Status:
COMPLETED
Exercise and Healthy Diet or Standard Care in Patients in Remission From Stage I or Stage II Endometrial Cancer
Lead Sponsor:
Case Comprehensive Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Endometrial Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
RATIONALE: Participating in a diet and exercise program may improve the quality of life of overweight and obese patients who are in remission from endometrial cancer. PURPOSE: This randomized phase I...
Detailed Description
PRIMARY OBJECTIVE: \* To reduce morbidity and early mortality in endometrial cancer (EC) survivors through obesity management. SECONDARY OBJECTIVES: * To expand and refine a previous pilot study of...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed stage I or II (early) endometrial carcinoma
- Diagnosed within the past 3 years
- Underwent prior surgery consisting of a total abdominal hysterectomy and bilateral salpingo-oophorectomy
- No evidence of disease
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- BMI ≥ 25 (overweight/obese)
- Medical clearance from primary care physician
- Approved for contact by treating gynecologic oncologist
- At least a 6th-grade reading level to complete significant reading and homework
- No severe psychiatric illness (e.g., schizophrenia, bipolar disorder) or major depression (Beck Depression Inventory \> 29) that needs more aggressive, problem-focused interventions
- No dementia or cognitive deficits
- No pre-existing medical conditions that would be a barrier for participation in unsupervised walking
- No participation in a structured weight loss or exercise program in the past 6 months
- Must agree to and be available for longitudinal follow-up assessments
- Non-English speakers may bring an English-speaking person to all group sessions and visits
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Exclusion
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT00732173
Start Date
July 1 2008
End Date
March 1 2011
Last Update
February 8 2013
Active Locations (1)
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1
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5065