Condition category
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status

Contact information



Primary contact

Prof Annie Anderson


Contact details

Centre for Research into Cancer Prevention and Screening
Cancer Division
Medical Research Institute
Mailbox 7
Ninewells Hospital and Medical School
United Kingdom

Additional identifiers

EudraCT number number

Protocol/serial number

TreatWELL study protocol V2 13.12.13

Study information

Scientific title

TreatWELL - A feasibility study to assess the delivery of a lifestyle intervention for colorectal cancer patients undergoing potentially curative treatment



Study hypothesis

That it is feasible to deliver a lifestyle intervention (smoking cessation, increased physical activity, alcohol reduction and a healthy diet) to patients undergoing potentially curative treatment, initiated at diagnosis of colorectal (bowel) cancer throughout the pre-surgery, post-surgery and recovery period.

Ethics approval

East of Scotland Research Ethics Service,17/12/2013, ref.13/ES/0153

Study design

Non-randomised feasibility trial to inform the feasibility of undertaking a future randomised controlled trial

Primary study design


Secondary study design

Non randomised controlled trial

Trial setting


Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Bowel cancer / Diagnosis of Bowel Cancer / Lifestyle intervention


Three 1-hour counselling sessions with a lifestyle counsellor. These will take place during three phases of the study; phase-1 pre-surgery, phase-2 surgical recovery and phase-3 post-surgery / adjuvant therapy recovery. The counselling sessions will be tailored to phase and include advice and support on smoking cessation, increased physical activity, alcohol reduction and a healthy diet and body weight. The face-to-face sessions are designed to be interactive and will include a 10 minute walk and talk session. Fortnightly telephone calls will also be made to the participants and the intervention will be supported with written materials. Behavioural techniques include goal setting, action planning (implementation intentions), coping planning and self-monitoring.

Intervention type



Not Applicable

Drug names

Primary outcome measure

1. Uptake of intervention programme (recruitment levels, time from diagnosis to intervention). This will be monitored through accurate recording of the screening and recruitment of patients diagnosed with colorectal cancer over a 5 month period.
2. Delivery of the intervention (Can the programme be implemented in the NHS setting? What is the length of time in each phase? Fidelity to protocol). This will be monitored by accurate recording of length of time each participant spends in each phase of the study and by acceptability interviews at the end of phases 2 and 3 with study staff and participants.
3. Patient responses and evaluation measures (To what extent can patients achieve their goals? Can evaluation measures be undertaken successfully? Retention rate). Goal setting and goal achievement will be addressed and recorded at each contact between the lifestyle counsellors and participants (either face to face contact or telephone contact will be made every two weeks). The research nurse will take note of any evaluation measures that are not undertaken and the reason why. Retention rate will be assessed by keeping accurate records of how long each participant spends in the study and whether any participants withdraw from the study before the end.
4. Patients' views (acceptability of programme, what factors do patients think influence adherence?) This will be monitored using exit questionnaires and acceptability interviews at the end of phases 2 and 3 of the study.
5. Intervention costs. Everything that is spent during the study will be carefully recorded and analysed.

Primary outcome measures will be measured at baseline and at the end of each phase of the study (phase-1 pre-surgery, phase-2 surgical recovery and phase-3 post-surgery / adjuvant therapy recovery).

Secondary outcome measures

1. Self-reported smoking, self-reported alcohol intake, physical activity (Scottish physical activity questionnaire and 6 minute walk test)
2. Dietary measures (DINE questionnaire)
3. Physiological measures (height, weight, waist circumference, skin fold thickness)
4. Fatigue (questionnaire)
5. Bowel function (questionnaire)
6. Quality of life (questionnaire)

Secondary outcome measures will be measured at baseline and at the end of each phase of the study (phase-1 pre-surgery, phase-2 surgical recovery and phase-3 post-surgery / adjuvant therapy recovery).

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

1. Adults (18 years and over)
2. Capable of giving informed consent
3. With stage I to III colorectal cancer
4. Eligible for potentially curative treatment (must be fit for major surgery)

Participant type


Age group




Target number of participants


Participant exclusion criteria

1. Severe cognitive impairment
2. Not fit for major surgery

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Centre for Research into Cancer Prevention and Screening
United Kingdom

Sponsor information


Tayside Medical Science Centre (UK)

Sponsor details

TASC R&D Office
Ninewells Hospital and Medical School
Residency block Level 3
George Pirie Way
United Kingdom
+44 1382740125

Sponsor type

Research organisation



Funder type


Funder name

Chief Scientist Office (UK), Ref. CZH/4/939

Alternative name(s)


Funding Body Type

government organisation

Funding Body Subtype

Local government


United Kingdom

Results and Publications

Publication and dissemination plan

Publication is currently in prep for BMJ open – submission by end of september. The work has been presented at UKSBM conference.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are/will be available upon request from Professor Annie Anderson all data collected (including qualitative), available now.

Intention to publish date


Participant level data

Not provided at time of registration

Basic results (scientific)

Publication list

2018 results in:

Publication citations

Additional files

Editorial Notes

29/03/2019: Cancer Research UK lay results summary link added to Results (plain English). 20/02/2019: Publication reference added. 11/08/2017: Added ORCID. Participant level data sharing plan. Participant information sheet has been uploaded. Overall trial end date has been updated from 30/04/2015 to 30/06/2015. Recruitment dates have been updated from 01/12/2013-31/10/2014 to 01/04/2014 -31/10/2014. Protocol V1 14 November 2013 has been uploaded. 09/08/2017: No publications found in PubMed, verifying study status with principal investigator.