Title: Advancing survival cancer outcomes trial (ASCOT); long-term follow-up
Funder: Cancer Research UK

Abstract: Background Lifestyle factors (diet, physical activity, smoking, alcohol) are associated with outcomes after cancer diagnosis. CRUK’s prevention strategy has identified a need to design, rigorously evaluate and implement behaviour change interventions for secondary prevention. The CRUK funded Advancing Survival Cancer Outcomes Trial (ASCOT) tested a novel ‘light touch’ theory-based intervention to improve health behaviours after a cancer diagnosis. 1152 breast, CRC and prostate cancer patients were randomised to receive this intervention or usual care, with promising results at 3 and 6 months. ASCOT was designed to be easily disseminable, and could become part of the end of treatment cancer care package. However, first there is a need to test whether the intervention can promote sustained changes in health behaviours over the longer term. Aims The primary purpose of the proposed research is to follow ASCOT participants up at 24 months to determine whether behaviour change is sustained. Secondary aims are to explore impact of the intervention on mortality, cancer events, comorbidity, primary care use, cost-effectiveness and test for improvements in other patient reported outcomes. Methods Health behaviours will be re-assessed at 24 months using identical measures to those used at baseline, 3 and 6 months; an objective measure of physical activity (Omron pedometers) and multiple-pass 24 hour dietary recall alongside validated questionnaires. Public Health England and the National Cancer Registration Service will provide registry data for consenting participants on cancer stage, treatments, hospital attendance, new second primaries/recurrence and mortality. Patients will complete validated patient-reported outcome measures and report comorbid conditions and primary care use via the Client Service Receipt Inventory. Ethical approval has been granted. How the results of this research will be used The transition from a trial to extended follow-up study offers a crucial opportunity to explore longer-term impacts of interventions, but such studies are lacking in the behavioural science and cancer context. This study would provide much needed evidence for sustained behaviour change following a brief health behaviour intervention among patients with a diagnosis of cancer. Cancer events analyses will be strictly exploratory but will provide novel data on the potential impacts of our intervention for cancer outcomes. Recommendations from the NHS Independent Cancer Taskforce suggest that all cancer patients should receive advice on physical activity, diet, smoking and alcohol as part of their care from 2020. Demonstrating the long-term efficacy and cost-effectiveness of ASCOT would support the implementation of our intervention within UK cancer care.

Lay abstract: Background Lifestyle factors (diet, physical activity, smoking, alcohol) are associated with outcomes after cancer diagnosis. CRUK’s prevention strategy has identified a need to design, rigorously evaluate and implement behaviour change interventions for secondary prevention. The CRUK funded Advancing Survival Cancer Outcomes Trial (ASCOT) tested a novel ‘light touch’ theory-based intervention to improve health behaviours after a cancer diagnosis. 1152 breast, CRC and prostate cancer patients were randomised to receive this intervention or usual care, with promising results at 3 and 6 months. ASCOT was designed to be easily disseminable, and could become part of the end of treatment cancer care package. However, first there is a need to test whether the intervention can promote sustained changes in health behaviours over the longer term. Aims The primary purpose of the proposed research is to follow ASCOT participants up at 24 months to determine whether behaviour change is sustained. Secondary aims are to explore impact of the intervention on mortality, cancer events, comorbidity, primary care use, cost-effectiveness and test for improvements in other patient reported outcomes. Methods Health behaviours will be re-assessed at 24 months using identical measures to those used at baseline, 3 and 6 months; an objective measure of physical activity (Omron pedometers) and multiple-pass 24 hour dietary recall alongside validated questionnaires. Public Health England and the National Cancer Registration Service will provide registry data for consenting participants on cancer stage, treatments, hospital attendance, new second primaries/recurrence and mortality. Patients will complete validated patient-reported outcome measures and report comorbid conditions and primary care use via the Client Service Receipt Inventory. Ethical approval has been granted. How the results of this research will be used The transition from a trial to extended follow-up study offers a crucial opportunity to explore longer-term impacts of interventions, but such studies are lacking in the behavioural science and cancer context. This study would provide much needed evidence for sustained behaviour change following a brief health behaviour intervention among patients with a diagnosis of cancer. Cancer events analyses will be strictly exploratory but will provide novel data on the potential impacts of our intervention for cancer outcomes. Recommendations from the NHS Independent Cancer Taskforce suggest that all cancer patients should receive advice on physical activity, diet, smoking and alcohol as part of their care from 2020. Demonstrating the long-term efficacy and cost-effectiveness of ASCOT would support the implementation of our intervention within UK cancer care.

Research activity codes: 3.1 PRIMARY PREVENTION INTERVENTIONS TO MODIFY BEHAVIOURS OR PROMOTE WELL-BEING;7.1 INDIVIDUAL CARE NEEDS;8.2 HEALTH AND WELFARE ECONOMICS
Health categories: CANCER AND NEOPLASMS