RECRUITING

Trial of Exercise and Lifestyle for Women With Ovarian and Endometrial Cancer

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

An anticipated 200 women with newly diagnosed ovarian and endometrial cancer scheduled to receive chemotherapy (adjuvant chemotherapy after surgery or neoadjuvant chemotherapy before surgery) will be recruited from Smilow Cancer Hospital Network at Yale Cancer Center (YCC) and Sylvester Comprehensive Cancer Center (SCCC) at University of Miami. Participants will be randomized to an exercise and medical nutrition intervention arm with weekly counseling sessions throughout chemotherapy, or a control arm. Study assessments will be conducted at baseline, post-chemotherapy/end of intervention and at 1-year post diagnosis. Women who are prescribed neoadjuvant therapy will have additional assessments prior to surgery. Data required to calculate the primary endpoint (relative dose intensity of chemotherapy) will be abstracted from the medical record directly following each chemotherapy session.

Official Title

Trial of Exercise and Lifestyle (TEAL) for Women With Ovarian and Endometrial Cancer

Quick Facts

Study Start:2023-04-19
Study Completion:2027-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05761561

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * have a diagnosis of epithelial ovarian cancer, fallopian tube or primary peritoneal carcinoma, stage I-IV OR have a diagnosis of advanced or metastatic endometrial carcinoma (including carcinosarcoma) AND their treatment regimen includes carboplatin and taxane (or equivalent)
  2. * be scheduled to receive at least 6 cycles of neoadjuvant or adjuvant chemotherapy
  3. * be physically able to walk without a walking aid (e.g. cane or walker)
  4. * be able to complete forms, understand instructions and read intervention book in English or Spanish
  5. * agree to be randomly assigned to either group
  6. * have clearance from oncologist to participate
  7. * be ≥ 18 years of age
  1. * having already completed a 2nd cycle of chemotherapy
  2. * already practicing dietary (\>7 servings of fruits and vegetables per day) OR physical activity guidelines (≥150 min per week of moderate to vigorous exercise and resistance training two times per week) since diagnosis
  3. * pregnancy or intention to become pregnant
  4. * recent (past year) stroke/myocardial infarction or congestive heart failure/ejection fraction \<40%
  5. * presence of dementia or major psychiatric disease
  6. * in active treatment including target or biologic therapies for any other cancer (excluding hormone therapy treatments)
  7. * receiving external beam radiation

Contacts and Locations

Study Locations (Sites)

Yale University
New Haven, Connecticut, 06511
United States
University of Miami
Miami, Florida, 33136
United States

Collaborators and Investigators

Sponsor: Yale University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-04-19
Study Completion Date2027-06

Study Record Updates

Study Start Date2023-04-19
Study Completion Date2027-06

Terms related to this study

Additional Relevant MeSH Terms

  • Ovarian Cancer