Contact information
Type
Scientific
Primary contact
Prof Annie Anderson
ORCID ID
http://orcid.org/0000-0002-0047-4500
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
30/06/2015
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
01/04/2014
Recruitment end date
31/10/2014
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
+44 1382740125
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
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 a.s.anderson@dundee.ac.uk all data collected (including qualitative), available now.
Intention to publish date
30/09/2017
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
Publication citations
Additional files
- ISRCTN52345929_PIS_V3_18Dec13.pdf Uploaded 11/08/2017
- ISRCTN52345929_PROTOCOL_V1_14Nov13.pdf Uploaded protocol V1 14 November 2013 on 11/08/2017