Plain English Summary
Trial website
Contact information
Type
Public
Primary contact
Dr Pippa Lally
ORCID ID
http://orcid.org/0000-0002-4847-4163
Contact details
Energy Balance & Cancer
and Obesity Research Groups
Research Department of Behavioural Science and Health
University College London
London
WC1E 6BT
United Kingdom
+44 (0)2076791961
p.lally@ucl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
17783
Study information
Scientific title
Advancing Survivorship after Cancer: Outcomes Trial
Acronym
ASCOT
Study hypothesis
The Advancing Survival in Cancer Outcomes Trial (ASCOT) is aimed helping cancer patients adhere to the World Cancer Research Fund (WCRF) guidelines for a healthy lifestyle. ASCOT involves a:
1. Lifestyle survey
2. Habit based lifestyle intervention
The ASCOT survey will be sent to patients diagnosed with breast, prostate or colorectal cancer in 2012/2013 in an NHS Trust in London or Essex. The survey contains questions on lifestyle (diet, physical activity, alcohol, smoking, sleep and weight), psychosocial outcomes (fatigue and quality of life) and information on advice received, and desire for lifestyle advice (timing, format, type). Patients will also be given the opportunity to participant in the ASCOT trial. The ASCOT trial is an individually randomised controlled trial examining whether a leaflet (with phone consultation and website) that provides the WCRF lifestyle recommendations for lifestyle for cancer survivors, using habit theory to help patients find simple ways to incorporate healthy habits into their routines, can improve lifestyle.
Ethics approval
NRES Committee South Central - Oxford B, 05/12/2014, ref: 14/SC/1369;
Study design
Both; Interventional and Observational; Design type: Process of Care, Cohort study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Topic: Cancer; Subtopic: All Cancers/Misc Sites; Disease: All
Intervention
ASCOT is a lifestyle intervention (a leaflet developed in consultation with clinicians and patients, a phone consultation and a website) aimed at helping cancer patients adhere to the World Cancer Research Fund lifestyle guidelines for cancer survivors. ASCOT uses habit theory to incorporate simple habits and tips to facilitate behaviour change.
Follow Up Length: 6 month(s)
Study Entry : Single Randomisation only
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
Current primary outcome measures (as of 10/01/2018)
Composite health behaviour risk index; Timepoint(s): 0, 3, 6 and 24 months
Previous primary outcome measures
Composite health behaviour risk index; Timepoint(s): 0, 3 and 6 months
Secondary outcome measures
Current secondary outcome measures (as of 10/01/2018)
1. Alcohol (AUDIT C questionnaire); Timepoint(s): 0, 3, 6 and 24 months
2. Dietary intake (24 hour dietary recall phone calls); Timepoint(s): 0, 3, 6 and 24 months
3. Physical activity (pedometer and questionnaire); Timepoint(s): 0, 3, 6 and 24 months
4. Quality of Life (EQ-5D-5L); Timepoint(s): 0, 3, 6 and 24 months
5. Sleep (questionnaire); Timepoint(s): 0, 3, 6 and 24 months
6. Smoking status (questionnaire); Timepoint(s): 0, 3, 6 and 24 months
Previous secondary outcome measures
1. Alcohol (AUDIT C questionnaire); Timepoint(s): 0, 3 and 6 months
2. Dietary intake (24 hour dietary recall phone calls); Timepoint(s): 0, 3 and 6 months
3. Physical activity (pedometer and questionnaire); Timepoint(s): 0, 3 and 6 months
4. Quality of Life (EQ-5D-5L); Timepoint(s): 0, 3 and 6 months
5. Sleep (questionnaire); Timepoint(s): 0, 3 and 6 months
6. Smoking status (questionnaire); Timepoint(s): 0, 3 and 6 months
Overall trial start date
13/02/2015
Overall trial end date
01/11/2021
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Current inclusion criteria as of 18/12/2020:
ASCOT patient survey:
All individuals diagnosed with breast, prostate or colorectal cancer in 2012-2015 at an NHS trust in London or Essex.
ASCOT pilot trial:
1. Adults aged at least18 years (no upper age limit)
2. Individuals diagnosed with non-metastatic breast, prostate or colorectal cancer in 2012-2015
3. Individuals not receiving active anti-cancer treatment (except for those oral anti-cancer treatments taken at home who can be included)
4. Individuals who are able to understand spoken and written English
Previous inclusion criteria:
ASCOT patient survey:
All individuals diagnosed with breast, prostate or colorectal cancer in 2012 or 2013 at an NHS trust in London or Essex.
ASCOT pilot trial:
1. Adults aged at least18 years (no upper age limit)
2. Individuals diagnosed with non-metastatic breast, prostate or colorectal cancer in 2012 or 2013
3. Individuals not receiving active anti-cancer treatment (except for those oral anti-cancer treatments taken at home who can be included)
4. Individuals who are able to understand spoken and written English
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 5000; UK Sample Size: 5000; Description: We will recruit up to 5000 for the cohort study. We will aim to recruit up to 950 patients into the trial. Based on previous lifestyle trials using a composite score we aim to detect a modest increased in risk index of 0.2 standard deviations at 3 months, and with 80% power and 5% two sided statistical significance we will required around 350 participants in each group.
Total final enrolment
1348
Participant exclusion criteria
ASCOT pilot trial:
1. Individuals with metastatic disease
2. Individuals on active anti-cancer treatment requiring hospital admission
3. Individuals with severe cognitive impairment
Recruitment start date
20/05/2015
Recruitment end date
01/04/2019
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Broomfield Hospital
Court Road
Chelmsford Essex
CM1 7ET
United Kingdom
Trial participating centre
Basildon Hospital
Nethermayne
Essex
SS16 5NL
United Kingdom
Trial participating centre
University College London Hospital
250 Euston Road
London
NW1 2PG
United Kingdom
Funders
Funder type
Charity
Funder name
Cancer Research UK
Alternative name(s)
CRUK
Funding Body Type
private sector organisation
Funding Body Subtype
Other non-profit organizations
Location
United Kingdom
Results and Publications
Publication and dissemination plan
The results of the trial will be disseminated in relevant scientific conferences and meetings. The results will also be written up as paper publications and submitted to scientific, peer reviewed journals. This is planned for the first half of 2018.
IPD sharing statement: We will not be sharing participant level data as participants have not consented to this, and it would therefore be against data protection legislation. The data will be held at UCL on a data safehaven which uses a walled garden approach to secure data storage. We may share anonymised data after our primary data are published, but only if formally requested so we can control the nature of the analyses.
Intention to publish date
01/04/2021
Participant level data
Not expected to be available
Basic results (scientific)
Publication list
2016 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/27881518