Weight Control Programs in Women Who Have Undergone Surgery for Early Stage Breast Cancer

NCT ID: NCT00869466

Last Updated: 2013-04-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 409 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-08-31
• Study Completion Date: 2011-02-28

Brief Summary

RATIONALE: Measuring changes in body weight and body composition in women with early-stage breast cancer may help doctors plan the best weight control program and improve patients' quality of life. It is not yet known which program is most effective in women with breast cancer.

PURPOSE: This randomized clinical trial is comparing three weight control programs to see how well they work in women who have undergone surgery for early stage breast cancer.

Detailed Description

OBJECTIVES:

Primary

• To assess changes in body weight and composition (i.e., body fat, fat-free mass, dual energy x-ray absorptiometry, bioelectrical impedance, and waist and hip circumference) in patients with early stage breast cancer.

Secondary

• To assess uptake and retention to the interventions and adverse effects of the interventions in these patients.

OUTLINE: This is a multicenter study.

Patients are stratified according to adjuvant treatment (chemotherapy vs no chemotherapy), body mass index (> 27kg/m² vs < 27 kg/m²), treating hospital (UHSM vs North Manchester vs Royal Oldham vs Stepping Hill Hospital), high vs low risk of reducing bone density (i.e., patients receiving aromatase inhibitors vs premenopausal women receiving chemotherapy and/or tamoxifen vs postmenopausal women receiving tamoxifen), and high vs low risk of developing lymphedema (i.e., axillary node clearance vs no axillary node clearance). Patients are randomized to 1 of 3 interventions.

• Arm I: Patients receive standard written advice "Healthy Living With Breast Cancer" booklet from South Manchester University Hospital.
• Arm II: Patients receive individualized diet and exercise advice from a study dietitian for 40 minutes and from the exercise referral officer for 40 minutes. Advice is reinforced with 20-minute bi-weekly phone calls checking compliance, changes in diet, physical activity, individual problems and goals, and recommendations. Patients also receive mailed information summarizing key motivational, behavioral, diet, and exercise issues; information covered in group sessions on weight management; and a booklet providing a program of walking, strengthening, toning, and flexibility exercises.
• Arm III: Patients undergo a supervised group community weight control intervention based on Courneya's exercise prescription guidelines for breast cancer patients and survivors. The intervention consists of a 5-minute warm-up comprising walking and movement to music, 20-30 minutes of circuit training with approximately 10 stations incorporating aerobic activities (i.e., brisk walking, cycling, low-level exercise to music) and muscle strengthening activities (i.e., wall press-up, side leg raises, light weights, and resistance bands), 10-minute cool-down with stretch and flexibility exercises, and 5-minute relaxation period. Patients also undergo a 30-minute diet and behavior change educational session based on the trans theoretical model of behavior changes. The intervention repeats once weekly for 12 weeks. Patients receive a booklet providing a program of walking, strengthening, toning, and flexibility exercises. Patients also receive booster phone calls to reinforce advice, problem solve, and monitor compliance at 4, 6, and 9 months.

In all arms, quality of life is assessed at baseline and 3, 6, and 12 months. Serum bone markers, insulin, glucose, and cardiovascular disease markers are measured periodically.

Conditions

Breast Cancer; Weight Changes

Interventions

behavioral dietary intervention

Intervention Type: BEHAVIORAL

exercise intervention

Intervention Type: BEHAVIORAL

counseling intervention

Intervention Type: OTHER

educational intervention

Intervention Type: OTHER

laboratory biomarker analysis

Intervention Type: OTHER

questionnaire administration

Intervention Type: OTHER

quality-of-life assessment

Intervention Type: PROCEDURE

support group therapy

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Serious digestive and/or absorptive problems, including inflammatory bowel disease
• Cardiovascular or respiratory disease
• Musculoskeletal disease or joint problems
• Psychiatric disorders or conditions (e.g., untreated major depression, psychosis, substance abuse, or severe personality disorder)
• Not considering reconstructive surgery in the next 12 months

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• No concurrent daily medication known to affect body composition (e.g., corticosteroids)

• Patients receiving 2-3 days of steroids with chemotherapy are eligible
• No prior neoadjuvant chemotherapy or endocrine therapy

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Wythenshawe Hospital

OTHER

Sponsor Role: lead

Principal Investigators

Michelle Harvie, MD

Role: PRINCIPAL_INVESTIGATOR

Wythenshawe Hospital

Locations

Wellcome Trust Clinical Research Facility

Manchester, England, United Kingdom

Christie Hospital

Manchester, England, United Kingdom

Nightingale Centre and Genesis Prevention Centre at Wythenshawe Hospital

Manchester, England, United Kingdom

South Manchester University Hospital

Manchester, England, United Kingdom

Cancer Care Research Centre at University of Stirling

Stirling, England, United Kingdom

Countries

United Kingdom

Other Identifiers

CDR0000633348

Identifier Type: REGISTRY

Identifier Source: secondary_id

EU-20906

Identifier Type: -

Identifier Source: secondary_id

NCGPC-B-AHEAD

Identifier Type: -

Identifier Source: org_study_id