Trial Name
CLASP (RENEWEDonline) - Cancer: Life Affirming Survivorship support in Primary care Programme
Description
The current study aims to evaluate an online intervention offering lifestyle and wellbeing support for cancer survivors, called Renewed. The intervention has been developed using feedback from patients and healthcare professionals and provides modules for lifestyle (healthy eating; weight management; physical activity) and well-being (coping with emotional distress; reducing fatigue). A questionnaire generates suggestions for parts of the websites which may be most helpful to each individual based on participant answers; the questionnaire is accessible throughout the intervention to help users to make informed decisions about which parts they would like to try. The current project aims to evaluate the intervention for improving quality of life in cancer survivors, by conducting a randomised controlled trial.
Objectives
Primary Objective:
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Does the web-based Renewed programme result in a difference in quality of life at 6-month follow-up compared to treatment as usual?
Secondary Objectives:
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Does the web-based Renewed programme result in a difference in quality of life at 12-month follow-up compared to treatment as usual?
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Does the web-based Renewed programme result in a difference in rates of survivorship at 6 months?
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Does the web-based Renewed programme result in a difference in well-being (including low mood and fear of cancer recurrence) at 6-month and 12-month follow-up?
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Does Renewed help to change behaviours which would reduce the risk of secondary cancers (e.g. improve diet, lose weight etc)?
Tertiary Objective:
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Qualitative exploration of patient and Supporter views and experiences of the online programme and human support, to identify any changes required for the main trial and to generate hypotheses regarding likely mechanisms of action.
Design
Patients will be randomised to one of three groups:
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Control.
Patients will receive brief advice about lifestyle and wellbeing with written materials;
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Web only.
As in (1 above) but with support from a practice nurse to use an Internet based Lifestyle and Wellbeing Package called Renewed;
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Web with flexible nurse support.
As in (2 above) but with extra guidance and support to increase the likely patient use of the self-help intervention. This will be provided flexibly by practice nurses to participants who request it.
Patients form all groups will be followed up for over 1 year to see if their quality of life improves and to identify what part of the intervention worked well for them and what could have worked better for them.
Status
Open to recruitment
Population
2500 participants
Contacts
Chief Investigators:
Prof Paul Little and Prof Lucy Yardley
Programme Manager:
Jane Barnett
Trial co-ordinator:
Megan Liddiard
Email:
[email protected]
CLASP Website