EDITS Pilot Study for Gynecologic Cancer Survivors

Gynecologic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05466916
• Other study ID #: Pro2022000863
• Secondary ID: CINJ 132205
• Status: Withdrawn
• Phase: N/A
• Start date: July 20, 2022
• Est. completion date: April 14, 2023

Study information

• Verified date: October 2023
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 14, 2023
• Est. primary completion date: April 14, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Gynecologic Cancer

Intervention

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

Locations

Country	Name	City	State
United States	Rutgers, Cancer Institute of New Jersey	New Brunswick	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participant retention	Participant retention will be tracked through completion of the intervention, assessments, and questionnaires.	Baseline
Primary	Participant retention	Participant retention will be tracked through completion of the intervention, assessments, and questionnaires.	Week 13
Primary	Participant attendance	The research staff will track participant attendance to the intervention sessions.	Baseline
Primary	Participant attendance	The research staff will track participant attendance to the intervention sessions.	Week 13
Primary	Acceptability	Satisfaction will be assessed using Internet Evaluation and Utility Questionnaire	Week 13
Secondary	Physical activity (objective)	Participants will where an activity tracker to measure minutes of physical activity, intensity, and steps.	Baseline and Week 13
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Outcome expectations	To assess the expectations about exercising regularly using the Multidimensional Outcome Expectation for Exercise Scale	Baseline and Week 13
Secondary	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
Secondary	Blood pressure	Systolic and diastolic blood pressure will be measured with an automated cuff.	Baseline and Week 13
Secondary	Height (m)	Medical scale with a height ruler.	Baseline and Week 13
Secondary	Height, weight, waist and hip circumference, and body composition	Scale, measuring tape, and bioelectric impedance analysis scale	Baseline and Week 13
Secondary	Weight (kg)	Scale	Baseline and Week 13
Secondary	Waist and hip circumferences (m)	Measuring tape at the smallest and largest portions of the torso.	Baseline and Week 13
Secondary	Body composition	Percent of body fat (%) and lean muscle mass )kg) measured using a bioimpedance analysis scale.	Baseline and Week 13
Secondary	6-minute walk test (m)	Meters walked in 6-minutes as proxy for cardiovascular fitness.	Baseline and Week 13
Secondary	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
Secondary	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