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 |
| Protocol serial number | TreatWELL study protocol V2 13.12.13 |
| Sponsor | Tayside Medical Science Centre (UK) |
| Funder | Chief Scientist Office (UK), Ref. CZH/4/939 |
- 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
Plain English summary of protocol
Contact information
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
| 0000-0002-0047-4500 | |
| a.s.anderson@dundee.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Non-randomised feasibility trial to inform the feasibility of undertaking a future randomised controlled trial |
| Secondary study design | Non randomised controlled trial |
| 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(s) |
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. |
| Key secondary outcome measure(s) |
1. Self-reported smoking, self-reported alcohol intake, physical activity (Scottish physical activity questionnaire and 6 minute walk test) |
| Completion date | 30/06/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- Scotland
Study participating centre
DD1 9SY
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| 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? |
|---|---|---|---|---|---|
| Results article | results | 06/06/2018 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No | ||
| Participant information sheet | version V3 | 18/12/2013 | 11/08/2017 | No | Yes |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Plain English results | No | Yes | |||
| Protocol file | version V1 | 14/11/2013 | 11/08/2017 | 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.