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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

2026年7月20日 更新者：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.

調査の概要

状態

まだ募集していません

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (推定)

90

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

  • アメリカ
    • Ohio
      • Columbus、Ohio、アメリカ、43210
        • Ohio State University Comprehensive Cancer Center
        • コンタクト：
        • 主任研究者：
          • Xiaochen Zhang, PhD

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：支持療法
  • 割り当て：非ランダム化
  • 介入モデル：順次割り当て
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
実験的：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.
他の：アンケート管理
補助研究
手順：生体標本の収集
尿と血液サンプルの採取を受けます
他の名前：
  • 生物学的サンプルの収集
  • 採取された生体試料
  • 標本収集
  • サンプル収集
他の：Aerobic Exercise
Participate in moderate-intensity aerobic physical activity
他の名前：
  • 有酸素運動
他の：Dietary Intervention
Adhere to a personalized diet
他の名前：
  • 食事の変更
  • 介入、食事
  • 栄養介入
他の：Discussion
Participate in a focus group
他の名前：
  • 議論
他の：Internet-Based Intervention
Complete self-paced web-based lifestyle program modules
他の：Resistance Training
Participate in resistance training
他の名前：
  • 筋力トレーニング
他の：Supportive Care
Receive access to online resources
他の名前：
  • 支持療法
  • 症状管理
  • セラピー、サポーティブ
他の：Supportive Care
Attend virtual group sessions
他の名前：
  • 支持療法
  • 症状管理
  • セラピー、サポーティブ
実験的：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.
他の：アンケート管理
補助研究
手順：生体標本の収集
尿と血液サンプルの採取を受けます
他の名前：
  • 生物学的サンプルの収集
  • 採取された生体試料
  • 標本収集
  • サンプル収集
他の：Aerobic Exercise
Participate in moderate-intensity aerobic physical activity
他の名前：
  • 有酸素運動
他の：Dietary Intervention
Adhere to a personalized diet
他の名前：
  • 食事の変更
  • 介入、食事
  • 栄養介入
他の：Discussion
Participate in a focus group
他の名前：
  • 議論
他の：Internet-Based Intervention
Complete self-paced web-based lifestyle program modules
他の：Resistance Training
Participate in resistance training
他の名前：
  • 筋力トレーニング
他の：Supportive Care
Receive access to online resources
他の名前：
  • 支持療法
  • 症状管理
  • セラピー、サポーティブ
他の：Supportive Care
Attend virtual group sessions
他の名前：
  • 支持療法
  • 症状管理
  • セラピー、サポーティブ
他の：Goal Setting
Set goals for behavioral changes
他の：Medical Device Usage and Evaluation
Wear a physical activity tracker
行動：Smartphone Application-based Intervention
Receive access to the Fitbit app
他の名前：
  • Smartphone App-based Intervention
  • Smartphone Intervention
  • Smartphone-based Intervention
手順：Tailored Intervention
Receive JITAI tailored resource components

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Preferences, needs and satisfaction (Aim 1a)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Ohio State University Comprehensive Cancer Center

協力者

American Association for Cancer Research

捜査官

  • 主任研究者：Xiaochen Zhang, PhD、Ohio State University Comprehensive Cancer Center

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

便利なリンク

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年10月10日

一次修了 (推定)

2027年12月31日

研究の完了 (推定)

2027年12月31日

試験登録日

最初に提出

2026年7月20日

QC基準を満たした最初の提出物

2026年7月20日

最初の投稿 (実際)

2026年7月23日

学習記録の更新

投稿された最後の更新 (実際)

2026年7月23日

QC基準を満たした最後の更新が送信されました

2026年7月20日

最終確認日

2026年7月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • OSU-26016
  • NCI-2026-05189 (レジストリ識別子：CTRP (Clinical Trial Reporting Program))
  • STUDY20252952

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いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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