Ignite Creation Date:
2025-12-24 @ 4:31 PM
Ignite Modification Date:
2025-12-25 @ 6:02 PM
Study NCT ID:
NCT00869466
Status:
COMPLETED
Last Update Posted:
2013-04-04
First Post:
2009-03-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Weight Control Programs in Women Who Have Undergone Surgery for Early Stage Breast Cancer
Sponsor:
Wythenshawe Hospital
Organization:
Study Overview
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.
Status:
COMPLETED
Status Verified Date:
2009-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: