NCT00774371

Brief Summary

Overweight or obesity is an established negative prognostic factor in both premenopausal and postmenopausal breast cancer. Several mechanisms have been proposed to explain the adverse effect of excess body fat on prognosis following the diagnosis of breast cancer, including increased circulating sex hormones, insulin, leptin, and various growth factors. Results from previous studies suggest that specific strategies can facilitate weight reduction and maintenance of weight loss in this target population. This randomized clinical trial will recruit 253 overweight or obese women who have been previously treated for early stage breast cancer and will test whether a multifaceted approach to promoting healthy weight management can achieve the goal of weight loss and maintenance. Additionally, this study tests whether weight loss is associated with changes in biological and psychosocial factors, including eating attitudes and behaviors and health-related quality of life. The intervention incorporates cognitive-behavioral therapy, increased physical activity, diet modification to facilitate a modest reduction in energy intake, and strategies to improve body image and self-acceptance. This approach and intervention have been pilot-tested with breast cancer survivors in a developmental project, which resulted in the intervention group losing significantly more weight than the wait-list control group. Study Aims include: testing whether an intervention that emphasizes increased physical activity and individualized diet modification to promote an energy imbalance is associated with a greater degree of weight loss and maintenance of that loss over an 18-month time period; describing the effect of the intervention on hormones and growth factors; describing the relationships between body weight and weight reduction and measures of selected psychosocial factors. Measurements of hormonal and psychosocial factors in this study will provide insight into the responsiveness of these factors to weight loss in overweight or obese breast cancer survivors, which will provide an indication of the degree of clinical benefit that is achieved with the intervention efforts. Results from this study may enable the development of broader efforts transferable to clinical practice and public health, and thus, may ultimately have a substantial effect on the risk for recurrence and long-term survival of the estimated 1.98 million breast cancer survivors in the U.S. today.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
253

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
Completed

Started Jan 2005

Typical duration for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

October 16, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 17, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

November 30, 2023

Status Verified

November 1, 2023

Enrollment Period

4.1 years

First QC Date

October 16, 2008

Last Update Submit

November 27, 2023

Conditions

Breast Cancer

Keywords

OverweightObeseBreast cancer survivorsWeight lossPhysical activityExerciseCognitive behavioral therapy

Outcome Measures

Primary Outcomes (1)

  • Weight loss

    2 years

Secondary Outcomes (1)

  • Increase in physical activity levels

    2 years

Study Arms (1)

1

EXPERIMENTAL

The intervention program consists of group sessions provided according to the following schedule: weekly for 4 months, every other week for two months, and follow-up monthly sessions through 18 months of active subject participation. The time points for data collection from all subjects are baseline, 6 months, and 18 months. The group sessions offered to the treatment study arm are closed-group contingents with an average of 12-15 women assigned to each group.

Behavioral: Cognitive behavioral therapy CBT) for weight loss

Interventions

Cognitive behavioral therapy CBT) for weight lossBEHAVIORAL

The intervention program emphasizes regular physical activity, healthy eating, and psychological components within the structure of CBT for obesity. The physical activity component emphasizes planned aerobic exercise, increased physical activity and strength training. A deficit of 500-1000 kcal/day is the recommended level of dietary modification to promote weight loss and maintenance. Group sessions are held weekly for 4 months, every other week for two months, and monthly sessions through 18 months. Data are collected at baseline, 6 months, and 18 months. Wait-list group subjects will receive general contact without specific reference to weight management topics through a 24-month period of data collection and will then be provided intervention materials in a seminar format.

1

Eligibility Criteria

Age18 Years - 90 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed with Stage I-IIIA breast cancer within the previous 10 years
  • Have completed initial treatments (i.e., surgery, adjuvant chemotherapy, radiation therapy)
  • Have initial BMI \>25.0 kg/m2
  • A minimum of 15 kg over ideal weight
  • Willingness and ability to attend group meetings and to maintain contact with the investigators for 18 months
  • Ability to provide dietary and exercise data by telephone at prescribed intervals.

You may not qualify if:

  • Inability to participate in physical activity because of severe disability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Moores UCSD Cancer Center

La Jolla, California, 92093, United States

Location

Related Publications (1)

  • Rock CL, Pande C, Flatt SW, Ying C, Pakiz B, Parker BA, Williams K, Bardwell WA, Heath DD, Nichols JF. Favorable changes in serum estrogens and other biologic factors after weight loss in breast cancer survivors who are overweight or obese. Clin Breast Cancer. 2013 Jun;13(3):188-95. doi: 10.1016/j.clbc.2012.12.002. Epub 2013 Jan 29.

    PMID: 23375717DERIVED

Related Links

MeSH Terms

Conditions

Breast NeoplasmsOverweightObesityWeight LossMotor Activity

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight ChangesBehavior

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Cheryl L. Rock, PhD, RD

    University of California, San Diego

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Weight list control group was the comparison to the immediate treatment group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 16, 2008

First Posted

October 17, 2008

Study Start

January 1, 2005

Primary Completion

February 1, 2009

Study Completion

December 1, 2009

Last Updated

November 30, 2023

Record last verified: 2023-11

Locations

US(1)