Healthy Eating and Active Lifestyle After Bowel Cancer
Research type
Research Study
Full title
Healthy Eating and Active Lifestyle After Bowel Cancer - HEAL ABC Workbook: Development and feasibility trial.
IRAS ID
273818
Contact name
Jana Sremanakova
Contact email
Sponsor organisation
University of Manchester
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 6 months, 29 days
Research summary
Summary of Research
People after bowel cancer are at high risk of cancer returning and other health problems, and therefore strategies are needed to reduce these risks. One promising strategy targets modifiable lifestyle factors including diet and physical activity. However, effective, evidence-based resources helping people after bowel cancer to adopt new lifestyle habits are currently lacking.
The proposed study addresses the gap identified during our extensive work with colorectal cancer survivors and related healthcare professionals (Burden et al., 2014, Burden et al., 2016, Wright et al., 2017, Sremanakova et al., 2019). We also directly respond to one of the top 10-research priorities of cancer survivors reported by the National Cancer Institute and James Lind Alliance UK (National Cancer Research Institute, 2018).
Trial Design:
Feasibility randomised controlled trial.
Objectives:
1. Is it practical to run the Healthy Eating and Active Lifestyle (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.HEALTH group:
Participants follow standard care recommendations.Timing and duration:
3 months intervention with 6 months follow upResearch location:
Study will take place in Great Manchester and will involve the Salford Royal Foundation Trust and the Manchester University NHS Foundation Trust.Research funding:
Study is part of the doctoral degree and funded by the University of Manchester Division of Development and Alumni Relations (DDAR) - Research Impact Scholarship Award.Summary of Results
The Healthy Eating and Active Lifestyle After Bowel Cancer (HEAL ABC) study tested the HEAL ABC study design, resources, and their acceptability by people after colorectal cancer (CRC). It was a feasibility randomised controlled trial (RCT) based on World Cancer Research Fund Prevention Guidelines (WCRF/AICR), the Health Action Process Approach theory and the Motivational Interviewing technique.
Thirty-five participants were recruited and allocated to the usual care control group or a telephone-based intervention with printed resources and a website. The researcher collected data on anthropometry, diet, physical activity, quality of life, and behaviour change in both groups at baseline, three months post-intervention, and six-month follow-ups. A subgroup of participants took part in qualitative interviews.
Results:
Recruitment was challenging (35 recruited, 31 ineligible, and 37 eligible but declined). Of the 37 eligible, eleven were not interested, ten decided it was not the right time for them to take part, seven thought it was too much work, five thought they did not need support, and four did not want to state the reason. In total, 34 participants completed the three months intervention (97%), and 31 (89%) completed six months follow-up. The intervention was acceptable to participants. However, participants suggested changes such as reducing the paperwork at the start of the intervention, careful presentation of the study time frame and changes in phrasing and answer options in questionnaires.
The intervention was received well by the participants in both study groups. The study was seen as beneficial. All intervention participants completed all telephone calls. Participants suggested that three to six months after surgery or treatment is needed before they are ready to make lifestyle changes. Participants reported feeling left alone post-treatment and asked for further support with diet and exercise to gain clarity and reassurance. Intervention met their needs with the content and guidance and kept them accountable towards their lifestyle goals.
The intervention led to a slight weight and waist circumference reduction at six months post-intervention. The intervention group improved WCRF/AICR adherence scores, Diet Quality Index -International score (DQI-I) and overall physical activity. The control group improved vigorous physical exercise at six months post-intervention. However, the control group only marginally improved WCRF/AICR adherence and DQI-I scores.
Conclusion:
New strategies are needed to recruit people after CRC to trials. The HEAL ABC intervention was feasible to deliver, positively rated and reported as beneficial by participants, supporting them in healthy lifestyle changes. A fully powered trial is needed to report on the effect of the intervention.REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
20/NW/0083
Date of REC Opinion
21 Feb 2020
REC opinion
Favourable Opinion