Colorectal CancerHEALABCNCT04227353
Healthy Eating and Active Lifestyle After Bowel Cancer: HEAL ABC
A study testing HEAL ABC in people with Colorectal Cancer and Survivorship, run by University of Manchester at 3 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Survivorship, Behavior, Health
- What is being tested?
- HEAL ABC
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- 30 Jan 2021to 30 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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).
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
Salford Royal NHS Foundation Trust
Manchester, Great Manchester, M6 8HD
Manchester University NHS Foundation Trust
Manchester, M13 9WL
The University of Manchester
Manchester, M139PL
About this study
Official title: Healthy Eating and Active Lifestyle After Bowel Cancer - HEAL ABC Workbook: Development and Feasibility Trial
Trial Design:
This is a feasibility randomised controlled trial.
Read more
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:
- Is it practical to run HEAL ABC study as a definitive randomised controlled trial?
- 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
Read the 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.
- Conditions
- Colorectal Cancer, Survivorship, Behavior, Health
- Being tested
- HEAL ABC
- Keywords
- colorectal, cancer, diet, physical activity, survivorship, behaviour
- Medical subject headings
- Colorectal Neoplasms, Health Behavior, Neoplasms, Motor Activity, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HEAL ABCBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6 months
Recruitment rates
Cumulative recruitment against target rate each month.
Measured: 3 months
Recruitment rates
Cumulative recruitment against target rate each month.
Measured: 6 months
Retention rates
Calculated as the number of participants who completed the study divided by the number of participants randomised.
Measured: 3 months
Retention rates
Calculated as the number of participants who completed the study divided by the number of participants randomised.
Measured: 6 months
Acceptability of the intervention
This will be qualitatively assessed through in depth interviews with a subset of the trial participants.
Measured: 3 months
Acceptability of the intervention
This will be qualitatively assessed through in depth interviews with a subset of the trial participants.
Measured: 6 months
Data completion rates
Completeness of collected data will be assessed for all time points (% missing).
Measured: 3 months
Data completion rates
Completeness of collected data will be assessed for all time points (% missing).
Measured: 6 months
Secondary outcomes (14)
Change in participants' experience, motivation, barriers and facilitators to use HEAL ABC resources and follow the intervention
Qualitatively assessed with in depth interviews.
Measured: 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.
Measured: 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.
Measured: Baseline, 3 months and 6 months
Change in BMI
Body weight [kg] and height [m] to calculate body mass index
Measured: 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
Measured: Baseline, 3 months and 6 months
Change in body composition (BIA)
lean mass [%] and fat mass [%] using bio-impedance machine
Measured: 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
Measured: 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
Measured: Baseline, 3 months and 6 months
Change in step count
pedometer
Measured: 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
Measured: 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.
Measured: 6 months
Mortality
Patient's medical records
Measured: 6 months
Morbidity
Patient's medical records
Measured: 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).
Measured: Baseline, 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2020
- Study start30 Jan 2021
- Primary completion30 Sep 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by University of ManchesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manchester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jana Sremanakova, University of Manchester
- Investigators
- Jana Sremanakova, Principal investigator, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04227353
- Sponsor's protocol ID
- NHS001653
- Acronym
- HEALABC
- Status last verified
- Oct 2022
- First submitted
- 9 Dec 2019
- Last updated
- 12 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Investigators have published detailed study protocol and will share further details in main study publications
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.
PubMed 31623177Burden 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.
PubMed 31755089Burden 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.
PubMed 30563580Wright 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.
PubMed 28429186Aubrey 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.
PubMed 30941834Sremanakova 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.
PubMed 33292854
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthy Eating and Active Lifestyle After Bowel Cancer - HEAL ABC Workbook: Development and Feasibility Trial
- ClinicalTrials.gov ID
- NCT04227353
- Acronym / sponsor ID
- HEALABC / NHS001653
- Conditions
- Colorectal Cancer, Survivorship, Behavior, Health
- Keywords
- colorectal, cancer, diet, physical activity, survivorship, behaviour
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of ManchesterUniversity, hospital or other
- Study start
- 30 Jan 2021 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 13 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Is it practical to run HEAL ABC study as a definitive randomised controlled trial?
- 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
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| HEAL ABC | Experimental | Behavioral: HEAL ABCParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HEAL ABCParticipants 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. | Behavioural | HEAL ABC |
Primary outcome
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.
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.
Recruitment rates
Time frame: 3 months
Cumulative recruitment against target rate each month.
Recruitment rates
Time frame: 6 months
Cumulative recruitment against target rate each month.
Retention rates
Time frame: 3 months
Calculated as the number of participants who completed the study divided by the number of participants randomised.
Retention rates
Time frame: 6 months
Calculated as the number of participants who completed the study divided by the number of participants randomised.
Acceptability of the intervention
Time frame: 3 months
This will be qualitatively assessed through in depth interviews with a subset of the trial participants.
Acceptability of the intervention
Time frame: 6 months
This will be qualitatively assessed through in depth interviews with a subset of the trial participants.
Data completion rates
Time frame: 3 months
Completeness of collected data will be assessed for all time points (% missing).
Data completion rates
Time frame: 6 months
Completeness of collected data will be assessed for all time points (% missing).
14 secondary outcomes
Change in participants' experience, motivation, barriers and facilitators to use HEAL ABC resources and follow the intervention
Time frame: 3 months and 6 months
Change in behaviour
Time frame: Baseline, 3 months and 6 months
Change in dietary intake
Time frame: Baseline, 3 months and 6 months
Change in BMI
Time frame: Baseline, 3 months and 6 months
Change in waist to hip ratio
Time frame: Baseline, 3 months and 6 months
Change in body composition (BIA)
Time frame: Baseline, 3 months and 6 months
Change in body composition (CT scan)
Time frame: Baseline, 3 months and 6 months
Change in physical activity
Time frame: Baseline, 3 months and 6 months
Change in step count
Time frame: Baseline, 3 months and 6 months
Patients' socio-demographic characteristics
Time frame: Baseline
Contact with primary and secondary healthcare services
Time frame: 6 months
Mortality
Time frame: 6 months
Morbidity
Time frame: 6 months
Change in Quality of life
Time frame: Baseline, 3 months and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2022.
- Background: PubMed 31623177Sremanakova 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.
- Background: PubMed 31755089Burden 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.
- Background: PubMed 30563580Burden 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.
- Background: PubMed 28429186Wright 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.
- Background: PubMed 30941834Aubrey 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.
- Derived from this study: PubMed 33292854Sremanakova 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.
- Individual participant dataSharing planned: Yes. Investigators have published detailed study protocol and will share further details in main study publications
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jana Sremanakova principal investigator
University of Manchester
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HEAL ABC in people with Colorectal Cancer and Survivorship, run by University of Manchester at 3 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to intervention (time frame: 3 months). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04227353, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2022; AzTrials last refreshed its copy on 8 Nov 2026.