Clinical trial NCT04227353: Healthy Eating and Active Lifestyle After Bowel Cancer: HEAL ABC
Official title: Healthy Eating and Active Lifestyle After Bowel Cancer - HEAL ABC Workbook: Development and Feasibility Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Survivorship
Behavior, Health
Keywords: colorectal
cancer
diet
physical activity
survivorship
behaviour
Lead sponsor: University of Manchester
Sponsor class: OTHER
First posted: 2020-01-13
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study is prospective randomised controlled trial, open label, exploratory/feasibility trial. 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.
Primary purpose: PREVENTION

Brief summary: 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

Detailed 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Adherence to intervention
timeFrame: 3 months
measure: Adherence to intervention
timeFrame: 6 months
measure: Recruitment rates
timeFrame: 3 months
measure: Recruitment rates
timeFrame: 6 months
measure: Retention rates
timeFrame: 3 months
measure: Retention rates
timeFrame: 6 months
measure: Acceptability of the intervention
timeFrame: 3 months
measure: Acceptability of the intervention
timeFrame: 6 months
measure: Data completion rates
timeFrame: 3 months
measure: Data completion rates
timeFrame: 6 months
Secondary outcomes:
measure: Change in participants' experience, motivation, barriers and facilitators to use HEAL ABC resources and follow the intervention
timeFrame: 3 months and 6 months
measure: Change in behaviour
timeFrame: Baseline, 3 months and 6 months
measure: Change in dietary intake
timeFrame: Baseline, 3 months and 6 months
measure: Change in BMI
timeFrame: Baseline, 3 months and 6 months
measure: Change in waist to hip ratio
timeFrame: Baseline, 3 months and 6 months
measure: Change in body composition (BIA)
timeFrame: Baseline, 3 months and 6 months
measure: Change in body composition (CT scan)
timeFrame: Baseline, 3 months and 6 months
measure: Change in physical activity
timeFrame: Baseline, 3 months and 6 months
measure: Change in step count
timeFrame: Baseline, 3 months and 6 months
measure: Patients' socio-demographic characteristics
timeFrame: Baseline
measure: Contact with primary and secondary healthcare services
timeFrame: 6 months
measure: Mortality
timeFrame: 6 months
measure: Morbidity
timeFrame: 6 months
measure: Change in Quality of life
timeFrame: Baseline, 3 months and 6 months
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Salford Royal NHS Foundation Trust
state: Great Manchester
city: Manchester
country: United Kingdom
facility: Manchester University NHS Foundation Trust
city: Manchester
country: United Kingdom
facility: The University of Manchester
Study officials:
affiliation: University of Manchester
name: Jana Sremanakova
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sremanakova J, Jones D, Cooke R, Burden S. Exploring Views of Healthcare Professionals, Researchers, and People Living with and beyond Colorectal Cancer on a Healthy-Eating and Active Lifestyle Resource. Nutrients. 2019 Oct 16;11(10):2482. doi: 10.3390/nu11102482.
citation: Burden S, Jones DJ, Sremanakova J, Sowerbutts AM, Lal S, Pilling M, Todd C. Dietary interventions for adult cancer survivors. Cochrane Database Syst Rev. 2019 Nov 22;2019(11):CD011287. doi: 10.1002/14651858.CD011287.pub2.
citation: Burden S, Sremanakova J, Jones D, Todd C. Dietary interventions for cancer survivors. Proc Nutr Soc. 2019 Feb;78(1):135-145. doi: 10.1017/S0029665118002690. Epub 2018 Dec 19.
citation: Wright SJ, Gibson D, Eden M, Lal S, Todd C, Ness A, Burden S. What are colorectal cancer survivors' preferences for dietary advice? A best-worst discrete choice experiment. J Cancer Surviv. 2017 Dec;11(6):782-790. doi: 10.1007/s11764-017-0615-2. Epub 2017 Apr 20.
citation: Aubrey V, Hon Y, Shaw C, Burden S. Healthy eating interventions in adults living with and beyond colorectal cancer: a systematic review. J Hum Nutr Diet. 2019 Aug;32(4):501-511. doi: 10.1111/jhn.12651. Epub 2019 Apr 3.
citation: Sremanakova J, Sowerbutts AM, Todd C, Cooke R, Burden S. Healthy Eating and Active Lifestyle After Bowel Cancer (HEAL ABC): feasibility randomised controlled trial protocol. Pilot Feasibility Stud. 2020 Nov 13;6(1):176. doi: 10.1186/s40814-020-00721-y.