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

Healthy Eating and Active Lifestyle After Bowel Cancer - HEAL ABC Workbook: Development and Feasibility Trial

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

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer; Survivorship; Behavior, Health
• Intervention / Treatment: Behavioral: HEAL ABC

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.

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Manchester, United Kingdom, M13 9WL
    • Manchester University NHS Foundation Trust
  • Manchester, United Kingdom, M139PL
    • The University of Manchester
  • Great Manchester
    • Manchester, Great Manchester, United Kingdom, M6 8HD
      • Salford Royal NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HEAL ABC; 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; 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.
No Intervention: HEALTH; Participants allocated to the control group will be referred to publicly available resources on healthy lifestyle recommendations but will not receive any additional support.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in participants' experience, motivation, barriers and facilitators to use HEAL ABC resources and follow the intervention	Qualitatively assessed with in depth interviews.	3 months and 6 months
Change in behaviour	The health action process approach (HAPA) questionnaires, previously used in publications investigating changes in HAPA constructs in lifestyle interventions. A 5 point Likert scale will be used for each question. Minimum score is 15 and maximum score is 75. Higher score is better score.	Baseline, 3 months and 6 months
Change in dietary intake	Three day dietary assessment. Participants will complete prospectively food diary during the day and enter all foods and drinks consumed into online system for dietary assessment - INTAKE24.	Baseline, 3 months and 6 months
Change in BMI	Body weight [kg] and height [m] to calculate body mass index	Baseline, 3 months and 6 months
Change in waist to hip ratio	waist circumference [cm] and hip circumference [cm] to calculate waist to hip ratio	Baseline, 3 months and 6 months
Change in body composition (BIA)	lean mass [%] and fat mass [%] using bio-impedance machine	Baseline, 3 months and 6 months
Change in body composition (CT scan)	muscle mass [cm2] and fat mass [cm2]using CT scans body composition analysis	Baseline, 3 months and 6 months
Change in physical activity	Global Physical Activity Questionnaire is used to assess the metabolic equivalent (MET) based on Global Physical Activity Questionnaire Analysis Guide: https://www.who.int/ncds/surveillance/steps/resources/GPAQ_Analysis_Guide.pdf	Baseline, 3 months and 6 months
Change in step count	pedometer	Baseline, 3 months and 6 months
Patients' socio-demographic characteristics	age, gender, marital status, occupation, education, income, ethnicity, smoking status and number of supplements used	Baseline
Contact with primary and secondary healthcare services	The Healthcare Resource Use Questionnaire - questionnaire was developed by a health economist for the EU funded project 'PreventIT' (2016-2018, grant number 689238) responding to the Horizon 2020, Personalised Health and Care call PHC-21: Advancing active and healthy aging with ICT: Early risk detection and intervention. There is no set score - questionnaire is used to estimate the costs associated with different healthcare services used.	6 months
Mortality	Patient's medical records	6 months
Morbidity	Patient's medical records	6 months
Change in Quality of life	SF-12 questionnaire - 12 questions, total score can range from 0 to 100 (sore zero indicates the lowest level of health and 100 indicates the highest level of health).	Baseline, 3 months and 6 months

Collaborators and Investigators

• Sponsor: University of Manchester
• Investigators: Principal Investigator: Jana Sremanakova, University of Manchester

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Helpful Links

• Research website

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2021
• Primary Completion (Actual): September 30, 2022
• Study Completion (Actual): September 30, 2022

Study Registration Dates

• First Submitted: December 9, 2019
• First Submitted That Met QC Criteria: January 10, 2020
• First Posted (Actual): January 13, 2020

Study Record Updates

• Last Update Posted (Actual): October 12, 2022
• Last Update Submitted That Met QC Criteria: October 11, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: physical activity; cancer; colorectal; survivorship; diet; behaviour
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: NHS001653

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Investigators have published detailed study protocol and will share further details in main study publications
• IPD Sharing Time Frame: Study protocol has been published and is available online
• IPD Sharing Access Criteria: free access
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No