Condition category
Cancer
Date applied
29/07/2015
Date assigned
29/07/2015
Last edited
30/11/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Contact information

Type

Public

Primary contact

Dr Maggie Heinrich

ORCID ID

Contact details

University College London
Gower Street
London
WC1E 6BT
United Kingdom

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 measures

Composite health behaviour risk index; Timepoint(s): 0, 3 and 6 months

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

31/03/2017

Reason abandoned

Eligibility

Participant 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.

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

30/09/2016

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

Sponsor information

Organisation

University College London Joint Research Office

Sponsor details

Gower Street
London
WC1E 6BT
United Kingdom

Sponsor type

University/education

Website

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

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 2017.

Intention to publish date

30/06/2017

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

2016 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/27881518

Publication citations

Additional files

Editorial Notes

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.