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)
Panoramica dello studio
Stato
Condizioni
- Cancro al seno in stadio anatomico I AJCC v8
- Cancro al seno in stadio anatomico II AJCC v8
- Cancro al seno in stadio anatomico III AJCC v8
- Carcinoma endometriale
- Stage III CARCINOMA CORPUS UTERINO O CARCINOSARCOMA AJCC V8
- Stage I Uterino Corpus Carcinoma o Carcinosarcoma AJCC V8
- Fase II Carcinoma uterino corpus o carcinosarcoma AJCC V8
Intervento / Trattamento
- Altro: Amministrazione del questionario
- Procedura: Raccolta di campioni biologici
- Altro: Aerobic Exercise
- Altro: Dietary Intervention
- Altro: Discussion
- Altro: Internet-Based Intervention
- Altro: Resistance Training
- Altro: Supportive Care
- Altro: Supportive Care
- Altro: Goal Setting
- Altro: Medical Device Usage and Evaluation
- Comportamentale: Smartphone Application-based Intervention
- Procedura: Tailored Intervention
Descrizione dettagliata
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 di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: The Ohio State University Comprehensive Cancer Center
- Numero di telefono: 800-293-5066
- Email: OSUCCCClinicaltrials@osumc.edu
Luoghi di studio
-
-
Ohio
-
Columbus, Ohio, Stati Uniti, 43210
- Ohio State University Comprehensive Cancer Center
-
Contatto:
- Xiaochen Zhang, PhD
- Numero di telefono: 614-685-0624
- Email: Xiaochen.Zhang@osumc.edu
-
Investigatore principale:
- Xiaochen Zhang, PhD
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione sequenziale
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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. |
Studi accessori
Sottoponiti al prelievo di campioni di urina e di sangue
Altri nomi:
Participate in moderate-intensity aerobic physical activity
Altri nomi:
Adhere to a personalized diet
Altri nomi:
Participate in a focus group
Altri nomi:
Complete self-paced web-based lifestyle program modules
Participate in resistance training
Altri nomi:
Receive access to online resources
Altri nomi:
Attend virtual group sessions
Altri nomi:
|
|
Sperimentale: 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. |
Studi accessori
Sottoponiti al prelievo di campioni di urina e di sangue
Altri nomi:
Participate in moderate-intensity aerobic physical activity
Altri nomi:
Adhere to a personalized diet
Altri nomi:
Participate in a focus group
Altri nomi:
Complete self-paced web-based lifestyle program modules
Participate in resistance training
Altri nomi:
Receive access to online resources
Altri nomi:
Attend virtual group sessions
Altri nomi:
Set goals for behavioral changes
Wear a physical activity tracker
Receive access to the Fitbit app
Altri nomi:
Receive JITAI tailored resource components
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Preferences, needs and satisfaction (Aim 1a)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
|
Collaboratori e investigatori
Collaboratori
Investigatori
- Investigatore principale: Xiaochen Zhang, PhD, Ohio State University Comprehensive Cancer Center
Pubblicazioni e link utili
Collegamenti utili
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Malattie urogenitali
- Malattie genitali
- Neoplasie urogenitali
- Neoplasie per sede
- Neoplasie
- Malattie urogenitali femminili
- Malattie urogenitali femminili e complicanze della gravidanza
- Neoplasie per tipo istologico
- Malattie uterine
- Malattie genitali, femmina
- Neoplasie genitali, femmina
- Neoplasie uterine
- Sarcoma
- Neoplasie, Connettivo e Tessuto Molle
- Neoplasie Complesse e Miste
- Neoplasie endometriali
- Carcinosarcoma
- Organizzazione e amministrazione
- Amministrazione dei servizi sanitari
- Attività motoria
- Movimento
- Fenomeni fisiologici muscoloscheletrici
- Fenomeni fisiologici muscoloscheletrici e neurali
- Tecniche investigative
- Terapie
- Tecniche di laboratorio clinico
- Tecniche e procedure diagnostiche
- Diagnosi
- Modalità di terapia fisica
- Cura del paziente
- Servizi sanitari
- Force di lavoro e servizi per le strutture sanitarie
- Terapia di esercizio
- Riabilitazione
- Assistenza post -terapia
- Continuità della cura del paziente
- Terapia nutrizionale
- Condizionamento fisico, umano
- Esercizio
- Cure palliative
- Gestione dei campioni
- Allenamento di resistenza
- Terapia dietetica
- Obiettivi organizzativi
Altri numeri di identificazione dello studio
- OSU-26016
- NCI-2026-05189 (Identificatore di registro: CTRP (Clinical Trial Reporting Program))
- STUDY20252952
Informazioni su farmaci e dispositivi, documenti di studio
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