Clinical trial NCT05466916: EDITS Pilot Study for Gynecologic Cancer Survivors
Official title: Exercise and Diet Intervention opTimized for Gynecologic Cancer Survivors (EDITS Study): Development, Feasibility, and Acceptability
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Gynecologic Cancer
Keywords: Gynecologic Cancer
Multiple health behavior change
Optimization
Cancer survivorship
Physical activity
Diet
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
First posted: 2022-07-20
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: In Aims 2 and 3, a single-arm, pre-/post-study design will be used to assess feasibility and acceptability, and preliminary effects of the intervention.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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).

Primary outcomes:
measure: Participant retention
timeFrame: Baseline
measure: Participant retention
timeFrame: Week 13
measure: Participant attendance
timeFrame: Baseline
measure: Participant attendance
timeFrame: Week 13
measure: Acceptability
timeFrame: Week 13
Secondary outcomes:
measure: Physical activity (objective)
timeFrame: Baseline and Week 13
measure: Physical activity (self-report)
timeFrame: Baseline and Week 13
measure: Healthy Dietary Practices
timeFrame: Baseline and Week 13
measure: Health-related Quality of Life
timeFrame: Baseline and Week 13
measure: Exercise Self-efficacy
timeFrame: Baseline and Week 13
measure: Outcome expectations
timeFrame: Baseline and Week 13
measure: Facilitators and impediments
timeFrame: Baseline and Week 13
measure: Blood pressure
timeFrame: Baseline and Week 13
measure: Height (m)
timeFrame: Baseline and Week 13
measure: Height, weight, waist and hip circumference, and body composition
timeFrame: Baseline and Week 13
measure: Weight (kg)
timeFrame: Baseline and Week 13
measure: Waist and hip circumferences (m)
timeFrame: Baseline and Week 13
measure: Body composition
timeFrame: Baseline and Week 13
measure: 6-minute walk test (m)
timeFrame: Baseline and Week 13
measure: Chair sit-to-stand (quantity)
timeFrame: Baseline and Week 13
measure: Arm curl test (quantity)
timeFrame: Baseline and Week 13
Other outcomes:
Locations:
city: New Brunswick
country: United States
facility: Rutgers, Cancer Institute of New Jersey
state: New Jersey
Study officials:
affiliation: Rutgers Cancer Institute of New Jersey
name: Angela J Fong, PhD
role: PRINCIPAL_INVESTIGATOR
References: