Rural Women Connecting for Better Health

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Christie Befort, PhD, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier:
NCT01441011
First received: September 23, 2011
Last updated: January 14, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Breast Cancer
Obesity
Behavioral: Group phone counseling
Behavioral: Newsletter

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Group Phone-Based Weight Control for Rural Breast Cancer Survivors

Resource links provided by NLM:


Further study details as provided by University of Kansas:

Primary Outcome Measures:
  • Weight loss maintenance [ Time Frame: 6 - 18 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Quality of life [ Time Frame: Baseline and 6, 12, 18, and 24 months ] [ Designated as safety issue: No ]
    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.

  • Breast cancer risk biomarkers [ Time Frame: Baseline and 6 and 18 months ] [ Designated as safety issue: No ]
    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.

  • Cost effectiveness [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    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).


Estimated Enrollment: 208
Study Start Date: August 2011
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group (GRP) phone counseling
The group phone counseling includes 26 bi-weekly phone sessions from 6 to 18 months and focuses on group problem-solving. Women continue in the same group as in weight loss intervention phase.
Behavioral: Group phone counseling
Bi-weekly phone counseling sessions from 6 - 18 months
Active Comparator: Mail-based Comparison Condition
Participants in this group will receive a newsletter by mail every other week for 12 months starting after the initial 6 month weight loss period. The newsletters will provide problem-solving tips and will review nutrition and physical activity information.
Behavioral: Newsletter
Bi-weekly newsletter mailings from 6 - 18 months

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 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
  Eligibility

Ages Eligible for Study:   up to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01441011

Locations
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
Christie Befort, PhD
Investigators
Principal Investigator: Christie Befort, Ph.D. University of Kansas
  More Information

Additional Information:
No publications provided by University of Kansas

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Christie Befort, PhD, Assistant Professor, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier: NCT01441011     History of Changes
Other Study ID Numbers: 12633, 1R01CA155014-01A1
Study First Received: September 23, 2011
Last Updated: January 14, 2014
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by University of Kansas:
weight loss
breast cancer
obesity
overweight
rural women
community based
Secondary Prevention

Additional relevant MeSH terms:
Breast Neoplasms
Obesity
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 31, 2014