ASCOT: Lifestyle study for cancer survivors
| ISRCTN | ISRCTN17421871 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17421871 |
| Secondary identifying numbers | 17783 |
- Submission date
- 29/07/2015
- Registration date
- 29/07/2015
- Last edited
- 19/03/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
Contact information
Public
University of Leeds
Worsley Building
Level 10
Clarendon Way
Woodhouse
Leeds
LS2 9JT
United Kingdom
 ORCID ID |
0000-0001-8287-9351 |
|---|---|
| Phone | +44 (0)113 3430741 |
| r.beeken@leeds.ac.uk |
Study information
| Study design | Both; Interventional and Observational; Design type: Process of Care, Cohort study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Advancing Survivorship after Cancer: Outcomes Trial |
| Study acronym | ASCOT |
| Study objectives | 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(s) | NRES Committee South Central - Oxford B, 05/12/2014, ref: 14/SC/1369; |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 13/02/2015 |
| Completion date | 31/08/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | 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 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 20/05/2015 |
| Date of final enrolment | 01/04/2019 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Chelmsford Essex
CM1 7ET
United Kingdom
Essex
SS16 5NL
United Kingdom
London
NW1 2PG
United Kingdom
Sponsor information
University/education
Gower Street
London
WC1E 6BT
England
United Kingdom
"ROR" |
https://ror.org/02jx3x895 |
|---|
Funders
Funder type
Charity
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- CR_UK, Cancer Research UK - London, CRUK
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/12/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| 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 plan | 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 23/11/2016 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
19/03/2024: Contact details updated. The intention to publish date was changed from 31/08/2023 to 31/12/2024.
21/09/2022: The following changes were made to the trial record:
1. The overall end date was changed from 01/09/2022 to 31/08/2023.
2. The intention to publish date was changed from 01/01/2023 to 31/08/2023.
14/03/2022: The following changes were made to the trial record:
1. The overall end date was changed from 01/06/2022 to 01/09/2022.
2. The intention to publish date was changed from 01/03/2022 to 01/01/2023.
04/10/2021: The following changes have been made:
1. The overall trial end date has been changed from 01/02/2022 to 01/06/2022.
2. The intention to publish date has been changed from 01/10/2021 to 01/03/2022.
13/04/2021: The following changes were made to the trial record:
1. The overall trial end date was changed from 01/11/2021 to 01/02/2022.
2. The intention to publish date was changed from 01/04/2021 to 01/10/2021.
18/12/2020: The following changes were made to the trial record:
1. The recruitment end date was changed from 03/11/2017 to 01/04/2019.
2. The overall trial end date was changed from 03/11/2020 to 01/11/2021.
3. The intention to publish date was changed from 01/06/2018 to 01/04/2021.
4. Total final enrolment and trial website added.
5. The inclusion criteria and contact details were updated.
10/01/2018: The following changes were made:
1. Recruitment end date was changed from 30/09/2016 to 03/11/2017.
2. Overall trial end date was changed from 31/03/2017 to 03/11/2020.
3. Intention to publish date was changed from 30/06/2017 to 01/06/2018.
4. IPD sharing statement was added.
5. Outcome measures were updated.
30/11/2016: Publication reference added.
The registration of this study was initiated in 13/11/2014 and finalised on 29/07/2015. Following the prospective submission on 23/07/2015, there were no changes to the protocol prior to registration being finalised. The recruitment started on 20/05/2015, after initiation of public registration.
