EDITS Pilot Study for Gynecologic Cancer Survivors

NCT ID: NCT05466916

Last Updated: 2023-10-13

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-20
• Study Completion Date: 2023-04-14

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.

Conditions

Gynecologic Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Exercise and diet education and instruction

The intervention will be 12 weeks in duration. The five intervention components (e.g., educational sessions and instructional sessions) will be supervised. Research staff will conduct the intervention. Participants will be instructed to gradually aim for 30 minutes of physical activity for five days per week by Week 12 Participants will also aim for improved healthy dietary practices including \> 200 grams/day (g/d) of fruits and vegetables, \> 15 g/d of fiber (whole grains and beans), \< 250 g/d of sugar-sweetened drinks and lower percent of total kcal from fast foods18 by Week 12. Sessions will be about 35- to 50-minutes in duration and be structured as follows: (a) review of previous session and an opportunity to ask questions (\~5 minutes); (b) presentation of content (20- to 30-minutes); (c) opportunity for questions (\~5 minutes); and (d) preview of next sessions and research activity reminders (2- to 3-minutes).

Group Type: EXPERIMENTAL

Exercise and diet education and instruction

Intervention Type: BEHAVIORAL

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

Interventions

Exercise and diet education and instruction

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

Intervention Type: BEHAVIORAL

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Rutgers, The State University of New Jersey

OTHER

Sponsor Role: lead

Responsible Party

Angela Jacqueline Fong, PhD

Instructor of Medicine at Rutgers Cancer Institute of New Jersey

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Angela J Fong, PhD

Role: PRINCIPAL_INVESTIGATOR

Rutgers Cancer Institute of New Jersey

Locations

Rutgers, Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

Countries

United States

Other Identifiers

CINJ 132205

Identifier Type: OTHER

Identifier Source: secondary_id

Pro2022000863

Identifier Type: -

Identifier Source: org_study_id