Web-based Lifestyle Program, mHealth and EMA Intervention, to Improve Weight Loss in Rural Stage I-III Postmenopausal Breast and Endometrial Cancer Survivors, HERO-C Trial
Health Engagement for Rural Ohio Cancer Survivors (HERO-C)
Descripción general del estudio
Estado
Condiciones
- Cáncer de mama anatómico en estadio I AJCC v8
- Cáncer de mama anatómico en estadio II AJCC v8
- Cáncer de mama anatómico en estadio III AJCC v8
- Carcinoma endometrial
- Etapa III Carcinoma de cuerpo uterino u carcinosarcoma AJCC V8
- Etapa I Carcinoma de corpus uterino o carcinosarcoma AJCC V8
- Etapa II Carcinoma de corpus uterino o carcinosarcoma AJCC V8
Intervención / Tratamiento
- Otro: Administración del Cuestionario
- Procedimiento: Colección de muestras biológicas
- Otro: Aerobic Exercise
- Otro: Dietary Intervention
- Otro: Discussion
- Otro: Internet-Based Intervention
- Otro: Resistance Training
- Otro: Supportive Care
- Otro: Supportive Care
- Otro: Goal Setting
- Otro: Medical Device Usage and Evaluation
- Conductual: Smartphone Application-based Intervention
- Procedimiento: Tailored Intervention
Descripción detallada
PRIMARY OBJECTIVES:
I. To determine the feasibility of an mHealth + EMA intervention in addition to the web-based lifestyle program with remote outcome assessments among rural breast and endometrial cancer survivors. (Aim 1) Ia. To identify rural cancer survivors' perspectives and unique needs/challenges of participating in a web-based lifestyle program via focus groups pre- and post-intervention (n=20); (Aim 1a) Ib. To determine the feasibility of mHealth + EMA among early non-responders (week 5-26); (Aim 1b) Ic. To determine the feasibility of remote outcome assessments. (Aim 1c) II. To determine the preliminary efficacy of the additional mHealth + EMA intervention for early non-responders from the web-based lifestyle program (within-person change from week 5-26). (Aim 2)
EXPLORATORY OBJECTIVE:
I. To explore the differences in metabolomic, inflammatory, behavioral, and psychosocial factors between early responders and early non-responders at baseline, month 1 and month 6.
OUTLINE:
PHASE I (WEEKS 1-4): Patients complete self-paced web-based lifestyle program modules over 45-90 minutes weekly for 4 weeks. Patients adhere to a personalized diet meeting American Institute of Cancer Research (AICR) guidelines and receive access to online resources, including AICR resources, online cooking class videos, healthy eating recipes and tips. Patients participate in moderate-intensity aerobic physical activity over 10-30 minutes on 5 days weekly and resistance training over 30 minutes on 2-3 times weekly.
PHASE II (WEEKS 5-26): Patients are assigned to 1 of 2 groups based on Phase I progress.
GROUP I (EARLY RESPONDER): Patients continue web-based program modules, exercise program and diet recommendations as in Phase I. Patients also attend virtual group sessions over 45-50 minutes weekly for weeks 5-26.
GROUP II (EARLY NON-RESPONDER): Patients continue web-based program modules, exercise program and diet recommendations as in Phase I. Patients also set goals for behavioral changes weekly and receive just-in-time adaptive interventions (JITAI) tailored resource components via mHealth + EMA during weeks 5-26. Patients wear a physical activity tracker daily and receive access to the Fitbit application (App).
Patients may also participate in a focus group over 30-45 minutes on study. Additionally, patients undergo urine and blood sample collection throughout the study.
After completion of study intervention, patients may follow up in 6 months.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: The Ohio State University Comprehensive Cancer Center
- Número de teléfono: 800-293-5066
- Correo electrónico: OSUCCCClinicaltrials@osumc.edu
Ubicaciones de estudio
-
-
Ohio
-
Columbus, Ohio, Estados Unidos, 43210
- Ohio State University Comprehensive Cancer Center
-
Contacto:
- Xiaochen Zhang, PhD
- Número de teléfono: 614-685-0624
- Correo electrónico: Xiaochen.Zhang@osumc.edu
-
Investigador principal:
- Xiaochen Zhang, PhD
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Body mass index (BMI) ≥ 25kg/m^2
- Age: 40-69 years
- 1-5 years post-diagnosis of stage I-III postmenopausal breast cancer or stage I-III endometrial cancer
- No known evidence of recurrence (local or distant) or second, primary cancer
- No prior history of new other malignancy since their breast or endometrial cancer diagnosis (other than non-melanoma skin cancer)
- Not currently participating in any weight loss programs, no personal trainer, and not meeting the physical activity guidelines
- No use of any anti-obesity medications in the last 6 months and no plan to start anti-obesity medications during the study period
- The ability to walk two blocks without a walker or cane
- The ability to speak and read English
- Have access to internet with a computer, tablet, or smart phone
- Live in rural counties in Ohio and not planning to move away during the study
- Are not pregnant, breastfeeding or less than 12-month post-partum and do not plan to become pregnant during the study
Exclusion Criteria:
- Severe medical conditions, such as unstable cardiovascular disease or digestive disorders, that would preclude physical activity and dietary intervention
- Lack of physician clearance if determined necessary by the Physical Activity Readiness Questionnaire (PAR-Q+)
- Acute physical limitations for unsupervised exercises at home
- Unable to give informed consent
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación Secuencial
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Group I (web-based lifestyle program, virtual group)
PHASE I (WEEKS 1-4): Patients complete self-paced web-based lifestyle program modules over 45-90 minutes weekly for 4 weeks. Patients adhere to a personalized diet meeting AICR guidelines and receive access to online resources, including AICR resources, online cooking class videos, healthy eating recipes and tips. Patients participate in moderate-intensity aerobic physical activity over 10-30 minutes on 5 days weekly and resistance training over 30 minutes on 2-3 times weekly. PHASE II (WEEKS 5-26): Patients continue web-based program modules, exercise program and diet recommendations as in Phase I. Patients also attend virtual group sessions over 45-50 minutes weekly for weeks 5-26. Patients may also participate in a focus group over 30-45 minutes on study. Additionally, patients undergo urine and blood sample collection throughout the study. |
Estudios complementarios
Someterse a una recolección de muestras de orina y sangre.
Otros nombres:
Participate in moderate-intensity aerobic physical activity
Otros nombres:
Adhere to a personalized diet
Otros nombres:
Participate in a focus group
Otros nombres:
Complete self-paced web-based lifestyle program modules
Participate in resistance training
Otros nombres:
Receive access to online resources
Otros nombres:
Attend virtual group sessions
Otros nombres:
|
|
Experimental: Group II (web-based lifestyle, JITAI)
PHASE I (WEEKS 1-4): Patients complete self-paced web-based lifestyle program modules over 45-90 minutes weekly for 4 weeks. Patients adhere to a personalized diet meeting AICR guidelines and receive access to online resources, including AICR resources, online cooking class videos, healthy eating recipes and tips. Patients participate in moderate-intensity aerobic physical activity over 10-30 minutes on 5 days weekly and resistance training over 30 minutes on 2-3 times weekly. PHASE II (WEEKS 5-26): Patients continue web-based program modules, exercise program and diet recommendations as in Phase I. Patients also set goals for behavioral changes weekly and receive JITAI tailored resource components via mHealth + EMA during weeks 5-26. Patients wear a physical activity tracker daily and receive access to the Fitbit App. Patients may also participate in a focus group over 30-45 minutes on study. Patients undergo urine and blood sample collection throughout the study. |
Estudios complementarios
Someterse a una recolección de muestras de orina y sangre.
Otros nombres:
Participate in moderate-intensity aerobic physical activity
Otros nombres:
Adhere to a personalized diet
Otros nombres:
Participate in a focus group
Otros nombres:
Complete self-paced web-based lifestyle program modules
Participate in resistance training
Otros nombres:
Receive access to online resources
Otros nombres:
Attend virtual group sessions
Otros nombres:
Set goals for behavioral changes
Wear a physical activity tracker
Receive access to the Fitbit app
Otros nombres:
Receive JITAI tailored resource components
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Preferences, needs and satisfaction (Aim 1a)
Periodo de tiempo: At pre- and post-intervention, assessed up to week 26
|
Focus groups will be audio recorded through online videoconference (e.g.
Teams) and transcribed using NVivo.
Content analysis will be conducted to identify patterns, themes, and perspectives from participants using NVivo coding or similar software.
When possible, the frequency, intensity, and context of certain perspectives will be described.
Similarly, thematic analysis will be conducted using NVivo to identify themes (e.g., likes/dislikes, motivations, expectations) and mapped to potential intervention components.
|
At pre- and post-intervention, assessed up to week 26
|
|
Percentage of early non-responders who complete the mobile Health + ecological momentary assessment intervention (Aim 1b)
Periodo de tiempo: Up to week 26
|
Will report the frequency, proportion, and 95% confidence intervals (CIs) of early non-responders who completed the intervention.
|
Up to week 26
|
|
Percentage of all participants who complete all assessments (Aim 1c)
Periodo de tiempo: Up to week 26
|
Will report the frequency, proportion, and 95% CIs of all participants who completed outcome assessments.
|
Up to week 26
|
|
Changes in weight (Aim 2)
Periodo de tiempo: At baseline (T0), at week 4 (T1), and at week 26 (T2)
|
Linear mixed models will be used to account for repeated measures, with random effects for the individual.
The linear mixed models will use all available data under a missing-at-random assumption and will assess potential attrition bias by comparing baseline/week 4 characteristics of completers versus non-completers, with sensitivity analyses is missingness appears outcome-related.
Will report the preliminary effect size as within-person changes on weight (from week 4 to week 26).
|
At baseline (T0), at week 4 (T1), and at week 26 (T2)
|
|
Changes in muscle mass (Aim 2)
Periodo de tiempo: At baseline (T0), at week 4 (T1), and at week 26 (T2)
|
Will estimate the preliminary effect size using linear mixed models.
|
At baseline (T0), at week 4 (T1), and at week 26 (T2)
|
|
Changes in metabolic profiles (Aim 2)
Periodo de tiempo: At baseline (T0), at week 4 (T1), and at week 26 (T2)
|
Will estimate the preliminary effect size using linear mixed models.
|
At baseline (T0), at week 4 (T1), and at week 26 (T2)
|
|
Changes in inflammatory markers (Aim 2)
Periodo de tiempo: At baseline (T0), at week 4 (T1), and at week 26 (T2)
|
Will estimate the preliminary effect size using linear mixed models.
|
At baseline (T0), at week 4 (T1), and at week 26 (T2)
|
|
Changes in behaviors (Aim 2)
Periodo de tiempo: At baseline (T0), at week 4 (T1), and at week 26 (T2)
|
Will estimate the preliminary effect size using linear mixed models.
|
At baseline (T0), at week 4 (T1), and at week 26 (T2)
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Xiaochen Zhang, PhD, Ohio State University Comprehensive Cancer Center
Publicaciones y enlaces útiles
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Enfermedades urogenitales
- Enfermedades Genitales
- Neoplasias urogenitales
- Neoplasias por sitio
- Neoplasias
- Enfermedades urogenitales femeninas
- Enfermedades urogenitales femeninas y complicaciones del embarazo
- Neoplasias por tipo histológico
- Enfermedades uterinas
- Enfermedades Genitales Femeninas
- Neoplasias Genitales Femeninas
- Neoplasias Uterinas
- Sarcoma
- Neoplasias De Tejidos Conectivos Y Blandos
- Neoplasias Complejas y Mixtas
- Neoplasias Endometriales
- Carcinosarcoma
- Organización y administración
- Administración de Servicios de Salud
- Actividad motora
- Movimiento
- Fenómenos fisiológicos musculoesqueléticos
- Fenómenos fisiológicos musculoesqueléticos y neuronales
- Técnicas de investigación
- Terapéutica
- Técnicas de laboratorio clínico
- Técnicas y procedimientos de diagnóstico
- Diagnóstico
- Modalidades de fisioterapia
- Atención al paciente
- Servicios de salud
- Instalaciones de atención médica Fuerza laboral y servicios
- Terapia de ejercicio
- Rehabilitación
- Cuidado por los convalecientes
- Continuidad de la atención al paciente
- Terapia nutricional
- Acondicionamiento físico, humano
- Ejercicio
- Cuidados paliativos
- Manejo de muestras
- Entrenamiento de resistencia
- Terapia de dieta
- Objetivos de la organización
Otros números de identificación del estudio
- OSU-26016
- NCI-2026-05189 (Identificador de registro: CTRP (Clinical Trial Reporting Program))
- STUDY20252952
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .