Healthy Eating and Active Lifestyle After Bowel Cancer: HEAL ABC (HEALABC)

University of Manchester

Status: Completed

Conditions: Survivorship; Behavior, Health; Colorectal Cancer

Treatments: Behavioral: HEAL ABC

Study type: Interventional

Funder types: Other

Identifiers

NCT04227353

NHS001653

Details and patient eligibility

About

Trial Design:

This is a feasibility randomised controlled trial.

Aim:

The study aims to test the Healthy Eating and Active Lifestyle After Bowel Cancer - HEAL ABC intervention and HEAL ABC resources for feasibility and will inform a future definitive randomised controlled trial (RCT).

Objectives:

1. Is it practical to run HEAL ABC study as a definitive randomised controlled trial?
2. Adherence to intervention, motivations, barriers and facilitators of CRC survivors to follow HEAL ABC.

Study Population:

Colorectal cancer survivors who completed surgery and/or active treatment.

Intervention:

The intervention group will use HEAL ABC resource with supportive telephone calls every two weeks during the intervention period and once a month during the follow up period.

Control:

Participants follow standard care recommendations.

Timing and duration:

3 months intervention with 6 months follow up period

Full description

Background:

Investigators were awarded a grant to develop a lifestyle resource called HEAL ABC - the Healthy Eating and Active Lifestyle After Bowel Cancer. This resource is based on prevention guidelines of World Cancer Research Fund and American Institute of Cancer Research. The resource was developed in cooperation with a psychologist and so has incorporated behaviour change theory. Investigators organised focused groups with patients and healthcare professionals, and amended the resource based on their feedback.

In this study, investigators will test the HEAL ABC resource and the HEAL ABC intervention for its practicality before further studies will be conducted.

HEAL ABC consists of 10 booklets and supportive materials. The order for using the booklets is not specified. Participants will be assigned their first booklet based on the one they perceive to be the easiest for setting an incremental goal and achieving it. This means the participant starts with the booklet of the highest self-efficacy and after the participant achieves successful behaviour change, he or she can move more confidently to the next booklet. During the follow up period, participants will use the follow up booklet which helps them to continue with changes they have made and encourage them to set a new goals.

Participants in the intervention group will receive a supportive telephone call every two weeks during the intervention period (three months) and once a month during the six months follow up.

Participants allocated to the control group will given information about publicly available resources on healthy lifestyle recommendations. No additional support will be provided.

Primary Question/Objective:

Is it feasible to run a definitive RCT to determine the effectiveness of HEAL ABC? This study will address questions around suitability and practicality of using the HEAL ABC resource and the ability to run an intervention in relation to adherence, recruitment, retention rates and the ability to collect relevant data.

Secondary Question/Objective:

Adherence to intervention and the motivations, barriers and facilitators of CRC survivors to follow HEAL ABC.

Enrollment: 35 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults, age ≥18
• Minimum 12 weeks post-surgery and/or active treatment
• Completed all active anti-cancer treatments, including surgery, radiotherapy or chemotherapy
• Body mass index ≥20 kg/m2 and no previous unintentional weight loss ≥5% of body weight in the previous six months.
• Identified as living an unhealthy lifestyle based on current recommendations - follow less than four of the WCRF/AICR recommendations on eligibility questionnaire
• Ability to work with computer, smart phone or tablet.
• Able to give informed consent.

Exclusion criteria

• Receiving treatment for malignancy.
• Secondary malignancy.
• Having short bowel syndrome, Crohn's disease, ulcerative colitis, diverticulitis or jejunostomy (due to requirement for a very specific diet).
• Previous stroke, congested cardiac failure or oedema.
• Hepatic or renal failure
• Less than 12 weeks post-surgery or active treatment.
• Meeting the requirements of a healthy lifestyle (follow four or more of the WCRF/AICR recommendations).
• Being on any therapeutic diets, multiple food intolerances or allergies.
• Unplanned weight loss of ≥10% in the previous 3-6 months.
• Cannot read or communicate in English (due to resource constraints of this PhD study).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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35 participants in 2 patient groups

HEAL ABC

Experimental group

Description:

Participants allocated to the intervention will be encouraged to follow the HEAL ABC resources in order to make a healthy eating and active lifestyle change. This will be achieved by setting specific goal(s) and by making concrete plan(s) to implement changes in their everyday life. Interventions will be delivered in the form of written resources that will guide participants. Supportive phone calls using motivational interviewing techniques will be provided to participants every two weeks to encourage lifestyle changes.

Treatment:

Behavioral: HEAL ABC

HEALTH

No Intervention group

Description:

Participants allocated to the control group will be referred to publicly available resources on healthy lifestyle recommendations but will not receive any additional support.