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)
Aperçu de l'étude
Statut
Les conditions
- Cancer du sein anatomique de stade I AJCC v8
- Cancer du sein anatomique de stade II AJCC v8
- Cancer du sein anatomique de stade III AJCC v8
- Carcinome de l'endomètre
- Stade III Carcinome ou carcinosarcome du corpus ou carcinosarcome AJCC V8
- Stage I Utérine Corpus Carcinome ou Carcinosarcome AJCC V8
- Carcinome ou carcinosarcome du corpus utérin ou carcinosarcome AJCC V8
Intervention / Traitement
- Autre: Gestion des questionnaires
- Procédure: Collecte d'échantillons biologiques
- Autre: Aerobic Exercise
- Autre: Dietary Intervention
- Autre: Discussion
- Autre: Internet-Based Intervention
- Autre: Resistance Training
- Autre: Supportive Care
- Autre: Supportive Care
- Autre: Goal Setting
- Autre: Medical Device Usage and Evaluation
- Comportemental: Smartphone Application-based Intervention
- Procédure: Tailored Intervention
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: The Ohio State University Comprehensive Cancer Center
- Numéro de téléphone: 800-293-5066
- E-mail: OSUCCCClinicaltrials@osumc.edu
Lieux d'étude
-
-
Ohio
-
Columbus, Ohio, États-Unis, 43210
- Ohio State University Comprehensive Cancer Center
-
Contact:
- Xiaochen Zhang, PhD
- Numéro de téléphone: 614-685-0624
- E-mail: Xiaochen.Zhang@osumc.edu
-
Chercheur principal:
- Xiaochen Zhang, PhD
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Non randomisé
- Modèle interventionnel: Affectation séquentielle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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. |
Etudes annexes
Effectuer un prélèvement d'échantillons d'urine et de sang
Autres noms:
Participate in moderate-intensity aerobic physical activity
Autres noms:
Adhere to a personalized diet
Autres noms:
Participate in a focus group
Autres noms:
Complete self-paced web-based lifestyle program modules
Participate in resistance training
Autres noms:
Receive access to online resources
Autres noms:
Attend virtual group sessions
Autres noms:
|
|
Expérimental: 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. |
Etudes annexes
Effectuer un prélèvement d'échantillons d'urine et de sang
Autres noms:
Participate in moderate-intensity aerobic physical activity
Autres noms:
Adhere to a personalized diet
Autres noms:
Participate in a focus group
Autres noms:
Complete self-paced web-based lifestyle program modules
Participate in resistance training
Autres noms:
Receive access to online resources
Autres noms:
Attend virtual group sessions
Autres noms:
Set goals for behavioral changes
Wear a physical activity tracker
Receive access to the Fitbit app
Autres noms:
Receive JITAI tailored resource components
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Preferences, needs and satisfaction (Aim 1a)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
|
Collaborateurs et enquêteurs
Collaborateurs
Les enquêteurs
- Chercheur principal: Xiaochen Zhang, PhD, Ohio State University Comprehensive Cancer Center
Publications et liens utiles
Liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Maladies urogénitales
- Maladies génitales
- Tumeurs urogénitales
- Tumeurs par site
- Tumeurs
- Maladies urogénitales féminines
- Maladies urogénitales féminines et complications de la grossesse
- Tumeurs par type histologique
- Maladies utérines
- Maladies génitales, femme
- Tumeurs génitales, femme
- Tumeurs utérines
- Sarcome
- Tumeurs, tissus conjonctifs et mous
- Tumeurs, complexes et mixtes
- Tumeurs de l'endomètre
- Carcinosarcome
- Organisation et administration
- Administration des services de santé
- Activité motrice
- Mouvement
- Phénomènes physiologiques musculo-squelettiques
- Phénomènes physiologiques musculo-squelettiques et neuronaux
- Techniques d'investigation
- Thérapeutique
- Techniques de laboratoire clinique
- Techniques et procédures de diagnostic
- Diagnostic
- Modalités de physiothérapie
- Soins aux patients
- Services de santé
- Conseils de soins de santé
- Thérapie d'exercice
- Réhabilitation
- Suivi
- Continuité des soins aux patients
- Thérapie nutritionnelle
- Conditionnement physique, humain
- Exercice
- Soins palliatifs
- Manipulation des échantillons
- Formation en résistance
- Thérapie de régime
- Objectifs organisationnels
Autres numéros d'identification d'étude
- OSU-26016
- NCI-2026-05189 (Identificateur de registre: CTRP (Clinical Trial Reporting Program))
- STUDY20252952
Informations sur les médicaments et les dispositifs, documents d'étude
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