Summary of aims and rationale
There are 2 million cancer survivors in the UK and this figure is expected to increase over time as the population ages and survival rates increase.3 The UK also has one of the lowest cancer survival records among developed countries4 and quality of life is poor,5,6 with particularly high levels of psychological distress and fatigue.6 There is evidence showing that both lifestyle and psychological well-being interventions are likely to significantly improve quality of life,7–10 but most of these interventions have been intensive and impractical to implement in primary care, which is where most contact with cancer survivors takes place. It is plausible, based on our previous internet supported interventions, that relatively resource-light interventions using internet-based support in a primary care context could be effective and cost-effective.
The aim of this research programme was therefore to develop and evaluate an internet-supported intervention for lifestyle and well-being among cancer survivors in primary care, and to estimate its effectiveness and cost-effectiveness in enhancing quality of life in cancer survivors.
Summary of alterations to the programme’s original aims/design
The planned feasibility trial was carried out, but it was later decided (in agreement with the funder) that it should be considered as an internal pilot study, as no changes were made to the intervention and study procedures between the feasibility and main trials. This allowed for data collected during the internal pilot to be used as part of the main trial.
The original intended plan had been to only use practice nurses (PNs) to provide support for the ‘website plus human support’ arm of the trial. In the early stages of the programme, we realised that for later dissemination, it might be wise to explore the potential for cancer charities to provide some of the human support during the feasibility trial. This was explored before the feasibility trial but proved to be unfeasible as cancer charities could only commit to supporting a small number of participants, which would not be adequate for the fully powered trial. In the end, PNs took on this role as planned, but with Clinical Research Network (CRN) nurses also providing support when Primary Care practices were unable to provide it.
During the main trial, a disparity in recruiting equal numbers to each cancer type (breast, prostate, colorectal) was noticed, with numbers for colorectal cancer participants being particularly low. This was attributed partly to the difference in prevalence of each cancer type, but also it appeared that colorectal cancer is often not well labelled in patient notes, so it was harder to identify these patients in primary care. The authors agreed with NIHR National Institute for Health and Care Research and the steering committee a plan to carry on recruiting to the 2500 participants target rather than trying to get equal numbers in each group. When the target was close to being reached, recruitment numbers showed an over recruitment of breast cancer participants, slight under-recruitment of prostate cancer participants, and low recruitment of colorectal cancer participants. We agreed with NIHR and the steering committee to continue recruiting prostate and colorectal cancer participants until the target for prostate cancer participants was reached. A no cost extension was granted by the NIHR to continue recruitment and the target for prostate cancer participants was subsequently reached in March 2020.
A final change was that we allowed eligible secondary care sites to participate. Only one secondary site was used (in Wales, which was experiencing slow recruitment at the time) as staff there were eager to participate and were able to carry out medical note reviews.
Although promised in the protocol, the societal health economic analysis was not proceeded with due to lack of any suggestions in the qualitative work that patients made use of non NHS services.
Summary of research
We proposed four workstreams (WSs) (see Figure 1).
FIGURE 1 Research pathway diagram. (Figure not reproduced here; see the original article.)
The first workstream (WS1) consisted of reviewing the literature and intervention planning, focusing on identifying intervention content and design features.
Workstream 2 developed the interventions (the website only and website plus human support), using iterative qualitative research to ensure that they were viewed as acceptable and useful by cancer survivors and those who provided human support (NHS and cancer charity staff and volunteers).
Workstream 3 and WS4 carried out a fully powered randomised controlled trial (RCT) of the cost-effectiveness for health-related quality of life (HRQoL) over 1 year of the optimum method(s) of delivering the intervention compared with usual care, with an embedded quantitative and qualitative process analysis.