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

NCT00869466 | Completed

• 3 other identifiers: NCGPC-B-AHEADCDR0000633348EU-20906
• Study Type: observational
• Target: 409
• Locations: 1 country
• Sites: 5

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.

Conditions

Breast Cancer; Weight Changes

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (14)

• Uptake and retention of information about the interventions and adverse effects of the interventions

• Changes in quality of life as assessed by FACT-B, B-ES, and -F at baseline and at 6 and 12 months

• Changes in markers of breast cancer prognosis at baseline and at 6 and 12 months

• Changes in insulin resistance and glucose homeostasis model assessment (HOMA) at baseline and at 6 and 12 months

• 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

Interventions

behavioral dietary intervention BEHAVIORAL

exercise intervention BEHAVIORAL

counseling intervention OTHER

educational intervention OTHER

laboratory biomarker analysis OTHER

questionnaire administration OTHER

quality-of-life assessment PROCEDURE

support group therapy PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Wythenshawe Hospital: lead

Study Sites (5)

Wellcome Trust Clinical Research Facility

Manchester, England, M13 9WL, United Kingdom

Location

Christie Hospital

Manchester, England, M20 4BX, United Kingdom

Location

Nightingale Centre and Genesis Prevention Centre at Wythenshawe Hospital

Manchester, England, M23 9LT, United Kingdom

Location

South Manchester University Hospital

Manchester, England, M23 9LT, United Kingdom

Location

Cancer Care Research Centre at University of Stirling

Stirling, England, FK9 4NF, United Kingdom

Location

MeSH Terms

Conditions

Breast Neoplasms; Body Weight Changes

Interventions

Counseling; Early Intervention, Educational

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Child Health Services; Preventive Health Services

Study Officials

• Michelle Harvie, MD

  Wythenshawe Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 25, 2009
• First Posted: March 26, 2009
• Study Start: August 1, 2008
• Study Completion: February 1, 2011
• Last Updated: April 4, 2013

Record last verified: 2009-03

Locations

GB (5)