CLASP-Internal Pilot and Randomised Controlled Trial
Research type
Research Study
Full title
Cancer: Life Affirming Survivorship support in Primary care (CLASP) Programme-Internal Pilot and Randomised Controlled Trial
IRAS ID
238636
Contact name
Paul Little
Contact email
Sponsor organisation
Univeristy of Southampton
ISRCTN Number
ISRCTN96374224
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
There is currently an unmet need for tailored support in primary care for cancer survivors, to improve their quality of life. This study aims to evaluate Renewed Online - an online intervention offering lifestyle and wellbeing support for cancer survivors. This study, funded by NIHR, aims to evaluate the intervention for improving quality of life in cancer survivors, by conducting an initial feasibility study with a view to completing a randomised controlled trial later.
Renewed Online was developed using feedback from patients and healthcare professionals. It consists of modules for lifestyle (healthy eating for weight management, physical activity) and well-being (coping with emotional distress, reducing fatigue). Modules are personalised by cancer type and gender. By asking the participant questions the intervention will suggest parts of the website of most help to each individual, based on participant's answers, to help users make informed decisions about which parts they would like to try.
Potential participants, cancer survivors (breast, colon and prostate cancer) will be recruited through GP practices. They will be randomised into one of three groups – usual care, access to Renewed, access to Renewed with human support. Support will be provided by a nurse or HCA at the patient’s surgery, or a central support facilitator employed by the study team or support worker from a cancer charity, in the form of brief support sessions (in person, by phone or email). Participants with access to Renewed can use the intervention, as much as they like, over a 12 month period.
All participants will be asked to complete online questionnaires at 6 and 12 months, and interviews will be held with some participants and health care staff to seek feedback regarding the intervention.
The current project aims to evaluate the intervention for improving quality of life in cancer survivors by conducting a randomised controlled trial.REC name
North West - Greater Manchester West Research Ethics Committee
REC reference
18/NW/0013
Date of REC Opinion
17 Jan 2018
REC opinion
Favourable Opinion