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

11 oktober 2022 bijgewerkt door: Jana Sremanakova, University of Manchester

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

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

35

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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).

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Gedragsmatig: 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.
Geen tussenkomst: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Adherence to intervention
Tijdsspanne: 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.
3 months
Adherence to intervention
Tijdsspanne: 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.
6 months
Recruitment rates
Tijdsspanne: 3 months
Cumulative recruitment against target rate each month.
3 months
Recruitment rates
Tijdsspanne: 6 months
Cumulative recruitment against target rate each month.
6 months
Retention rates
Tijdsspanne: 3 months
Calculated as the number of participants who completed the study divided by the number of participants randomised.
3 months
Retention rates
Tijdsspanne: 6 months
Calculated as the number of participants who completed the study divided by the number of participants randomised.
6 months
Acceptability of the intervention
Tijdsspanne: 3 months
This will be qualitatively assessed through in depth interviews with a subset of the trial participants.
3 months
Acceptability of the intervention
Tijdsspanne: 6 months
This will be qualitatively assessed through in depth interviews with a subset of the trial participants.
6 months
Data completion rates
Tijdsspanne: 3 months
Completeness of collected data will be assessed for all time points (% missing).
3 months
Data completion rates
Tijdsspanne: 6 months
Completeness of collected data will be assessed for all time points (% missing).
6 months

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in participants' experience, motivation, barriers and facilitators to use HEAL ABC resources and follow the intervention
Tijdsspanne: 3 months and 6 months
Qualitatively assessed with in depth interviews.
3 months and 6 months
Change in behaviour
Tijdsspanne: 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.
Baseline, 3 months and 6 months
Change in dietary intake
Tijdsspanne: 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.
Baseline, 3 months and 6 months
Change in BMI
Tijdsspanne: Baseline, 3 months and 6 months
Body weight [kg] and height [m] to calculate body mass index
Baseline, 3 months and 6 months
Change in waist to hip ratio
Tijdsspanne: Baseline, 3 months and 6 months
waist circumference [cm] and hip circumference [cm] to calculate waist to hip ratio
Baseline, 3 months and 6 months
Change in body composition (BIA)
Tijdsspanne: Baseline, 3 months and 6 months
lean mass [%] and fat mass [%] using bio-impedance machine
Baseline, 3 months and 6 months
Change in body composition (CT scan)
Tijdsspanne: Baseline, 3 months and 6 months
muscle mass [cm2] and fat mass [cm2]using CT scans body composition analysis
Baseline, 3 months and 6 months
Change in physical activity
Tijdsspanne: 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
Baseline, 3 months and 6 months
Change in step count
Tijdsspanne: Baseline, 3 months and 6 months
pedometer
Baseline, 3 months and 6 months
Patients' socio-demographic characteristics
Tijdsspanne: Baseline
age, gender, marital status, occupation, education, income, ethnicity, smoking status and number of supplements used
Baseline
Contact with primary and secondary healthcare services
Tijdsspanne: 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.
6 months
Mortality
Tijdsspanne: 6 months
Patient's medical records
6 months
Morbidity
Tijdsspanne: 6 months
Patient's medical records
6 months
Change in Quality of life
Tijdsspanne: 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).
Baseline, 3 months and 6 months

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of Manchester

Onderzoekers

  • Hoofdonderzoeker: Jana Sremanakova, University of Manchester

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

30 januari 2021

Primaire voltooiing (Werkelijk)

30 september 2022

Studie voltooiing (Werkelijk)

30 september 2022

Studieregistratiedata

Eerst ingediend

9 december 2019

Eerst ingediend dat voldeed aan de QC-criteria

10 januari 2020

Eerst geplaatst (Werkelijk)

13 januari 2020

Updates van studierecords

Laatste update geplaatst (Werkelijk)

12 oktober 2022

Laatste update ingediend die voldeed aan QC-criteria

11 oktober 2022

Laatst geverifieerd

1 oktober 2022

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • NHS001653

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

Investigators have published detailed study protocol and will share further details in main study publications

IPD-tijdsbestek voor delen

Study protocol has been published and is available online

IPD-toegangscriteria voor delen

free access

IPD delen Ondersteunend informatietype

  • LEERPROTOCOOL

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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