Condition category
Cancer
Date applied
03/04/2014
Date assigned
20/05/2014
Last edited
01/05/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Prof Annie Anderson

ORCID ID

Contact details

Centre for Research into Cancer Prevention and Screening
Cancer Division
Medical Research Institute
Mailbox 7
Ninewells Hospital and Medical School
Dundee
DD1 9SY
United Kingdom
-
a.s.anderson@dundee.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov 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

Acronym

TreatWELL

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

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Other

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

Condition

Bowel cancer / Diagnosis of Bowel Cancer / Lifestyle intervention

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

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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

01/12/2013

Overall trial end date

30/04/2015

Reason abandoned

Eligibility

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

Patient

Age group

Adult

Gender

Both

Target number of participants

35

Participant exclusion criteria

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

Recruitment start date

01/12/2013

Recruitment end date

30/04/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Centre for Research into Cancer Prevention and Screening
Dundee
DD1 9SY
United Kingdom

Sponsor information

Organisation

Tayside Medical Science Centre (UK)

Sponsor details

TASC R&D Office
Ninewells Hospital and Medical School
Residency block Level 3
George Pirie Way
Dundee
DD1 9SY
United Kingdom
-
f.nuritova@dundee.ac.uk

Sponsor type

Research organisation

Website

Funders

Funder type

Government

Funder name

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

Alternative name(s)

CSO

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes