EDITS Pilot Study for Gynecologic Cancer Survivors

NCT05466916 | Withdrawn DMC

• 2 other identifiers: Pro2022000863CINJ 132205
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Gynecologic Cancer

Keywords

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

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (16)

• Physical activity (objective)

  Baseline and Week 13

• Physical activity (self-report)

  Baseline and Week 13

• Healthy Dietary Practices

  Baseline and Week 13

• Health-related Quality of Life

  Baseline and Week 13

• Exercise Self-efficacy

  Baseline and Week 13

Study Arms (1)

Exercise and diet education and instruction

EXPERIMENTAL

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

Interventions

Exercise and diet education and instruction BEHAVIORAL

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

Exercise and diet education and instruction

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: A confirmed diagnosis of gynecologic cancer, Stage \> I
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Only women will be eligible if they meet the following criteria: :
• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead

Study Sites (1)

Rutgers, Cancer Institute of New Jersey

New Brunswick, New Jersey, 08901, United States

Location

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise; Nutrition Assessment; Educational Status

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health; Socioeconomic Factors; Population Characteristics

Study Officials

• Angela J Fong, PhD

  Rutgers Cancer Institute of New Jersey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor of Medicine at Rutgers Cancer Institute of New Jersey

Model Details: 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.

Study Record Dates

• First Submitted: July 11, 2022
• First Posted: July 20, 2022
• Study Start: July 20, 2022
• Primary Completion: April 14, 2023
• Study Completion: April 14, 2023
• Last Updated: October 13, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)