Study to assess the delivery of a lifestyle intervention for colorectal cancer patients undergoing potentially curative treatment

ISRCTN	ISRCTN52345929
DOI	https://doi.org/10.1186/ISRCTN52345929
Secondary identifying numbers	TreatWELL study protocol V2 13.12.13

Submission date: 03/04/2014
Registration date: 20/05/2014
Last edited: 29/03/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

http://www.cancerresearchuk.org/cancer-help/trials/a-study-looking-at-giving-lifestyle-advice-to-people-having-treatment-for-bowel-cancer-treatwell

Contact information

Prof Annie Anderson
Scientific

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

ORCID ID	0000-0002-0047-4500
Email	a.s.anderson@dundee.ac.uk

Study information

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
Study setting(s)	Other
Study type	Quality of life
Participant information sheet	ISRCTN52345929_PIS_V3_18Dec13.pdf
Scientific title	TreatWELL - A feasibility study to assess the delivery of a lifestyle intervention for colorectal cancer patients undergoing potentially curative treatment
Study acronym	TreatWELL
Study objectives	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(s)	East of Scotland Research Ethics Service,17/12/2013, ref.13/ES/0153
Health condition(s) or problem(s) studied	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
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 study start date	01/12/2013
Completion date	30/06/2015

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	35
Key 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)
Key exclusion criteria	1. Severe cognitive impairment 2. Not fit for major surgery
Date of first enrolment	01/04/2014
Date of final enrolment	31/10/2014

Locations

Countries of recruitment

Scotland
United Kingdom

Study participating centre

Centre for Research into Cancer Prevention and Screening

Dundee
DD1 9SY
United Kingdom

Sponsor information

Tayside Medical Science Centre (UK)
Research organisation

TASC R&D Office
Ninewells Hospital and Medical School
Residency block Level 3
George Pirie Way
Dundee
DD1 9SY
United Kingdom

Phone	+44 1382740125
Email	f.nuritova@dundee.ac.uk
"ROR"	https://ror.org/000ywep40

Funders

Funder type

Government

Chief Scientist Office (UK), Ref. CZH/4/939
Government organisation / Local government

Alternative name(s): CSO
Location: United Kingdom

Results and Publications

Intention to publish date	30/09/2017
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
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 plan	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.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Plain English results				No	Yes
Participant information sheet	version V3	18/12/2013	11/08/2017	No	Yes
Protocol file	version V1	14/11/2013	11/08/2017	No	No
Results article	results	06/06/2018		Yes	No
HRA research summary			28/06/2023	No	No

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

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.