Experiences of using a supported digital intervention for cancer survivors in primary care: a qualitative process evaluation.

BACKGROUND: Increasing healthy behaviours (e.g. physical activity) can improve cancer survivors' quality of life. Renewed is a digital intervention developed to provide behaviour change advice with brief healthcare practitioner support. A three-arm randomised controlled trial (Renewed, Renewed with support or a control condition) suggested that prostate cancer survivors in the supported arm had slightly greater estimates of improvements in quality of life compared to other cancer survivors. This study explored participants' experiences using Renewed to understand how it might have worked and why it might have provided greater benefit for prostate cancer survivors and those in the supported arm. METHODS: Thirty-three semi-structured telephone interviews with cancer survivors' (breast, colorectal, prostate) from the Renewed trial explored their experiences of using Renewed and their perceptions of the intervention. Data were analysed using inductive thematic analysis. RESULTS: Some participants only used Renewed modestly but still made behaviour changes. Barriers to using Renewed included low perceived need, joining the study to advance scientific knowledge or 'to give back', or due to perceived availability of support in their existing social networks. Prostate cancer survivors reported less social support outside of Renewed compared to participants with other cancers. CONCLUSION: Renewed may support healthy behaviour changes among cancer survivors even with limited use. Interventions targetting individuals who lack social support may be beneficial. IMPLICATIONS FOR CANCER SURVIVORS: Cancer survivors' experiences may inform the development of digital interventions to better serve this population.

A multicentre randomised controlled trial of a guided self-help cognitive behavioural therapy to MANage the impact of hot flushes and night sweats in patients with prostate CANcer undergoing androgen deprivation therapy (MANCAN2).

BACKGROUND: Androgen deprivation therapy (ADT) is prescribed to almost half of all men diagnosed with prostate cancer. Although ADT is effective treatment, with virtually all men with advanced disease showing initial clinical response, it is associated with troublesome side effects including hot flushes and night sweats (HFNS). HFNS can be both frequent and severe and can have a significant impact on quality of life (QoL). They can occasionally be so debilitating that patients stop ADT altogether, despite the increased risk of disease relapse or death. Previous research has found that guided self-help cognitive behavioural therapy (CBT) can be effective in reducing HFNS due to ADT when delivered by a clinical psychologist. MANCAN2 aims test whether we can train the existing NHS Prostate Cancer Nurse Specialist (CNS) team to deliver guided self-help CBT and whether it is effective in reducing the impact of HFNS in men undergoing ADT. METHODS: MANCAN2 is a phase III multicentre randomised controlled trial and process evaluation. Between 144 and 196 men with prostate cancer who are currently receiving ADT and are experiencing problematic HFNS will be individually randomised in a 1:1 ratio in groups of 6-8 participants to either treatment as usual (TAU) or participation in the guided self-help CBT intervention plus TAU. A process evaluation using the normalisation process theory (NPT) framework will be conducted, to understand the CNS team's experiences of delivering the intervention and to establish the key influencers to its implementation as a routine practice service. Fidelity of implementation of the intervention will be conducted by expert assessment. The cost-effectiveness of the intervention and participant adherence to the trial intervention will also be assessed. DISCUSSION: MANCAN2 will advance the program of work already conducted in development of management strategies for HFNS. This research will determine whether the severity of ADT-induced HFNS in men with prostate cancer can be reduced by a guided self-help CBT intervention, delivered by the existing NHS prostate cancer CNS team, within a multicentre study. The emphasis on this existing team, if successful, should facilitate translation through to implementation in routine practice. TRIAL REGISTRATION: ISRCTN reference 58720120 . Registered 13 December 2022.

A randomised controlled trial of a digital intervention (Renewed) to support symptom management, wellbeing and quality of life in cancer survivors.

BACKGROUND: Many cancer survivors following primary treatment have prolonged poor quality of life. AIM: To determine the effectiveness of a bespoke digital intervention to support cancer survivors. DESIGN: Pragmatic parallel open randomised trial. SETTING: UK general practices. METHODS: People having finished primary treatment (<= 10 years previously) for colo-rectal, breast or prostate cancers, with European-Organization-for-Research-and-Treatment-of-Cancer QLQ-C30 score <85, were randomised by online software to: 1)detailed 'generic' digital NHS support ('LiveWell';n=906), 2) a bespoke complex digital intervention ('Renewed';n=903) addressing symptom management, physical activity, diet, weight loss, distress, or 3) 'Renewed-with-support' (n=903): 'Renewed' with additional brief email and telephone support. RESULTS: Mixed linear regression provided estimates of the differences between each intervention group and generic advice: at 6 months (primary time point: n's respectively 806;749;705) all groups improved, with no significant between-group differences for EORTC QLQ-C30, but global health improved more in both intervention groups. By 12 months there were: small improvements in EORTC QLQ-C30 for Renewed-with-support (versus generic advice: 1.42, 95% CIs 0.33-2.51); both groups improved global health (12 months: renewed: 3.06, 1.39-4.74; renewed-with-support: 2.78, 1.08-4.48), dyspnoea, constipation, and enablement, and lower NHS costs (generic advice £265: in comparison respectively £141 (153-128) and £77 (90-65) lower); and for Renewed-with-support improvement in several other symptom subscales. No harms were identified. CONCLUSION: Cancer survivors quality of life improved with detailed generic online support. Robustly developed bespoke digital support provides limited additional short term benefit, but additional longer term improvement in global health enablement and symptom management, with substantially lower NHS costs.

A feasibility study of a psycho-educational support intervention for men with prostate cancer on active surveillance.

BACKGROUND: PROACTIVE is a psycho-educational support intervention for prostate cancer patients managed on Active Surveillance. PROACTIVE is composed of two interdependent components: group workshops and internet-delivered information modules. AIMS: We conducted a feasibility study to determine the practicality of delivering PROACTIVE at two prostate cancer centres. METHODS AND RESULTS: The feasibility study was a mixed-methods randomized parallel-group exploratory trial. Participants were randomised using a ratio of 3:1 PROACTIVE group to treatment as usual. Qualitative semi-structured interviews and quantitative measures were completed at baseline, intervention completion (week 6), and at 6-month follow-up. Interview transcripts were analysed thematically using Framework analysis. Descriptive statistics were used to examine recruitment and retention rates and changing trends in outcome measures. Most aspects of the research design and PROACTIVE intervention were acceptable to those participating in the study. In particular, participants valued the opportunity to share and discuss experiences with other prostate cancer patients on Active Surveillance and receive detailed authoritative information. However, three issues were identified: (a) a low response rate (13 participants recruited, response rate 16%), (b) low utilisation of internet delivered information modules, (c) self-perceived low levels of anxiety amongst participants with the majority perceiving their cancer as not impacting on their day-to-day life or causing anxiety. CONCLUSIONS: Due to these significant research design issues, it is not recommended PROACTIVE be evaluated in a large-scale randomised controlled trial. Further research is required to explore the impact of Active Surveillance on anxiety amongst men with localized prostate cancer managed by Active Surveillance.

Developing a digital intervention for cancer survivors: an evidence-, theory- and person-based approach.

This paper illustrates a rigorous approach to developing digital interventions using an evidence-, theory- and person-based approach. Intervention planning included a rapid scoping review that identified cancer survivors' needs, including barriers and facilitators to intervention success. Review evidence (N = 49 papers) informed the intervention's Guiding Principles, theory-based behavioural analysis and logic model. The intervention was optimised based on feedback on a prototype intervention through interviews (N = 96) with cancer survivors and focus groups with NHS staff and cancer charity workers (N = 31). Interviews with cancer survivors highlighted barriers to engagement, such as concerns about physical activity worsening fatigue. Focus groups highlighted concerns about support appointment length and how to support distressed participants. Feedback informed intervention modifications, to maximise acceptability, feasibility and likelihood of behaviour change. Our systematic method for understanding user views enabled us to anticipate and address important barriers to engagement. This methodology may be useful to others developing digital interventions.

Renewed: Protocol for a randomised controlled trial of a digital intervention to support quality of life in cancer survivors.

INTRODUCTION: Low quality of life is common in cancer survivors. Increasing physical activity, improving diet, supporting psychological well-being and weight loss can improve quality of life in several cancers and may limit relapse. The aim of the randomised controlled trial outlined in this protocol is to examine whether a digital intervention (Renewed), with or without human support, can improve quality of life in cancer survivors. Renewed provides support for increasing physical activity, managing difficult emotions, eating a healthier diet and weight management. METHODS AND ANALYSIS: A randomised controlled trial is being conducted comparing usual care, access to Renewed or access to Renewed with brief human support. Cancer survivors who have had colorectal, breast or prostate cancer will be identified and invited through general practice searches and mail-outs. Participants are asked to complete baseline measures immediately after screening and will then be randomised to a study group; this is all completed on the Renewed website. The primary outcome is quality of life measured by the European Organization for Research and Treatment of Cancer QLQ-c30. Secondary outcomes include anxiety and depression, fear of cancer recurrence, general well-being, enablement and items relating to costs for a health economics analysis. Process measures include perceptions of human support, intervention usage and satisfaction, and adherence to behavioural changes. Qualitative process evaluations will be conducted with patients and healthcare staff providing support. ETHICS AND DISSEMINATION: The trial has been approved by the NHS Research Ethics Committee (Reference 18/NW/0013). The results of this trial will be published in peer-reviewed journals and through conference presentations. TRIAL REGISTRATION NUMBER: ISRCTN96374224; Pre-results.

'Calling executives and clinicians to account': user involvement in commissioning cancer services.

BACKGROUND: English NHS guidance emphasizes the importance of involving users in commissioning cancer services. There has been considerable previous research on involving users in service improvement, but not on involvement in commissioning cancer services. OBJECTIVE: To identify how users were involved as local cancer service commissioning projects sought to implement good practice and what has been learned. DESIGN: Participatory evaluation with four qualitative case studies based on semi-structured interviews with project stakeholders, observation and documentary analysis. Users were involved in every stage from design to analysis and reporting. SETTING AND PARTICIPANTS: Four English cancer network user involvement in commissioning projects, with 22 stakeholders interviewed. RESULTS: Thematic analysis identified nine themes: initial involvement, preparation for the role, ability to exercise voice, consistency and continuity, where decisions are made, closing the feedback loop, assessing impact, value of experience and diversity. DISCUSSION: Our findings on the impact of user involvement in commissioning cancer services are consistent with other findings on user involvement in service improvement, but highlight the specific issues for involvement in commissioning. Key points include the different perspectives users and professionals may have on the impact of user involvement in commissioning, the time necessary for meaningful involvement, the importance of involving users from the beginning and the value of senior management and PPI facilitator support and training. CONCLUSIONS: Users can play an important role in commissioning cancer services, but their ability to do so is contingent on resources being available to support them.