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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

2026년 7월 20일 업데이트: Xiaochen Zhang, Ohio State University Comprehensive Cancer Center

Health Engagement for Rural Ohio Cancer Survivors (HERO-C)

This clinical trial identifies the needs and preferences of rural stage I-III postmenopausal breast and endometrial cancer survivors and evaluates the impact of an adaptive, online program, mobile (m)Health + ecological momentary assessment (EMA) intervention, on lifestyle modification and their weight loss efforts. Obesity, a condition marked by an abnormally high, unhealthy amount of body fat, is associated with lower physical and psychological well-being, higher risk of recurrence, and higher cancer-specific and all-cause mortality (number of deaths). Lifestyle factors, such as low physical activity and unhealthy diet, are the main contributors to obesity that are modifiable. Lifestyle weight loss programs focusing on modifiable factors can improve cancer-specific survival and many aspects of health, but access to these programs can be challenging in rural settings. A remote lifestyle program, adapted to individual goals and needs, may help promote healthy behaviors, improve cancer outcomes, and reduce disease burden in stage I-III postmenopausal breast and endometrial cancer survivors.

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (추정된)

90

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

  • 미국
    • Ohio
      • Columbus, Ohio, 미국, 43210
        • Ohio State University Comprehensive Cancer Center
        • 연락하다:
        • 수석 연구원:
          • Xiaochen Zhang, PhD

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 지지 요법
  • 할당: 무작위화되지 않음
  • 중재 모델: 순차적 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
다른: 설문지 관리
보조 연구
절차: 생체 시료 수집
소변 및 혈액 샘플 수집을 수행합니다.
다른 이름들:
  • 생물학적 샘플 수집
  • 생체 표본 수집
  • 표본 수집
  • 샘플 수집
다른: Aerobic Exercise
Participate in moderate-intensity aerobic physical activity
다른 이름들:
  • 유산소 활동
다른: Dietary Intervention
Adhere to a personalized diet
다른 이름들:
  • 식이 수정
  • 개입, 식이요법
  • 영양 개입
다른: Discussion
Participate in a focus group
다른 이름들:
  • 논의하다
다른: Internet-Based Intervention
Complete self-paced web-based lifestyle program modules
다른: Resistance Training
Participate in resistance training
다른 이름들:
  • 체력 훈련
다른: Supportive Care
Receive access to online resources
다른 이름들:
  • 지지 요법
  • 증상 관리
  • 치료, 지지
다른: Supportive Care
Attend virtual group sessions
다른 이름들:
  • 지지 요법
  • 증상 관리
  • 치료, 지지
실험적: 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.
다른: 설문지 관리
보조 연구
절차: 생체 시료 수집
소변 및 혈액 샘플 수집을 수행합니다.
다른 이름들:
  • 생물학적 샘플 수집
  • 생체 표본 수집
  • 표본 수집
  • 샘플 수집
다른: Aerobic Exercise
Participate in moderate-intensity aerobic physical activity
다른 이름들:
  • 유산소 활동
다른: Dietary Intervention
Adhere to a personalized diet
다른 이름들:
  • 식이 수정
  • 개입, 식이요법
  • 영양 개입
다른: Discussion
Participate in a focus group
다른 이름들:
  • 논의하다
다른: Internet-Based Intervention
Complete self-paced web-based lifestyle program modules
다른: Resistance Training
Participate in resistance training
다른 이름들:
  • 체력 훈련
다른: Supportive Care
Receive access to online resources
다른 이름들:
  • 지지 요법
  • 증상 관리
  • 치료, 지지
다른: Supportive Care
Attend virtual group sessions
다른 이름들:
  • 지지 요법
  • 증상 관리
  • 치료, 지지
다른: Goal Setting
Set goals for behavioral changes
다른: Medical Device Usage and Evaluation
Wear a physical activity tracker
행동: Smartphone Application-based Intervention
Receive access to the Fitbit app
다른 이름들:
  • Smartphone App-based Intervention
  • Smartphone Intervention
  • Smartphone-based Intervention
절차: Tailored Intervention
Receive JITAI tailored resource components

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Preferences, needs and satisfaction (Aim 1a)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Ohio State University Comprehensive Cancer Center

협력자

American Association for Cancer Research

수사관

  • 수석 연구원: Xiaochen Zhang, PhD, Ohio State University Comprehensive Cancer Center

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

유용한 링크

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 10월 10일

기본 완료 (추정된)

2027년 12월 31일

연구 완료 (추정된)

2027년 12월 31일

연구 등록 날짜

최초 제출

2026년 7월 20일

QC 기준을 충족하는 최초 제출

2026년 7월 20일

처음 게시됨 (실제)

2026년 7월 23일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 7월 23일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 7월 20일

마지막으로 확인됨

2026년 7월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • OSU-26016
  • NCI-2026-05189 (레지스트리 식별자: CTRP (Clinical Trial Reporting Program))
  • STUDY20252952

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

미국에서 제조되어 미국에서 수출되는 제품

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다