Reducing Breast Cancer Recurrence With Weight Loss

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

692 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2015-02-28

Brief Summary

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The purpose of the ENERGY trial is to explore whether two different programs that are focused on weight management, through increased exercise and a healthy diet, are feasible, and have an impact on body weight, quality of life and fatigue. Since obesity among breast cancer survivors is associated with recurrence and other co-morbidities, those will be assessed and their impact calculated. Blood samples will be collected to enable analysis of potential mechanisms and differential response across subgroups.

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Detailed Description

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Conditions

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Breast Cancer Overweight Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Less Intensive Group

Participants in this group would receive print materials on diet and exercise and two individual counseling sessions; one at the beginning of the study and another 6 months later.

Group Type ACTIVE_COMPARATOR

Less Intensive

Intervention Type BEHAVIORAL

Participants in this group would receive print materials on diet and exercise and two individual counseling sessions; one at the beginning of the study and another 6 months later.

Intensive Group

Participants in this group would receive print materials on diet and exercise and attend group sessions that would meet weekly for the first 4 months, then every two weeks for the next 2 months, and then monthly for the next 6 months over the course of one year.

Group Type EXPERIMENTAL

Intensive Group

Intervention Type BEHAVIORAL

Participants in this group would receive print materials on diet and exercise and attend group sessions that would meet weekly for the first 4 months, then every two weeks for the next 2 months, and then monthly for the next 6 months over the course of one year.

Interventions

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Less Intensive

Participants in this group would receive print materials on diet and exercise and two individual counseling sessions; one at the beginning of the study and another 6 months later.

Intervention Type BEHAVIORAL

Intensive Group

Participants in this group would receive print materials on diet and exercise and attend group sessions that would meet weekly for the first 4 months, then every two weeks for the next 2 months, and then monthly for the next 6 months over the course of one year.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of breast cancer (stages I (≥1 cm), stage II, or stage IIIA, B, C excluding distant metastasis) diagnosed between 6 months and 5 years earlier; after initial therapies are completed, diagnosed between six months and five years earlier
* BMI between 25 to 45 kg/m2
* Able to comply with all required study procedures and schedule

Exclusion Criteria

* Serious medical condition or psychiatric illness
* Inability to be moderately physically active
* Obesity of known endocrine origin (e.g., untreated hypothyroidism, PCOS)
* Currently enrolled in a weight loss program
* Current use of weight loss medication or supplements
* Previous surgical procedures for weight reduction
* Planning weight loss surgery in the next 2 years.
* 6+ months use of meds likely to cause weight gain or prevent weight loss
* Planned surgical procedure that can impact the conduct of the study
* Currently pregnant/breastfeeding
* Planning to become pregnant within the next 2 years
* Have plans to relocate from area within 2 years
* Family relative or close friend is a trial staff member or a study participant
* Any condition which in the opinion of the investigator makes the subject unsuitable for inclusion in this study

Minimum Eligible Age

21 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes