving skills and fear of recurrence and psychological distress among breast cancer survivors. Randomly selected, ambulatory, female patients with breast cancer participated in this study. They were asked to complete the Concerns about Recurrence Scale (CARS) and the Hospital Anxiety and Depression Scale. Multiple regression analyses were used to examine their associations. Data were obtained from 317 patients. Patients' problem-solving skills were significantly associated with all subscales of fear of recurrence and overall worries measured by the CARS. In addition, patients' problem-solving skills were significantly associated with both their anxiety and depression. Our findings warrant clinical trials to investigate effectiveness of psychosocial intervention program, including enhancing patients' problem-solving skills and reducing fear of recurrence among breast cancer survivors.

Objective: The current report provides the result of a Phase II clinical trial regarding the effectiveness and feasibility of problem-solving therapy for psychological distress experienced by Japanese early-stage breast cancer patients., Methods: Participants were 36 post-surgery Japanese breast cancer patients in a university hospital located in Osaka Prefecture, Japan. After screening for psychological distress using the Distress and Impact Thermometer and the Hospital Anxiety and Depression Scale, highly distressed patients were exposed to 5 weekly sessions of the problem-solving therapy program., Results: Nineteen patients completed the intervention and follow-up. There was a significant difference between the pre-intervention and the 3-month follow-up in the total Hospital Anxiety and Depression Scale score (P = 0.02), and the mean change score from the pre-intervention to the follow-up was 6.05 (SD = 1.94). The intervention had a large effect size (d = 0.82). There were also significant changes in worry, self-efficacy and quality of life measures., Conclusions: The findings of our study suggest that the problem-solving therapy program has potential to be effective for alleviating psychological distress experienced by Japanese early-stage breast cancer patients. The true effectiveness of the program should be confirmed by a future randomized control trial.

Problem-solving therapy (PST) is a brief, structured psychological treatment. Preliminary clinical findings regarding the effectiveness of PST for treating psychological distress experienced by Japanese cancer patients are presented. Our actual clinical experience in administering PST to four consecutive distressed cancer patients was reviewed. All of the patients were breast cancer survivors who were referred to us after undergoing surgery. Three cases received six PST sessions each and one case received three PST sessions. The depression and anxiety scores decreased after PST. Our preliminary experience suggests that PST is an effective treatment for alleviating psychological distress in Japanese cancer patients and that this treatment should be further examined in a clinical trial.