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

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ClinicalTrials.gov Identifier: NCT04227353
Recruitment Status : Not yet recruiting
First Posted : January 13, 2020
Last Update Posted : January 13, 2020
Sponsor:
Information provided by (Responsible Party):
Jana Sremanakova, University of Manchester

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


Condition or disease Intervention/treatment Phase
Colorectal Cancer Survivorship Behavior, Health Behavioral: HEAL ABC Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Healthy Eating and Active Lifestyle After Bowel Cancer - HEAL ABC Workbook: Development and Feasibility Trial
Estimated Study Start Date : March 2, 2020
Estimated Primary Completion Date : December 30, 2021
Estimated Study Completion Date : September 30, 2022

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.



Primary Outcome Measures :
  1. Adherence to intervention [ Time Frame: 3 months ]
    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.

  2. Adherence to intervention [ Time Frame: 6 months ]
    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.

  3. Recruitment rates [ Time Frame: 3 months ]
    Cumulative recruitment against target rate each month.

  4. Recruitment rates [ Time Frame: 6 months ]
    Cumulative recruitment against target rate each month.

  5. Retention rates [ Time Frame: 3 months ]
    Calculated as the number of participants who completed the study divided by the number of participants randomised.

  6. Retention rates [ Time Frame: 6 months ]
    Calculated as the number of participants who completed the study divided by the number of participants randomised.

  7. Acceptability of the intervention [ Time Frame: 3 months ]
    This will be qualitatively assessed through in depth interviews with a subset of the trial participants.

  8. Acceptability of the intervention [ Time Frame: 6 months ]
    This will be qualitatively assessed through in depth interviews with a subset of the trial participants.

  9. Data completion rates [ Time Frame: 3 months ]
    Completeness of collected data will be assessed for all time points (% missing).

  10. Data completion rates [ Time Frame: 6 months ]
    Completeness of collected data will be assessed for all time points (% missing).


Secondary Outcome Measures :
  1. Change in participants' experience, motivation, barriers and facilitators to use HEAL ABC resources and follow the intervention [ Time Frame: 3 months and 6 months ]
    Qualitatively assessed with in depth interviews.

  2. Change in behaviour [ Time Frame: Baseline, 3 months and 6 months ]
    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.

  3. Change in dietary intake [ Time Frame: Baseline, 3 months and 6 months ]
    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.

  4. Change in BMI [ Time Frame: Baseline, 3 months and 6 months ]
    Body weight [kg] and height [m] to calculate body mass index

  5. Change in waist to hip ratio [ Time Frame: Baseline, 3 months and 6 months ]
    waist circumference [cm] and hip circumference [cm] to calculate waist to hip ratio

  6. Change in body composition (BIA) [ Time Frame: Baseline, 3 months and 6 months ]
    lean mass [%] and fat mass [%] using bio-impedance machine

  7. Change in body composition (CT scan) [ Time Frame: Baseline, 3 months and 6 months ]
    muscle mass [cm2] and fat mass [cm2]using CT scans body composition analysis

  8. Change in physical activity [ Time Frame: Baseline, 3 months and 6 months ]
    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

  9. Change in step count [ Time Frame: Baseline, 3 months and 6 months ]
    pedometer

  10. Patients' socio-demographic characteristics [ Time Frame: Baseline ]
    age, gender, marital status, occupation, education, income, ethnicity, smoking status and number of supplements used

  11. Contact with primary and secondary healthcare services [ Time Frame: 6 months ]
    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.

  12. Mortality [ Time Frame: 6 months ]
    Patient's medical records

  13. Morbidity [ Time Frame: 6 months ]
    Patient's medical records

  14. Change in Quality of life [ Time Frame: Baseline, 3 months and 6 months ]
    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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04227353


Locations
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United Kingdom
The University of Manchester
Manchester, United Kingdom, M139PL
Contact: Jana Sremanakova, MSc    +44(0)1613067673    jana.sremanakova@manchester.ac.uk   
Sponsors and Collaborators
University of Manchester
Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jana Sremanakova, PhD student, Nutrition Research Assistant, University of Manchester
ClinicalTrials.gov Identifier: NCT04227353    
Other Study ID Numbers: NHS001653
First Posted: January 13, 2020    Key Record Dates
Last Update Posted: January 13, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jana Sremanakova, University of Manchester:
colorectal
cancer
diet
physical activity
survivorship
behaviour
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases