ASCOT: Lifestyle study for cancer survivors
Research type
Research Study
Full title
Advancing Survivorship after Cancer: Outcomes Trial (ASCOT)
IRAS ID
146804
Contact name
Rebecca Beeken
Contact email
Sponsor organisation
University College London Joint Research Office
Clinicaltrials.gov Identifier
Data Protection Registration Number, Z6364106/2014/07/18
Duration of Study in the UK
2 years, 6 months, 0 days
Research summary
This study has two parts to it and therefore two main aims. The first part (and aim) is to carry out a survey (ASCOT patient survey) to find out more about the current lifestyle behaviours (diet, physical activity, smoking and alcohol) of breast, prostate and colorectal cancer survivors and to identify their preferences for an intervention to help improve these behaviours. We will also assess participants well-being including quality of life, fatigue, sleep, happiness and social isolation.
The second part (and aim) is to develop and test a low intensity intervention (mailed materials and a phone call) designed to try and improve the lifestyle behaviours of these groups of cancer survivors. A pilot randomised controlled trial (ASCOT pilot trial) will be conducted to evaluate this intervention and to collect preliminary data on effectiveness. Effects of the intervention on a composite health behaviour risk index (CHI) at 3 and 6 months will be compared to usual care. Individual health behaviours will also be assessed. Changes in individual health behaviours (physical activity, sedentary behaviour, dietary intake, alcohol consumption and smoking status) will also be examined, and we will also explore whether any changes are maintained at 6 months. We will also conduct a process evaluation of the trial procedures
The ASCOT patient survey will be sent to patients diagnosed with breast, prostate or colorectal cancer in 2012 or 2013 at an NHS trust in London or Essex. It will contain questions on beliefs about lifestyle, current lifestyle behaviours, advice received about lifestyle behaviours since their cancer diagnosis, levels of enthusiasm for lifestyle advice and preferences for such advice with regard to timing and format. It will also contain some questions about their well-being including quality of life, fatigue, sleep, happiness and social isolation. The survey will provide rich and important data on the health behaviours of patients post diagnosis and their desire for lifestyle advice, as well as giving an indication of what constitutes ‘usual care’ in terms of lifestyle advice. On the final page of the survey there will be an opportunity for them to leave their contact details if they are interested in finding out more about the ASCOT pilot trial. Those who leave their details and who meet the eligibility criteria (determined by their responses to the ASCOT patient survey) will be sent another letter inviting them to take part in the ASCOT pilot trial, a patient information sheet and consent form.
Patients who return their signed consent forms will be individually-randomised to receive the ASCOT intervention (in addition to usual care) or usual care only. Additional baseline measures of physical activity and diet will be taken (participants will be mailed a pedometer to wear for a week and required to give two 24 hour telephone-based dietary recalls). Participants will then receive the ASCOT intervention or usual care. The intervention will involve printed materials, formulated using current health behaviour change theory, and a telephone consultation. Measures will be repeated at 3 and 6 months.
All aspects of the study, including the 6 month trial and recruitment, will take 30 months.
REC name
South Central - Oxford B Research Ethics Committee
REC reference
14/SC/1369
Date of REC Opinion
5 Dec 2014
REC opinion
Further Information Favourable Opinion