Rural Women Connecting for Better Health

Breast Cancer Clinical Trial

Official title:

Group Phone-Based Weight Control for Rural Breast Cancer Survivors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01441011
• Other study ID #: 12633
• Secondary ID: 1R01CA155014-01A
• Status: Completed
• Phase: N/A
• First received: September 23, 2011
• Last updated: November 22, 2016
• Start date: August 2011
• Est. completion date: October 2015

Study information

• Verified date: November 2016
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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 activity are common after diagnosis and also increase the likelihood of breast cancer recurrence and death. Rural women suffer from health disparities in breast cancer diagnosis and treatment. Women of the most rural counties also have the highest prevalence of obesity compared to urban women. To address these disparities, the overarching objective of this proposal is to develop a clinically effective and cost efficient strategy for delivering a weight control intervention to rural breast cancer survivors. Group phone-based treatment via conference call is a novel treatment delivery approach that the investigators have shown to be effective for initial weight loss among rural breast cancer survivors and more effective than the standard individual phone-based approach among rural women. This innovative method of providing group treatment addresses access barriers in rural areas and may be especially ideal for rural breast cancer survivors because it provides social support in conjunction with a level of anonymity. However, the impact of group phone counseling during extended care for weight loss maintenance beyond 6 months remains unknown. Weight loss maintenance is the more challenging phase of treatment when weight regain is common, and this regain presents a potential risk for breast cancer recurrence. This randomized controlled trial will evaluate the effects of group phone-based treatment for weight loss maintenance among rural breast cancer survivors, compared to an established mail-based education comparison condition, subsequent to a 6 month group phone-based weight loss phase for both conditions. In addition to the intervention impact on weight loss maintenance, the study will provide estimates of incremental cost-effectiveness per kg loss between the two conditions and the impact on secondary outcomes including quality of life, breast cancer risk biomarkers, dietary intake, and physical activity.

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 recommended, including 2 pre-packaged entrees, five one-cup servings of fruits and vegetables and meal replacement shakes (provided free of charge)

• Physical activity program program recommended, beginning with 15 minutes per day, 3 days a week, working toward a goal of 225 minutes a week

• Experienced group counselor facilitates all sessions

Phase 2 - Weight Loss Maintenance (6-18 months)

• Participants randomized to either group phone counseling or mail-based comparison with no phone counseling

• Weight loss maintenance group condition includes 26 bi-weekly phone sessions, while mail-based comparison includes 26 bi-weekly newsletters in the mail

• Focus is on problem-solving

Phase 3 - Transition to Self-Reliance (18-24 months)

• Lasts from 18-24 months

• No sessions or newsletter mailings

• Participants are encouraged to continue to self-monitor throughout this period

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. completion date: October 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A to 75 Years

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Obesity

Intervention

Behavioral:
• Group phone counseling
Bi-weekly phone counseling sessions from 6 - 18 months
• Newsletter
Bi-weekly newsletter mailings from 6 - 18 months

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
University of Kansas Medical Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight loss maintenance	Examine the impact of group phone-based treatment on weight loss maintenance from 6 to 18 months, compared to a mail-based education COMPARISON condition, following a 6-month weight loss phase among obese rural breast cancer survivors.	6 - 18 months	No
Secondary	Quality of life	Compare the effects of treatment conditions on aspects of quality of life important for breast cancer survivorship, including general physical, social, and emotional well-being, fatigue, arthralgia, lymphedema symptoms, menopausal symptoms, and depressive symptoms.	Baseline and 6, 12, 18, and 24 months	No
Secondary	Breast cancer risk biomarkers	Examine the association of weight change with changes in selected breast cancer risk biomarkers, including bioavailable estradiol, testosterone, and fasting insulin. Examine whether modulation of biomarkers is sustained during weight loss maintenance.	Baseline and 6 and 18 months	No
Secondary	Cost effectiveness	Compare the incremental cost-effectiveness of weight loss maintenance (kg below baseline) between group and control conditions. Costs include fixed and variable provider costs (facility, time, phone charges, supplies) and fixed and variable participant costs (time, out-of-pocket expenses).	18 months	No

External Links

•   National Cancer Institute: Cancer Survivorship Research