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

11 ottobre 2022 aggiornato da: 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

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

35

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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).

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Comportamentale: 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.
Nessun intervento: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

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

Misure di risultato secondarie

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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of Manchester

Investigatori

  • Investigatore principale: Jana Sremanakova, University of Manchester

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

30 gennaio 2021

Completamento primario (Effettivo)

30 settembre 2022

Completamento dello studio (Effettivo)

30 settembre 2022

Date di iscrizione allo studio

Primo inviato

9 dicembre 2019

Primo inviato che soddisfa i criteri di controllo qualità

10 gennaio 2020

Primo Inserito (Effettivo)

13 gennaio 2020

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

12 ottobre 2022

Ultimo aggiornamento inviato che soddisfa i criteri QC

11 ottobre 2022

Ultimo verificato

1 ottobre 2022

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • NHS001653

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

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

Periodo di condivisione IPD

Study protocol has been published and is available online

Criteri di accesso alla condivisione IPD

free access

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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