A novel clinician-delivered intervention to reduce fear of recurrence in breast cancer survivors: Results from a Phase I/II implementation study (CIFeR_2).

OBJECTIVE: Fear of cancer recurrence (FCR) is highly prevalent, however there is no formal training for clinicians to address FCR. A novel brief clinician intervention to help patients manage FCR (Clinician Intervention to Reduce Fear of Recurrence (CIFeR)) was shown to be feasible, acceptable, and reduced FCR in breast cancer patients in a pilot study. We now aim to explore the barriers and facilitators of implementing CIFeR within routine oncology practice in Australia. METHODS: This multicentre, single-arm Phase I/II implementation study recruited surgical, medical and radiation oncologists who treat women with early breast cancer. Participating clinicians completed online CIFeR training and were asked to use CIFeR for the next 6 months. Questionnaires were administered before (T0), immediately after (T1), then 3 (T2) and 6 months (T3) after training to assess confidence in addressing FCR and Proctor Implementation outcomes. The primary outcome was adoption at T2. Secondary outcomes were self-efficacy in FCR management, acceptability, feasibility, costs, barriers and facilitators of implementation. RESULTS: Fifty-two clinicians consented of whom 37 completed the CIFeR intervention training. Median age of participants was 41.5 (range 29-61), 73% were female and 51% were medical oncologists. The primary endpoint was met, with CIFeR adopted by 82%. Clinician intervention delivery took 7.4 min on average and was deemed acceptable, appropriate and feasible. Self-efficacy in managing FCR improved significantly across all domains (p < 0.001). Lack of time was the greatest barrier to routine CIFeR_2 implementation. CONCLUSIONS: A structured brief, low-cost clinician intervention to reduce FCR is useful, acceptable and improved self-efficacy with FCR management. Fear of cancer recurrence training should be incorporated into communication skills training of oncologists and surgeons. TRIAL REGISTRATION: Prospectively registered with the Australian New Zealand Clinical Trials Registry, ACTRN12621001697875. TRIAL SPONSOR: Chris O'Brien Lifehouse.

Staff- and service-level factors associated with organisational readiness to implement a clinical pathway for the identification, assessment, and management of anxiety and depression in adults with cancer.

BACKGROUND: Organisational readiness is recognised as a key factor impacting the successful translation of research findings into practice. Within psycho-oncology, measuring organisational readiness and understanding factors impacting organisational readiness is crucial as it is often challenging to implement evidence-based findings into routine cancer care. In this quantitative study, we examined the level of organisational readiness of cancer services preparing to implement a clinical pathway for the screening, assessment, and management of anxiety and depression in adult cancer patients (the ADAPT CP) within a cluster randomised controlled trial and sought to identify staff- and service-level factors associated with organisational readiness. METHODS: Multidisciplinary staff across 12 Australian cancer services were identified. Their perceptions of their services' readiness to implement the ADAPT CP in the cancer stream or treatment modality selected within their service was assessed prior to implementation using the Organizational Readiness for Implementing Change scale. Data collection included staff demographic and professional characteristics, and their perception of the ADAPT CP using a set of 13 study-specific survey items. Service characteristics were captured using a site profile audit form and workflows during site engagement. RESULTS: Fourteen staff- and service-level factors were identified as potentially impacting organisational readiness. To identify factors that best explained organisational readiness, separate univariate analyses were conducted for each factor, followed by a backward elimination regression. Compared to services that implemented the ADAPT CP in one treatment modality, those opting for four treatment modalities had significantly higher organisational readiness scores. Staff in administrative/technical support/non-clinical roles had significantly higher organisational readiness scores compared to psychosocial staff. Higher organisational readiness scores were also significantly related to more positive perceptions of the ADAPT CP. CONCLUSIONS: Readiness to implement an anxiety and depression clinical pathway within 12 oncology services was high. This may be attributed to the extensive engagement with services prior to implementation. The factors associated with organisational readiness highlight the importance of ensuring adequate resourcing and supporting staff to implement change, effectively communicating the value of the change, and taking a whole-of-service approach to implementing the change. Future longitudinal studies may identify factors associated with ongoing readiness and engagement prior to implementation. TRIAL REGISTRATION: The ADAPT RCT was registered prospectively with the ANZCTR on 22/03/2017. Trial ID ACTRN12617000411347. https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=372486&isReview=true .

Protocol of an implementation study of a clinician intervention to reduce fear of recurrence in cancer survivors (CIFeR_2 implementation study).

BACKGROUND: Fear of cancer recurrence (FCR) affects 50-70% of cancer survivors with 30% reporting an unmet need for help with managing FCR. Patients indicate desire to discuss FCR with clinicians, however clinicians indicate discomfort with managing FCR and no formal educational interventions on how to discuss FCR or worry exists for oncology clinicians. Our team developed a novel clinician-driven brief education intervention to help patients manage FCR (the Clinician Intervention to Reduce Fear of Recurrence (CIFeR) intervention). In earlier work, we demonstrated the feasibility, acceptability, and efficacy of CIFeR in reducing FCR in breast cancer patients. We now aim to explore the barriers and facilitators to implementing this low-cost brief intervention within routine oncology practice in Australia. The primary objective is to assess the adoption of CIFeR in routine clinical practice. Secondary objectives are to identify the uptake and sustainability, perceived acceptability, feasibility, costs, barriers and facilitators of implementation of CIFeR in routine clinical practice, and to assess whether training in CIFeR increases clinicians' self-efficacy in managing FCR with their patients. METHODS: This multicentre, single-arm Phase I/II implementation study will recruit medical and radiation oncologists and oncology surgeons who treat women with early breast cancer. Participants will complete online CIFeR training. They will then be asked to use CIFeR with suitable patients for the next 6 months. Participants will complete questionnaires prior to, immediately after and 3 and 6 months after training to assess confidence addressing FCR, and 3 and 6 months after training to assess Proctor Implementation outcomes. At 6 months, they will also be asked to participate in a semi-structured telephone interview to elicit their feedback about barriers and facilitators to using CIFeR in routine clinical practice. DISCUSSION: This study will provide further data to support the routine use of an evidence-based, clinician-lead educational intervention to reduce FCR in breast cancer patients. Additionally, this study will identify any barriers and facilitators to implementing the CIFeR intervention in routine care and evidence for integration of FCR training into oncology communication skills education. TRIAL REGISTRATION: Prospectively registered with the Australian New Zealand Clinical Trials Registry, ACTRN12621001697875. TRIAL SPONSOR: Chris O'Brien Lifehouse. PROTOCOL VERSION: 2.6, Dated 28th February 2023.

Australian oncology health professionals' knowledge, perceptions, and clinical practice related to cancer-related cognitive impairment and utility of a factsheet.

PURPOSE: Cancer-related cognitive impairment (CRCI) can have debilitating effects on cancer survivors' quality of life. Despite this, patients often report a lack of information provided by health professionals (HPs) to assist with understanding and managing cognitive changes. This study aimed to explore Australian oncology HPs' understanding of and clinical practice related to CRCI including the use of a Cancer Council Australia CRCI factsheet. METHODS: Australian oncology HPs (medical oncologists, cancer nurses, and clinical psychologists) completed a questionnaire that assessed CRCI knowledge, prior to receiving the factsheet. Semi-structured interviews were conducted to explore their perceptions of CRCI and the factsheet. Interviews were recorded, transcribed, and analyzed using framework analysis to identify key themes. RESULTS: Questionnaires were completed by twenty-nine HPs. Most HPs had moderate to high knowledge of CRCI, yet low knowledge of the relationship between CRCI and cancer. Twenty-six (response rate 90%) HPs; medical oncologists (n = 7), cancer nurses (n = 12), and clinical psychologists (n = 7), consented to be interviewed. Three main themes were identified: (1) Is CRCI impact real or over-rated?; (2) If it is important, they will tell me: identifying and responding to CRCI in clinical practice; and (3) Using a factsheet in clinical practice. CONCLUSION: This study's multi-disciplinary exploration of Australian oncology HPs' perceptions of CRCI highlighted that health professional perceptions drive CRCI discussions with patients. Further education to support clinicians to discuss CRCI is required. Consideration of the barriers and facilitators within healthcare settings is important for successful integration of the factsheet into routine care.

Cancer-related cognitive impairment: a mixed methods evaluation of a standard factsheet.

PURPOSE: To understand the impact of cancer survivors accessing a standard factsheet regarding cancer-related cognitive impairment (CRCI), publicly available to the Australian public via Cancer Council Australia's websites. METHODS: Twenty-three cancer survivors completed a questionnaire assessing pre-factsheet knowledge of CRCI. Semi-structured interviews were conducted to explore participants' experiences of CRCI and perceptions of the factsheet. Interviews were analysed via thematic analysis using a framework approach. Finally, participants completed another questionnaire assessing post-factsheet change in knowledge of CRCI. RESULTS: Pre- and post-factsheet questionnaire change scores indicated increased knowledge and greater confidence about CRCI. Interview data resulted in five themes: generally positive perceptions of the factsheet's layout and wording; survivors, regardless of treatments received, experienced CRCI symptoms, with some having strong negative emotional responses to their symptoms; perceptions of the factsheet's strategies to manage CRCI ranged from relevant and useful, to impractical or unrealistic if symptoms were too severe; interactions with healthcare system influenced survivors' perceptions of help-seeking, with negative healthcare experiences a major barrier; and generally positive impacts of the factsheet, with survivors praising the factsheet's ability to validate the CRCI experience, increase CRCI knowledge, influence health beliefs, and prompt help-seeking. CONCLUSION: The factsheet presentation and wording were acceptable to participants. Its ability to normalise and raise awareness for CRCI validated participants' symptoms. The factsheet's potential as a first-line intervention in a stepped-care approach was identified, with participants finding the suggested self-management strategies practical. The factsheet may overcome barriers to self-reporting by encouraging patients to talk with HCPs about CRCI.

Staff perspectives on the feasibility of a clinical pathway for anxiety and depression in cancer care, and mid-implementation adaptations.

BACKGROUND: Clinical pathways (CPs) are intended to standardise and improve care but do not always produce positive outcomes, possibly because they were not adapted to suit the specific context in which they were enacted. This qualitative study aimed to explore staff perspectives of implementation of a CP for routine screening, assessment, referral and management of anxiety and depression (the ADAPT CP) for patients with cancer, focussing on perceived feasibility of the CP and negotiated adaptations made during the implementation phase. METHODS: The ADAPT CP was implemented in 12 urban and regional oncology services in Australia. Services were randomised to receive core versus enhanced implementation strategies. Core sites received support until implementation commencement and could access progress reports. Enhanced sites received proactive, ongoing support during the 12-month implementation. Purposively selected staff were interviewed prior to implementation (n = 88) and 6 months later, half-way through the implementation period (n = 89). Monthly meetings with lead multi-disciplinary teams at the eight enhanced sites were recorded. Data were thematically analysed. RESULTS: Six overarching themes were identified: ADAPT is of high value; timing for introducing the CP and screening is difficult; online screening is challenging; a burden too much; no-one to refer patients to; and micro-logistics are key. While early screening was deemed desirable, diverse barriers meant this was complex, with adaptations made to time and screening location. Online screening prompted by email, seen as time-saving and efficient, also proved unsuccessful in some services, with adaptations made to in-clinic or phone screening, or repeated email reminders. Staff negative attitudes to ADAPT, time constraints, and perceived poor fit of ADAPT to work roles and flows, all impacted implementation, with key tasks often devolving to a few key individuals. Nevertheless, services remained committed to the ADAPT CP, and worked hard to create, review and adapt strategies to address challenges to optimise success. CONCLUSIONS: This study demonstrates the interactive nature of health service change, with staff actively engaging with, forming views on, and problem-solving adaptations of the ADAPT CP to overcome barriers. Obtaining staff feedback is critical to ensure health service change is sustainable, meaningful and achieves its promise of improving patient outcomes. TRIAL REGISTRATION: The study was registered prospectively with the ANZCTR on 22/3/2017. Trial ID ACTRN12617000411347.

Acceptability and appropriateness of a clinical pathway for managing anxiety and depression in cancer patients: a mixed methods study of staff perspectives.

BACKGROUND: Clinical pathways (CPs) can improve health outcomes, but to be sustainable, must be deemed acceptable and appropriate by staff. A CP for screening and management of anxiety and depression in cancer patients (the ADAPT CP) was implemented in 12 Australian oncology services for 12 months, within a cluster randomised controlled trial of core versus enhanced implementation strategies. This paper compares staff-perceived acceptability and appropriateness of the ADAPT CP across study arms. METHODS: Multi-disciplinary lead teams at each service tailored, planned, championed and implemented the CP. Staff at participating services, purposively selected for diversity, completed a survey and participated in an interview prior to implementation (T0), and at midpoint (6 months: T1) and end (12 months: T2) of implementation. Interviews were recorded, transcribed and thematically analysed. RESULTS: Seven metropolitan and 5 regional services participated. Questionnaires were completed by 106, 58 and 57 staff at T0, T1 and T2 respectively. Eighty-eight staff consented to be interviewed at T0, with 89 and 76 at T1 and T2 (response rates 70%, 66% and 57%, respectively). Acceptability/appropriateness, on the quantitative measure, was high at T0 (mean of 31/35) and remained at that level throughout the study, with no differences between staff from core versus enhanced services. Perceived burden was relatively low (mean of 11/20) with no change over time. Lowest scores and greatest variability pertained to perceived impact on workload, time and cost. Four major themes were identified: 1) Mental health is an important issue which ADAPT addresses; 2) ADAPT helps staff deliver best care, and reduces staff stress; 3) ADAPT is fit for purpose, for both cancer care services and patients; 4) ADAPT: a catalyst for change. Opposing viewpoints are outlined. CONCLUSIONS: This study demonstrated high staff-perceived acceptability and appropriateness of the ADAPT CP with regards to its focus, evidence-base, utility to staff and patients, and ability to create change. However, concerns remained regarding burden on staff and time commitment. Strategies from a policy and managerial level will likely be required to overcome the latter issues. TRIAL REGISTRATION: The study was registered prospectively with the ANZCTR on 22/3/2017. Trial ID ACTRN12617000411347. https://www.anzctr.org.au/ .

Fidelity and acceptability of implementation strategies developed for adherence to a clinical pathway for screening, assessment and management of anxiety and depression in adults with cancer.

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.

Effect of core versus enhanced implementation strategies on adherence to a clinical pathway for managing anxiety and depression in cancer patients in routine care: a cluster randomised controlled trial.

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 ).