Exercise and Diet Intervention opTimized for Gynecologic Cancer Survivors (EDITS Study): Development, Feasibility, and Acceptability
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Participant attendance
研究概览
简要总结
The main goal in this project is to develop and pilot test a 12-week multiple health behavior change (MHBC) intervention for feasibility and acceptability. The pilot study will be guided by Multiphase Optimization Strategy (MOST) framework, which uses highly efficient experiments to systematically test and compare intervention components' or component levels' individual and combined effects. The goal of the MOST framework is to balance effectiveness with affordability, sustainability, and efficiency.
详细描述
Aim 1: Develop the MHBC intervention with components optimized for gynecologic cancer survivors (GCS). 1a) To develop the intervention components for physical activity and healthy dietary practices, one-on-one interviews will be conducted with stakeholders including GCS (n≈30; until thematic saturation) and gynecologic oncology clinicians (n≈10; until thematic saturation). Clinician is operationalized as any cancer care health professional with direct gynecologic patient contact. Using directed content analysis, it is anticipated that reasons for low uptake in MHBC interventions and gain insight on preferences for intervention components and characteristics such as component delivery (simultaneous vs. sequential), frequency of contact, delivery modality (in-person vs. remote), and support materials (e.g., workbooks and logs) will be identified. The identified factors and preferences will be mapped onto theoretical tenets and taxonomy to develop intervention components. 1b) To refine intervention design and components we will elicit GCS stakeholder input using a cross-sectional study design with an online questionnaire. A questionnaire will be administered to the same 30 GCS from Study 1a to obtain feedback identify intervention preferences.
Aim 2: Determine the feasibility of the MHBC intervention and acceptability of components optimized among GCS. We will evaluate feasibility and acceptability of the 12-week MHBC intervention with 16 GCS. To determine feasibility, the following will be used: number of intervention participants who enroll, those who complete the study, those complete follow-up measures at Week 13, and attendance. Based on previous MHBC interventions with GCS, it is anticipated that 30% will enroll, 85% will complete the intervention, 75% will complete measures at Week 13, and > 70% of the sessions will be attended. To determine acceptability, satisfaction with intervention components at Week 13 will be measured. It is predicted that 86% intervention group will report high satisfaction (cutoff score: > 5 out 7).
Aim 3 (exploratory): Assess the preliminary effects of the intervention on behavioral and cardiometabolic outcomes. The preliminary effects of the intervention on behavioral outcomes including physical activity, healthy dietary practices, HRQOL and cardiometabolic outcomes including weight, waist circumference, body composition (% body fat), and blood pressure will be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Only women will be eligible if they meet the following criteria: :
- •18 years old
- •A confirmed diagnosis of gynecologic cancer, Stage > I
- •Have completed treatment within five years prior to study commencement and hormonal replacement therapy is acceptable
- •Are not active, defined as engaging in < 150 minutes of moderate-to-vigorous physical activity per week
- •Have a potential unhealthy diet, defined as consuming < 2.5 servings of fruits and vegetables per day, or fast foods more than once per week over the past month
- •Are able to converse in and understand English
排除标准
- •Women will be excluded if they meet any of the following criteria:
- •Respiratory, joint, or cardiovascular problems precluding physical activity as per physical activity safety screening questionnaire;
- •Metastatic disease
- •Planned elective surgery during the duration of the intervention and/or follow-up that would interfere with participation (e.g., reconstructive surgery).
结局指标
主要结局
Participant attendance
时间窗: Week 13
The research staff will track participant attendance to the intervention sessions.
Acceptability
时间窗: Week 13
Satisfaction will be assessed using Internet Evaluation and Utility Questionnaire
Participant retention
时间窗: Week 13
Participant retention will be tracked through completion of the intervention, assessments, and questionnaires.
次要结局
- Height (m)(Baseline and Week 13)
- Physical activity (objective)(Baseline and Week 13)
- Healthy Dietary Practices(Baseline and Week 13)
- Physical activity (self-report)(Baseline and Week 13)
- Weight (kg)(Baseline and Week 13)
- Health-related Quality of Life(Baseline and Week 13)
- Exercise Self-efficacy(Baseline and Week 13)
- Outcome expectations(Baseline and Week 13)
- Facilitators and impediments(Baseline and Week 13)
- Blood pressure(Baseline and Week 13)
- Height, weight, waist and hip circumference, and body composition(Baseline and Week 13)
- Waist and hip circumferences (m)(Baseline and Week 13)
- Body composition(Baseline and Week 13)
- 6-minute walk test (m)(Baseline and Week 13)
- Arm curl test (quantity)(Baseline and Week 13)
- Chair sit-to-stand (quantity)(Baseline and Week 13)
研究者
Angela Jacqueline Fong, PhD
Instructor of Medicine at Rutgers Cancer Institute of New Jersey
Rutgers, The State University of New Jersey