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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN52345929

Enrollment

Registered

2014-05-20

Start date

2014-04-01

Completion date

Unknown

Last updated

2019-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bowel cancer / Diagnosis of Bowel Cancer / Lifestyle intervention Cancer

Interventions

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 cessat

Eligibility

Sex/Gender

All

Inclusion criteria

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)

Exclusion criteria

Exclusion criteria: 1. Severe cognitive impairment 2. Not fit for major surgery

Design outcomes

Primary

Measure	Time frame
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).	—

Measure

Time frame

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).

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Secondary

Measure	Time frame
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).	—

Measure

Time frame

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).

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Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 24, 2026