EDITS Pilot Study for Gynecologic Cancer Survivors

Exercise and Diet Intervention opTimized for Gynecologic Cancer Survivors (EDITS Study): Development, Feasibility, and Acceptability

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.

Study Overview

• Status: Withdrawn
• Conditions: Gynecologic Cancer
• Intervention / Treatment: Behavioral: Exercise and diet education and instruction

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • New Brunswick, New Jersey, United States, 08901
      • Rutgers, Cancer Institute of New Jersey

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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).

Behavioral: Exercise and diet education and instruction; 1:1 or small group sessions consisting of educational materials and exercise instruction.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant retention	Participant retention will be tracked through completion of the intervention, assessments, and questionnaires.	Baseline
Participant retention	Participant retention will be tracked through completion of the intervention, assessments, and questionnaires.	Week 13
Participant attendance	The research staff will track participant attendance to the intervention sessions.	Baseline
Participant attendance	The research staff will track participant attendance to the intervention sessions.	Week 13
Acceptability	Satisfaction will be assessed using Internet Evaluation and Utility Questionnaire	Week 13

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical activity (objective)	Participants will where an activity tracker to measure minutes of physical activity, intensity, and steps.	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	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	Baseline and Week 13
Health-related Quality of Life	To assess domains of health-related quality of life including Physical health-related domains include General Health, Physical Functioning, Role Physical, and Body Pain. Mental health-related scales include Vitality, Social Functioning, Role Emotional, and Mental Health using the Short Form-12	Baseline and Week 13
Exercise Self-efficacy	To assess confidence in one's ability to exercise at a moderate intensity three times per week using the adapted Exercise Self-Efficacy Scale	Baseline and Week 13
Outcome expectations	To assess the expectations about exercising regularly using the Multidimensional Outcome Expectation for Exercise Scale	Baseline and Week 13
Facilitators and impediments	Open-ended questions asking participants to list any other facilitators and impediments to engagement in the intervention and multiple health behaviors	Baseline and Week 13
Blood pressure	Systolic and diastolic blood pressure will be measured with an automated cuff.	Baseline and Week 13
Height (m)	Medical scale with a height ruler.	Baseline and Week 13
Height, weight, waist and hip circumference, and body composition	Scale, measuring tape, and bioelectric impedance analysis scale	Baseline and Week 13
Weight (kg)	Scale	Baseline and Week 13
Waist and hip circumferences (m)	Measuring tape at the smallest and largest portions of the torso.	Baseline and Week 13
Body composition	Percent of body fat (%) and lean muscle mass )kg) measured using a bioimpedance analysis scale.	Baseline and Week 13
6-minute walk test (m)	Meters walked in 6-minutes as proxy for cardiovascular fitness.	Baseline and Week 13
Chair sit-to-stand (quantity)	The total number of times an individual transitions from seated position to a standing position in 30-seconds. Measure of lower body strength	Baseline and Week 13
Arm curl test (quantity)	Number of times an individual can curl a 5lb weight using their dominant arm in 30-seconds. Measure of upper body strength	Baseline and Week 13

Collaborators and Investigators

• Sponsor: Rutgers, The State University of New Jersey
• Investigators: Principal Investigator: Angela J Fong, PhD, Rutgers Cancer Institute of New Jersey

Study record dates

Study Major Dates

• Study Start (Actual): July 20, 2022
• Primary Completion (Actual): April 14, 2023
• Study Completion (Actual): April 14, 2023

Study Registration Dates

• First Submitted: July 11, 2022
• First Submitted That Met QC Criteria: July 18, 2022
• First Posted (Actual): July 20, 2022

Study Record Updates

• Last Update Posted (Actual): October 13, 2023
• Last Update Submitted That Met QC Criteria: October 11, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Physical activity; Diet; Gynecologic Cancer; Optimization; Cancer survivorship; Multiple health behavior change
• Other Study ID Numbers: Pro2022000863; CINJ 132205 (Other Identifier: Rutgers, The State University of New Jersey)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No