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

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00869466
First received: March 25, 2009
Last updated: April 2, 2013
Last verified: March 2009
  Purpose

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.


Condition Intervention
Breast Cancer
Weight Changes
Behavioral: behavioral dietary intervention
Behavioral: exercise intervention
Other: counseling intervention
Other: educational intervention
Other: laboratory biomarker analysis
Other: questionnaire administration
Procedure: quality-of-life assessment
Procedure: support group therapy

Study Type: Observational
Official Title: B- AHEAD Study (Breast - Activity & Healthy Eating After Diagnosis) Randomised Comparison of 3 Weight Control Programmes During Adjuvant Treatment for Early Breast Cancer.

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 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) at baseline and at 6 and 12 months [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Uptake and retention of information about the interventions and adverse effects of the interventions [ Designated as safety issue: No ]
  • Changes in quality of life as assessed by FACT-B, B-ES, and -F at baseline and at 6 and 12 months [ Designated as safety issue: No ]
  • Changes in markers of breast cancer prognosis at baseline and at 6 and 12 months [ Designated as safety issue: No ]
  • Changes in insulin resistance and glucose homeostasis model assessment (HOMA) at baseline and at 6 and 12 months [ Designated as safety issue: No ]
  • Cardiovascular disease-risk markers (i.e., total LDL and HDL cholesterol, triglycerides, and systolic/diastolic blood pressure) at baseline and at 6 and 12 months [ Designated as safety issue: No ]
  • Changes in fitness as assessed by a 12-minute walk test at baseline and at 6 and 12 months [ Designated as safety issue: No ]
  • Changes in arm mobility, function (as assessed by quick DASH), and pain (as assessed by pain rating scale and S-LANSS for neuropathic pain) at baseline and at 6 and 12 months [ Designated as safety issue: No ]
  • Changes in dietary intake (as assessed by a 7-day food diary) and activity (as assessed by a 7-day activity diary) as measures of compliance at baseline and at 6 and 12 months [ Designated as safety issue: No ]
  • Changes in serum bone markers/bone specific alkaline phosphatase for bone formation and the cross linked C-telopeptides of type I collagen for bone resorption at baseline and at 6 and 12 months [ Designated as safety issue: No ]
  • Changes in ipsilateral arm circumference (compared to contralateral arm) using perometer in patients having axillary node clearance at baseline and at 6 and 12 months [ Designated as safety issue: No ]
  • Changes in generic health status and quality of life (as assessed by EQ-5D utility measure) and health resource usage to assess the relative cost effectiveness of the interventions at baseline and at 3, 6, and 12 months [ Designated as safety issue: No ]
  • Changes in isometric and isokinetic muscle strength of quadriceps in patients receiving aromatase inhibitors and age-matched patients receiving tamoxifen in a subset of patients in the standard written only group [ Designated as safety issue: No ]
  • Patient experience of interventions through in-depth focus group discussions and individual interviews [ Designated as safety issue: No ]
  • Factors predicting adherence to interventions with scales of stage of behavior change for weight control and exercise [ Designated as safety issue: No ]

Enrollment: 409
Study Start Date: August 2008
Study Completion Date: February 2011
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  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: NCT00869466

Locations
United Kingdom
Christie Hospital
Manchester, England, United Kingdom, M20 4BX
Nightingale Centre and Genesis Prevention Centre at Wythenshawe Hospital
Manchester, England, United Kingdom, M23 9LT
South Manchester University Hospital
Manchester, England, United Kingdom, M23 9LT
Wellcome Trust Clinical Research Facility
Manchester, England, United Kingdom, M13 9WL
Cancer Care Research Centre at University of Stirling
Stirling, England, United Kingdom, FK9 4NF
Sponsors and Collaborators
Wythenshawe Hospital
Investigators
Principal Investigator: Michelle Harvie, MD Wythenshawe Hospital
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00869466     History of Changes
Other Study ID Numbers: NCGPC-B-AHEAD, CDR0000633348, EU-20906
Study First Received: March 25, 2009
Last Updated: April 2, 2013
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
weight changes
stage IA breast cancer
stage IB breast cancer
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer

Additional relevant MeSH terms:
Body Weight Changes
Breast Neoplasms
Body Weight
Signs and Symptoms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on July 29, 2014