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Background: Implementation strategies are crucial to facilitate implementation success. To prepare and support implementation of a clinical pathway for screening, assessment and management of anxiety and depression in cancer patients (the ADAPT CP), six broad categories of implementation strategies; (1) Awareness campaigns, (2) Champions, (3) Education, (4) Academic Detailing and Support, (5) Reporting, (6) Technological Support, were developed. The aim of this paper is to describe the fidelity and acceptability of six categories of implementation strategies and any subsequent changes/adaptations made to those strategies. Methods: The ADAPT CP was implemented in twelve cancer services in NSW, Australia, as part of a cluster randomised controlled trial of core versus enhanced implementation strategies. Fidelity to and any subsequent changes to the delivery of the planned six categories of implementation strategies were captured using the ADAPT contact log, which recorded the contacts made between the ADAPT research team and services, engagement meetings and monthly meetings. To explore acceptability and awareness/engagement with the implementation strategies, interviews with a purposively selected staff sample across both study arms were held prior to implementation (T0), six months into implementation (T1) and at the end of the 12-month implementation period (T2). Interviews were thematically analysed across the six categories of strategies. Results: Delivery of all six categories of implementation strategies as planned was moderated by service context and resources and staff engagement. As such, for some implementation strategies, subsequent changes or adaptations to the content, mode of delivery, frequency and duration such as abbreviated training sessions, were made to optimise fidelity to and engagement with the strategies. Most strategies were perceived to be acceptable by service staff. Use of strategies prior to implementation of the ADAPT CP such as the engagement meetings and training sessions, positively impacted on ownership and preparedness to implement the ADAPT CP. Furthermore, ongoing support such as provision of additional training or monthly meetings facilitated increased awareness and engagement with the ADAPT program. Conclusion: Flexibility in delivering implementation strategies, and ensuring staff engagement with, and acceptability of those strategies, can support implementation of interventions within healthcare settings. Trial registration: The ADAPT CRCT was registered prospectively with the ANZCTR on 22/3/2017. Trial ID ACTRN12617000411347. https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=372486&isReview=true [ABSTRACT FROM AUTHOR]

Background: Optimal strategies to facilitate implementation of evidence-based clinical pathways are unclear. We evaluated two implementation strategies (Core versus Enhanced) to facilitate implementation of a clinical pathway for the management of anxiety and depression in cancer patients (the ADAPT CP). Methods: Twelve cancer services in NSW Australia were cluster randomised, stratified by service size, to the Core versus Enhanced implementation strategy. Each strategy was in place for 12 months, facilitating uptake of the ADAPT CP (the intervention being implemented). The Core strategy included a lead team with champions, staff training and awareness campaigns prior to implementation, plus access to feedback reports and telephone or online support during implementation. The Enhanced strategy included all Core supports plus monthly lead team meetings, and proactive, ongoing advice on managing barriers, staff training and awareness campaigns throughout implementation. All patients at participating sites were offered the ADAPT CP as part of routine care, and if agreeable, completed screening measures. They were allocated a severity step for anxiety/depression from one (minimal) to five (severe) and recommended management appropriate to their severity step. Multi-level mixed-effect regression analyses examined the effect of Core versus Enhanced implementation strategy on adherence to the ADAPT CP (binary primary outcome: adherent ≥ 70% of key ADAPT CP components achieved versus non-adherent < 70%), with continuous adherence as a secondary outcome. Interaction between study arm and anxiety/depression severity step was also explored. Results: Of 1280 registered patients, 696 (54%) completed at least one screening. As patients were encouraged to re-screen, there were in total 1323 screening events (883 in Core and 440 in Enhanced services). The main effect of implementation strategy on adherence was non-significant in both binary and continuous analyses. Anxiety/depression step was significant, with adherence being higher for step 1 than for other steps (p = 0.001, OR = 0.05, 95% CI 0.02–0.10). The interaction between study arm and anxiety/depression step was significant (p = 0.02) in the continuous adherence analysis only: adherence was significantly higher (by 7.6% points (95% CI 0.08–15.1%) for step 3 in the Enhanced arm (p =.048) and trending to significance for step 4. Discussion: These results support ongoing implementation effort for the first year of implementation to ensure successful uptake of new clinical pathways in over-burdened clinical services. Trial registration: ANZCTR Registration: ACTRN12617000411347 (Trial registered 22/03/2017; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=372486&isReview=true) [ABSTRACT FROM AUTHOR]

Background: Advanced biliary tract cancer (ABTC) is a highly aggressive malignancy, with a 5‐year overall survival of < 10%. Although preliminary evidence suggests a role of targeted treatments or immunotherapy in a subset of patients, chemotherapy remains the standard second‐line treatment in the majority. We conducted a pilot study of second‐line chemotherapy with capecitabine and nab‐paclitaxel after failure of gemcitabine and platinum. Methods: Eligible patients had histologically proven, unresectable biliary tract cancer, which had progressed on a gemcitabine/platinum doublet. In this single‐arm, multicenter trial, all patients received capecitabine (825 mg/m2 bd PO D1‐14 q21d) and nab‐paclitaxel (125 mg/m2 IV D1,8 q21d) until progression or unacceptable toxicity. The primary objective was feasibility of delivering the proposed regimen, with secondary objectives of disease control measures and QOL outcomes. Results: Ten patients were enrolled between 2015 and 2016 from four cancer centers in NSW. Treatment was generally well tolerated with grade III toxicities in five patients (including infection, cholangitis, obstruction, and intestinal perforation) and no grade IV toxicity. Median treatment duration was 4.3 months, with a disease control rate of 80% (8/10), and median progression‐free and overall survival of 5.7 and 12.1 months, respectively. Quality of life data and specimens for translational research have been collected. Conclusions: Our pilot study demonstrates that combination of capecitabine and nab‐paclitaxel is feasible as a second‐line treatment in ABTC. Adequate safety and promising early efficacy signals make further assessment of the combination in a formal phase II or III trial reasonable. Clinical trial information: ACTRN12615000504516. [ABSTRACT FROM AUTHOR]

Introduction: Earlier access to lung cancer specialist (LCS) care improves survival. We examined times to diagnosis and treatment of patients with lung cancer in rural and metropolitan New South Wales (NSW) Australia, benchmarked against recent timeframe recommendations. Materials and Methods: Semistructured interviews of recently diagnosed patients with lung cancer from five NSW cancer centers were used to determine standardized time intervals to diagnosis and treatment, triangulated with Medicare data linkage and medical records. We used descriptive statistics to evaluate the primary end points of median time intervals from general practitioner (GP) referral to first LCS visit (GP-LCS interval) and to treatment start (Secondary Care interval). Univariable and multivariable analyses were used to study associations with delays in end points. Post hoc survival analyses were performed. Results: Data linkage was performed for 125 patients (68% stage IV; 69% metropolitan), with 108 interviewed. The median GP-LCS interval was 4 days, with 83% of patients seeing an LCS within the recommended 14 days. The median Secondary Care interval was 42 days (52% within 42 days). There were no significant differences between time intervals faced by rural and metropolitan patients overall, although metropolitan patients took 18 days less than rural counterparts to commence radiation/chemoradiation (95% CI, −33.2 to −2.54; P =.02). One third of patients perceived delays. Delays did not affect survival. Conclusion: Rural and metropolitan NSW patients face comparable time lines to diagnosis and treatment of lung cancer. Most patients are seen by an LCS within recommended timeframes, but transition through Secondary Care and addressing patient expectations could be improved. [ABSTRACT FROM AUTHOR]