Health Engagement for Rural Ohio Cancer Survivors (HERO-C)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Preferences, needs and satisfaction (Aim 1a)
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 69 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Preferences, needs and satisfaction (Aim 1a)
时间窗: 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.
Percentage of early non-responders who complete the mobile Health + ecological momentary assessment intervention (Aim 1b)
时间窗: Up to week 26
Will report the frequency, proportion, and 95% confidence intervals (CIs) of early non-responders who completed the intervention.
Percentage of all participants who complete all assessments (Aim 1c)
时间窗: Up to week 26
Will report the frequency, proportion, and 95% CIs of all participants who completed outcome assessments.
Changes in weight (Aim 2)
时间窗: 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).
Changes in muscle mass (Aim 2)
时间窗: At baseline (T0), at week 4 (T1), and at week 26 (T2)
Will estimate the preliminary effect size using linear mixed models.
Changes in metabolic profiles (Aim 2)
时间窗: At baseline (T0), at week 4 (T1), and at week 26 (T2)
Will estimate the preliminary effect size using linear mixed models.
Changes in inflammatory markers (Aim 2)
时间窗: At baseline (T0), at week 4 (T1), and at week 26 (T2)
Will estimate the preliminary effect size using linear mixed models.
Changes in behaviors (Aim 2)
时间窗: At baseline (T0), at week 4 (T1), and at week 26 (T2)
Will estimate the preliminary effect size using linear mixed models.
次要结局
未报告次要终点
研究者
Xiaochen Zhang
Principal Investigator
Ohio State University Comprehensive Cancer Center