Status:
COMPLETED
Rural Women Connecting for Better Health
Lead Sponsor:
University of Kansas Medical Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Obesity
Eligibility:
FEMALE
Up to 75 years
Phase:
NA
Brief Summary
Women who are obese at breast cancer diagnosis have a 1.5 to 2.5 increased risk of recurrence and death compared to their normal weight counterparts. Moreover, weight gain and decreased physical activ...
Detailed Description
Phase 1 - Weight Loss (0-6 months) * Weekly group phone counseling sessions for all participants (12-14 women per group) via conference call for 26 consecutive weeks * Low-calorie, low-fat diet recom...
Eligibility Criteria
Inclusion
- Breast cancer patients with a BMI 27-45 kg/m2
- Diagnosis of Stage 0-IIIc disease within the past 10 years (except Stage 0, treated with mastectomy only)
- Have completed all local and systemic therapy at least 3 months prior to entry
- Have clearance from their oncologist or current medical provider to participate in a weight control study
- Must be ≤ 75 years old
- Post-menopausal
- Participants must live in a rural area
- Have access to a phone
- Able to participate in the physical activity component of the intervention, i.e., be able to walk briskly unassisted and without serious medical risk
- Weight stable within ten pounds three months prior to entry
Exclusion
- Women with insulin-dependent diabetes
- Ongoing participation in a formal weight loss program
- Ongoing use of pharmacotherapy for weight loss
- Ongoing use of medications that seriously affect weight and metabolism (e.g., steroids, phentermine)
- Positive screen for current substance abuse, major depression, or binge eating disorder
- Any cardiac or pulmonary disease preventing participation
- Treatment for any other cancers within the past year
- Previous bariatric surgery
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2015
Estimated Enrollment :
210 Patients enrolled
Trial Details
Trial ID
NCT01441011
Start Date
August 1 2011
End Date
October 1 2015
Last Update
November 23 2016
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160