Clinical trial · Interventional
EDITS Pilot Study for Gynecologic Cancer Survivors
Exercise and Diet Intervention opTimized for Gynecologic Cancer Survivors (EDITS Study): Development, Feasibility, and Acceptability
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study was never initiated and no participants were enrolled.
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gynecologic Cancer | Malignant Female Reproductive System Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Exercise and diet education and instruction | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Exercise and diet education and instruction
- description
- 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).
- interventionNames
- Behavioral: Exercise and diet education and instruction
Primary outcomes (5)
- measure
- Participant retention
- timeFrame
- Baseline
- description
- Participant retention will be tracked through completion of the intervention, assessments, and questionnaires.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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).
References
Publications (0)
Data not yet available