Healthy Eating and Active Lifestyle After Bowel Cancer: HEAL ABC (HEALABC)
11 de octubre de 2022 actualizado por: 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:
- 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
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
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 de estudio
Intervencionista
Inscripción (Actual)
35
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Manchester, Reino Unido, M13 9WL
- Manchester University NHS Foundation Trust
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Manchester, Reino Unido, M139PL
- The University of Manchester
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Great Manchester
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Manchester, Great Manchester, Reino Unido, M6 8HD
- Salford Royal NHS Foundation Trust
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
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).
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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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.
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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.
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Sin intervención: 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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Adherence to intervention
Periodo de tiempo: 3 months
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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.
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3 months
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Adherence to intervention
Periodo de tiempo: 6 months
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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.
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6 months
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Recruitment rates
Periodo de tiempo: 3 months
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Cumulative recruitment against target rate each month.
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3 months
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Recruitment rates
Periodo de tiempo: 6 months
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Cumulative recruitment against target rate each month.
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6 months
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Retention rates
Periodo de tiempo: 3 months
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Calculated as the number of participants who completed the study divided by the number of participants randomised.
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3 months
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Retention rates
Periodo de tiempo: 6 months
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Calculated as the number of participants who completed the study divided by the number of participants randomised.
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6 months
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Acceptability of the intervention
Periodo de tiempo: 3 months
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This will be qualitatively assessed through in depth interviews with a subset of the trial participants.
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3 months
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Acceptability of the intervention
Periodo de tiempo: 6 months
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This will be qualitatively assessed through in depth interviews with a subset of the trial participants.
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6 months
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Data completion rates
Periodo de tiempo: 3 months
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Completeness of collected data will be assessed for all time points (% missing).
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3 months
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Data completion rates
Periodo de tiempo: 6 months
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Completeness of collected data will be assessed for all time points (% missing).
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6 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in participants' experience, motivation, barriers and facilitators to use HEAL ABC resources and follow the intervention
Periodo de tiempo: 3 months and 6 months
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Qualitatively assessed with in depth interviews.
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3 months and 6 months
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Change in behaviour
Periodo de tiempo: Baseline, 3 months and 6 months
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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.
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Baseline, 3 months and 6 months
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Change in dietary intake
Periodo de tiempo: Baseline, 3 months and 6 months
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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.
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Baseline, 3 months and 6 months
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Change in BMI
Periodo de tiempo: Baseline, 3 months and 6 months
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Body weight [kg] and height [m] to calculate body mass index
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Baseline, 3 months and 6 months
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Change in waist to hip ratio
Periodo de tiempo: Baseline, 3 months and 6 months
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waist circumference [cm] and hip circumference [cm] to calculate waist to hip ratio
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Baseline, 3 months and 6 months
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Change in body composition (BIA)
Periodo de tiempo: Baseline, 3 months and 6 months
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lean mass [%] and fat mass [%] using bio-impedance machine
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Baseline, 3 months and 6 months
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Change in body composition (CT scan)
Periodo de tiempo: Baseline, 3 months and 6 months
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muscle mass [cm2] and fat mass [cm2]using CT scans body composition analysis
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Baseline, 3 months and 6 months
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Change in physical activity
Periodo de tiempo: Baseline, 3 months and 6 months
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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
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Baseline, 3 months and 6 months
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Change in step count
Periodo de tiempo: Baseline, 3 months and 6 months
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pedometer
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Baseline, 3 months and 6 months
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Patients' socio-demographic characteristics
Periodo de tiempo: Baseline
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age, gender, marital status, occupation, education, income, ethnicity, smoking status and number of supplements used
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Baseline
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Contact with primary and secondary healthcare services
Periodo de tiempo: 6 months
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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.
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6 months
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Mortality
Periodo de tiempo: 6 months
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Patient's medical records
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6 months
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Morbidity
Periodo de tiempo: 6 months
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Patient's medical records
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6 months
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Change in Quality of life
Periodo de tiempo: Baseline, 3 months and 6 months
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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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Baseline, 3 months and 6 months
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Jana Sremanakova, University of Manchester
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- 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.
- Burden 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.
- Burden 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.
- Wright 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.
- Aubrey 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.
- Sremanakova 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.
Enlaces Útiles
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
30 de enero de 2021
Finalización primaria (Actual)
30 de septiembre de 2022
Finalización del estudio (Actual)
30 de septiembre de 2022
Fechas de registro del estudio
Enviado por primera vez
9 de diciembre de 2019
Primero enviado que cumplió con los criterios de control de calidad
10 de enero de 2020
Publicado por primera vez (Actual)
13 de enero de 2020
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
12 de octubre de 2022
Última actualización enviada que cumplió con los criterios de control de calidad
11 de octubre de 2022
Última verificación
1 de octubre de 2022
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- NHS001653
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
Investigators have published detailed study protocol and will share further details in main study publications
Marco de tiempo para compartir IPD
Study protocol has been published and is available online
Criterios de acceso compartido de IPD
free access
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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