Digital intervention to support cancer survivors: the CLASP research programme

Background: there are increasing numbers of cancer survivors who have finished their primary treatment, but whose quality of life remains consistently poor over years. There is limited evidence for pragmatic, brief interventions to support cancer survivors in primary care, where most patients are managed. Objective: to develop, trial and assess the effectiveness and cost-effectiveness of a digital intervention to support cancer survivors (named ‘Renewed’) designed to require minimal health service resources. Design: qualitative development of the intervention, then open randomised controlled trial, with a process analysis and health economic analysis. Setting: United Kingdom primary care Interventions: Development of the intervention: We systematically reviewed the relevant qualitative and quantitative literature to inform initial intervention planning, intervention content and design features of a digital intervention. This was followed by iterative development and optimisation of intervention content and the human support component – in qualitative studies of the views of cancer survivor, and of National Health Service, volunteer and charity workers. Main trial: Participants: people who had finished primary treatment for colorectal, breast or prostate cancer with lower quality of life (European Organization for Research and Treatment of Cancer QLQ-C30 score < 85) within the last 10 years. Participants were randomised to one of three groups: (1) ‘generic’ advice: detailed digital National Health Service support for healthier living (‘Living Well’), (2) a bespoke digital intervention (‘Renewed’) addressing symptom management, physical activity, diet, weight, distress and/or fear of recurrence, or (3) ‘Renewed’ plus support (additional brief support by e-mail, telephone, or face to face) Main outcome measures: Primary outcome: European Organization for Research and Treatment of Cancer QLQ-C30 (overall score). Secondary outcomes: subscales of European Organization for Research and Treatment of Cancer QLQ-C30 (global self-rated health; functional subscales; symptom subscales), EuroQol-5 Dimensions, five-level version, psychological measures and costs. Results: at the primary time point of 6 months, there were clinically important improvements in European Organization for Research and Treatment of Cancer QLQ-C30 score contrary to the expected trajectory of quality of life in this population, but with no evidence of differences between groups. By 12 months, the Renewed plus support group had continued to improve and was better than generic advice (1.42, 95% confidence intervals 0.33 to 2.51), with the largest differences in the prostate cancer subgroup. 13 of the 14 subscales also improved compared to generic advice, statistically significant for self-rated global health (Renewed: 3.06, 1.39 to 4.74; Renewed plus support: 2.78, 1.08 to 4.48), dyspnoea, constipation and enablement. For Renewed plus support, there were also statistically significant differences for physical, cognitive and emotional functioning and fatigue. Renewed and Renewed plus support were dominant given improved effectiveness combined with and lower mean primary care National Health Service costs per patient (respectively −£141, −153 to −128; −£77, −90 to −65). Limitations: of those sent invitation letters, 14% (7883/59,295) were assessed for eligibility and 35% (2732/7883) of those assessed were eligible and agreed to participate – which is normal with the ‘cold calling’ method of invitation. The digital intervention would not suit people who find technology or the internet difficult to access, but only 25% (2649/10,697) of those who gave reasons for declining did so due to lack of internet access. The extensive generic advice available to participants in the National Health Service limited the ability to assess the specific benefits of Renewed in the short term, but nevertheless longer-term benefit and lower National Health Service costs are likely to be achieved with the bespoke intervention. Conclusions: cancer survivors with lower quality of life given detailed generic online support improve significantly. Providing robustly developed, low-cost, bespoke digital support can provide further modest long-term improvements in enablement, symptom management and self-rated global health, with substantially lower National Health Service costs. Future work: the cost-effectiveness and benefits for symptom management on self-rated health suggest a more widespread implementation study should be undertaken. Trial registration: this trial is registered as Current Controlled Trials ISRCTN 96374224. Funding: this award was funded by the National Institute for Health and Care Research (NIHR) Programme Grants for Applied Research programme (NIHR award ref: RP-PG-0514-20001) and is published in full in Programme Grants for Applied Research; Vol. 14, No. 4. See the NIHR Funding and Awards website for further award information.