An interventional study of HEAL ABC in Colorectal Cancer, Survivorship and Behavior, Health, sponsored by University of Manchester. Completed at 3 sites in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-10-12.
Sponsored by University of Manchester · Not applicable, Interventional, and Prevention
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:
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
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.
5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.
This study's enrollment of 35 is below the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →University of Manchester is the lead sponsor of 194 studies on the registry; 43 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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 allocated to the control group will be referred to publicly available resources on healthy lifestyle recommendations but will not receive any additional support.
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.
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.
Time frame: 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.
Time frame: 6 months
Recruitment rates
Cumulative recruitment against target rate each month.
Time frame: 3 months
Recruitment rates
Cumulative recruitment against target rate each month.
Time frame: 6 months
Retention rates
Calculated as the number of participants who completed the study divided by the number of participants randomised.
Time frame: 3 months
Retention rates
Calculated as the number of participants who completed the study divided by the number of participants randomised.
Time frame: 6 months
Acceptability of the intervention
This will be qualitatively assessed through in depth interviews with a subset of the trial participants.
Time frame: 3 months
Acceptability of the intervention
This will be qualitatively assessed through in depth interviews with a subset of the trial participants.
Time frame: 6 months
Data completion rates
Completeness of collected data will be assessed for all time points (% missing).
Time frame: 3 months
Data completion rates
Completeness of collected data will be assessed for all time points (% missing).
Time frame: 6 months
Change in participants' experience, motivation, barriers and facilitators to use HEAL ABC resources and follow the intervention
Qualitatively assessed with in depth interviews.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 3 months and 6 months
Change in BMI
Body weight \[kg\] and height \[m\] to calculate body mass index
Time frame: 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
Time frame: Baseline, 3 months and 6 months
Change in body composition (BIA)
lean mass \[%\] and fat mass \[%\] using bio-impedance machine
Time frame: 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
Time frame: 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
Time frame: Baseline, 3 months and 6 months
Change in step count
pedometer
Time frame: 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
Time frame: 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.
Time frame: 6 months
Mortality
Patient's medical records
Time frame: 6 months
Morbidity
Patient's medical records
Time frame: 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).
Time frame: Baseline, 3 months and 6 months
Plan to share: Yes — Investigators have published detailed study protocol and will share further details in main study publications
Supporting information: Study protocol
This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
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University of Manchester