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

W

Wythenshawe Hospital

Status

Completed

Conditions

Breast Cancer
Weight Changes

Treatments

Behavioral: behavioral dietary intervention
Other: questionnaire administration
Procedure: quality-of-life assessment
Procedure: support group therapy
Behavioral: exercise intervention
Other: educational intervention
Other: laboratory biomarker analysis
Other: counseling intervention

Study type

Observational

Funder types

Other

Identifiers

NCT00869466
NCGPC-B-AHEAD
CDR0000633348 (Registry Identifier)
EU-20906

Details and patient eligibility

About

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.

Full 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.

Enrollment

409 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of early breast cancer

    • Stage I-III disease
    • Invasive or in situ disease
  • No metastatic or inoperable disease

  • Underwent primary surgery for primary breast cancer at UHSM, North Manchester, Royal Oldham, Stepping Hill, Hope Macclesfield General, Tameside General, Leighton Hospitals, or Rochdale Infirmary within the past 10 weeks

  • Receiving/due to start adjuvant chemotherapy, radiotherapy, endocrine therapy, or no adjuvant treatment

  • Hormonal receptor status not specified

PATIENT CHARACTERISTICS:

  • Pre or postmenopausal status

  • Any weight allowed

  • Resident within Greater Manchester or Cheshire area

  • No physical/psychiatric condition that impairs compliance or mobility as assessed from medical history or baseline fitness assessment, including any of the following:

    • Insulin-requiring diabetes (non-insulin requiring diabetics are eligible)
    • 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

Trial contacts and locations

5

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Data sourced from clinicaltrials.gov

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