Healthy Eating and Active Lifestyle After Bowel Cancer: HEAL ABC

NCT04227353 | Completed DMC

• 1 other identifier: NHS001653
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 3

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

Conditions

Colorectal Cancer; Survivorship; Behavior, Health

Keywords

colorectal; cancer; diet; physical activity; survivorship; behaviour

Outcome Measures

Primary Outcomes (10)

• Adherence to intervention

  Assessed as adherence to WCRF/AICR guidelines by using a scoring system for nutrition and physical activity guideline adherence developed by McCullough and colleagues. Number of goals set and number of changes implemented in everyday life during the 3 months intervention.

  3 months

• Adherence to intervention

  Assessed as adherence to WCRF/AICR guidelines by using a scoring system for nutrition and physical activity guideline adherence developed by McCullough and colleagues. Number of goals set and number of changes implemented in everyday life during the 6 months follow up.

  6 months

• Recruitment rates

  Cumulative recruitment against target rate each month.

  3 months

• Recruitment rates

  Cumulative recruitment against target rate each month.

  6 months

• Retention rates

  Calculated as the number of participants who completed the study divided by the number of participants randomised.

  3 months

• Retention rates

  Calculated as the number of participants who completed the study divided by the number of participants randomised.

  6 months

• Acceptability of the intervention

  This will be qualitatively assessed through in depth interviews with a subset of the trial participants.

  3 months

• Acceptability of the intervention

  This will be qualitatively assessed through in depth interviews with a subset of the trial participants.

  6 months

• Data completion rates

  Completeness of collected data will be assessed for all time points (% missing).

  3 months

• Data completion rates

  Completeness of collected data will be assessed for all time points (% missing).

  6 months

Secondary Outcomes (14)

• Change in participants' experience, motivation, barriers and facilitators to use HEAL ABC resources and follow the intervention

  3 months and 6 months

• Change in behaviour

  Baseline, 3 months and 6 months

• Change in dietary intake

  Baseline, 3 months and 6 months

• Change in BMI

  Baseline, 3 months and 6 months

• Change in waist to hip ratio

  Baseline, 3 months and 6 months

Study Arms (2)

HEAL ABC

EXPERIMENTAL

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.

Behavioral: HEAL ABC

HEALTH

NO INTERVENTION

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

Interventions

HEAL ABC BEHAVIORAL

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. After the participant achieves successful behaviour change, he or she can move more confidently to the next booklet. Support will be provided every two weeks over the phone for 12 weeks. 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 new goals.

HEAL ABC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Manchester: lead

Study Sites (3)

Salford Royal NHS Foundation Trust

Manchester, Great Manchester, M6 8HD, United Kingdom

Location

Manchester University NHS Foundation Trust

Manchester, M13 9WL, United Kingdom

Location

The University of Manchester

Manchester, M139PL, United Kingdom

Location

Related Publications (6)

• 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.

  PMID: 31623177 BACKGROUND

• 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.

  PMID: 31755089 BACKGROUND

• 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.

  PMID: 30563580 BACKGROUND

• 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.

  PMID: 28429186 BACKGROUND

• 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.

  PMID: 30941834 BACKGROUND

• 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.

  PMID: 33292854 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms; Health Behavior; Neoplasms; Motor Activity; Behavior

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Jana Sremanakova

  University of Manchester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD student, Nutrition Research Assistant

Model Details: 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.

Study Record Dates

• First Submitted: December 9, 2019
• First Posted: January 13, 2020
• Study Start: January 30, 2021
• Primary Completion: September 30, 2022
• Study Completion: September 30, 2022
• Last Updated: October 12, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Study protocol has been published and is available online
• Access Criteria: free access

Locations

GB (3)