EDITS Pilot Study for Gynecologic Cancer Survivors

Rutgers, The State University of New Jersey

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Conditions

Gynecologic Cancer

Interventions

Exercise and diet education and instructionBEHAVIORAL

1:1 or small group sessions consisting of educational materials and exercise instruction.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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).

Locations (1)

Rutgers, Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

Outcomes

Primary Outcomes

Participant retention

Participant retention will be tracked through completion of the intervention, assessments, and questionnaires.

Time frame: Baseline

Participant retention

Participant retention will be tracked through completion of the intervention, assessments, and questionnaires.

Time frame: Week 13

Participant attendance

The research staff will track participant attendance to the intervention sessions.

Time frame: Baseline

Participant attendance

The research staff will track participant attendance to the intervention sessions.

Time frame: Week 13

Acceptability

Satisfaction will be assessed using Internet Evaluation and Utility Questionnaire

Time frame: Week 13

Secondary Outcomes

Physical activity (objective)

Participants will where an activity tracker to measure minutes of physical activity, intensity, and steps.

Time frame: Baseline and Week 13

Physical activity (self-report)

Physical activity intensity and duration will be measured with an adapted version of the Godin Shephard Leisure Time Physical Activity Questionnaire

Time frame: Baseline and Week 13

Healthy Dietary Practices

A food diary for 24 hours will be tracked using the NCI's Automated Self-Administered 24 hours tool

Data from ClinicalTrials.gov

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