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

11 oktober 2022 uppdaterad av: 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

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

35

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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).

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Förebyggande
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Beteende: 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.
Inget ingripande: 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.

Vad mäter studien?

Primära resultatmått

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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in participants' experience, motivation, barriers and facilitators to use HEAL ABC resources and follow the intervention
Tidsram: 3 months and 6 months
Qualitatively assessed with in depth interviews.
3 months and 6 months
Change in behaviour
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: Baseline, 3 months and 6 months
pedometer
Baseline, 3 months and 6 months
Patients' socio-demographic characteristics
Tidsram: Baseline
age, gender, marital status, occupation, education, income, ethnicity, smoking status and number of supplements used
Baseline
Contact with primary and secondary healthcare services
Tidsram: 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
Tidsram: 6 months
Patient's medical records
6 months
Morbidity
Tidsram: 6 months
Patient's medical records
6 months
Change in Quality of life
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

University of Manchester

Utredare

  • Huvudutredare: Jana Sremanakova, University of Manchester

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Användbara länkar

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

30 januari 2021

Primärt slutförande (Faktisk)

30 september 2022

Avslutad studie (Faktisk)

30 september 2022

Studieregistreringsdatum

Först inskickad

9 december 2019

Först inskickad som uppfyllde QC-kriterierna

10 januari 2020

Första postat (Faktisk)

13 januari 2020

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

12 oktober 2022

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

11 oktober 2022

Senast verifierad

1 oktober 2022

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • NHS001653

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

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

Tidsram för IPD-delning

Study protocol has been published and is available online

Kriterier för IPD Sharing Access

free access

IPD-delning som stöder informationstyp

  • STUDY_PROTOCOL

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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