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Group Phone-Based Weight Control for Rural Breast Cancer Survivors

75 Years
Open (Enrolling)
Breast Cancer, Obesity

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Trial Information

Group Phone-Based Weight Control for Rural Breast Cancer Survivors

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

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

- Any cardiac or pulmonary disease preventing participation

- Treatment for any other cancers within the past year

- Previous bariatric surgery

Type of Study:


Study Design:

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

Outcome Measure:

Weight loss maintenance

Outcome Description:

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.

Outcome Time Frame:

6 - 18 months

Safety Issue:


Principal Investigator

Christie Befort, Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Kansas


United States: Federal Government

Study ID:




Start Date:

August 2011

Completion Date:

May 2016

Related Keywords:

  • Breast Cancer
  • Obesity
  • weight loss
  • breast cancer
  • obesity
  • overweight
  • rural women
  • community based
  • Secondary Prevention
  • Breast Neoplasms
  • Obesity



University of Kansas Medical Center Kansas City, Kansas  66160-7353