EDITS Pilot Study for Gynecologic Cancer Survivors

• ClinicalTrials.gov Identifier: NCT05466916
• Recruitment Status: Recruiting
• First Posted: July 20, 2022
• Last Update Posted: January 4, 2023
• Sponsor: Rutgers, The State University of New Jersey
• Information provided by (Responsible Party): Angela Jacqueline Fong, PhD, Rutgers, The State University of New Jersey

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Gynecologic Cancer	Behavioral: Exercise and diet education and instruction	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• 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.
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Exercise and Diet Intervention opTimized for Gynecologic Cancer Survivors (EDITS Study): Development, Feasibility, and Acceptability
• Actual Study Start Date: July 20, 2022
• Estimated Primary Completion Date: July 31, 2023
• Estimated Study Completion Date: July 31, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Participant retention [ Time Frame: Baseline ]
   Participant retention will be tracked through completion of the intervention, assessments, and questionnaires.
2. Participant retention [ Time Frame: Week 13 ]
   Participant retention will be tracked through completion of the intervention, assessments, and questionnaires.
3. Participant attendance [ Time Frame: Baseline ]
   The research staff will track participant attendance to the intervention sessions.
4. Participant attendance [ Time Frame: Week 13 ]
   The research staff will track participant attendance to the intervention sessions.
5. Acceptability [ Time Frame: Week 13 ]
   Satisfaction will be assessed using Internet Evaluation and Utility Questionnaire

Secondary Outcome Measures :

1. Physical activity (objective) [ Time Frame: Baseline and Week 13 ]
   Participants will where an activity tracker to measure minutes of physical activity, intensity, and steps.
2. Physical activity (self-report) [ Time Frame: Baseline and Week 13 ]
   Physical activity intensity and duration will be measured with an adapted version of the Godin Shephard Leisure Time Physical Activity Questionnaire
3. Healthy Dietary Practices [ Time Frame: Baseline and Week 13 ]
   A food diary for 24 hours will be tracked using the NCI's Automated Self-Administered 24 hours tool
4. Health-related Quality of Life [ Time Frame: Baseline and Week 13 ]
   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
5. Exercise Self-efficacy [ Time Frame: Baseline and Week 13 ]
   To assess confidence in one's ability to exercise at a moderate intensity three times per week using the adapted Exercise Self-Efficacy Scale
6. Outcome expectations [ Time Frame: Baseline and Week 13 ]
   To assess the expectations about exercising regularly using the Multidimensional Outcome Expectation for Exercise Scale
7. Facilitators and impediments [ Time Frame: Baseline and Week 13 ]
   Open-ended questions asking participants to list any other facilitators and impediments to engagement in the intervention and multiple health behaviors
8. Blood pressure [ Time Frame: Baseline and Week 13 ]
   Systolic and diastolic blood pressure will be measured with an automated cuff.
9. Height (m) [ Time Frame: Baseline and Week 13 ]
   Medical scale with a height ruler.
10. Height, weight, waist and hip circumference, and body composition [ Time Frame: Baseline and Week 13 ]
    Scale, measuring tape, and bioelectric impedance analysis scale
11. Weight (kg) [ Time Frame: Baseline and Week 13 ]
    Scale
12. Waist and hip circumferences (m) [ Time Frame: Baseline and Week 13 ]
    Measuring tape at the smallest and largest portions of the torso.
13. Body composition [ Time Frame: Baseline and Week 13 ]
    Percent of body fat (%) and lean muscle mass )kg) measured using a bioimpedance analysis scale.
14. 6-minute walk test (m) [ Time Frame: Baseline and Week 13 ]
    Meters walked in 6-minutes as proxy for cardiovascular fitness.
15. Chair sit-to-stand (quantity) [ Time Frame: Baseline and Week 13 ]
    The total number of times an individual transitions from seated position to a standing position in 30-seconds. Measure of lower body strength
16. Arm curl test (quantity) [ Time Frame: Baseline and Week 13 ]
    Number of times an individual can curl a 5lb weight using their dominant arm in 30-seconds. Measure of upper body strength

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: A confirmed diagnosis of gynecologic cancer, Stage > I
• Accepts Healthy Volunteers: No

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).

Contacts and Locations

Contacts

Contact: Angela J Fong, PhD; 732-235-8076; angela.fong@rutgers.edu

Locations

United States, New Jersey

Rutgers, Cancer Institute of New Jersey; Recruiting

New Brunswick, New Jersey, United States, 08901

Contact: Angela J Fong, PhD 732-235-8076 angela.fong@rutgers.edu

Sponsors and Collaborators

Rutgers, The State University of New Jersey

Investigators

• Principal Investigator: Angela J Fong, PhD; Rutgers Cancer Institute of New Jersey

More Information

• Responsible Party: Angela Jacqueline Fong, PhD, Instructor of Medicine at Rutgers Cancer Institute of New Jersey, Rutgers, The State University of New Jersey
• ClinicalTrials.gov Identifier: NCT05466916
• Other Study ID Numbers: Pro2022000863; CINJ 132205 ( Other Identifier: Rutgers, The State University of New Jersey )
• First Posted: July 20, 2022
• Last Update Posted: January 4, 2023
• Last Verified: January 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Angela Jacqueline Fong, PhD, Rutgers, The State University of New Jersey:

Gynecologic Cancer; Multiple health behavior change; Optimization; Cancer survivorship; Physical activity; Diet