Breast CancerNCT00869466
Weight Control Programs in Women Who Have Undergone Surgery for Early Stage Breast Cancer
An observational study of Breast Cancer and Weight Changes, run by Wythenshawe Hospital at 5 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Weight Changes
- What is being tested?
- behavioral dietary intervention, exercise intervention and counseling intervention
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- How many people
- 409 participants
- Where
- 5 sitesUnited Kingdom
- Study dates
- Aug 2008to Feb 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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 locations and contacts
5 sites in 1 country.
5 sites in 1 country
United Kingdom5 sites
Wellcome Trust Clinical Research Facility
Manchester, England, M13 9WL
Christie Hospital
Manchester, England, M20 4BX
Nightingale Centre and Genesis Prevention Centre at Wythenshawe Hospital
Manchester, England, M23 9LT
South Manchester University Hospital
Manchester, England, M23 9LT
Cancer Care Research Centre at University of Stirling
Stirling, England, FK9 4NF
About this study
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.
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.
Read the 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
- Being tested
- behavioral dietary intervention, exercise intervention, counseling intervention, educational intervention, laboratory biomarker analysis
- 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
- Medical subject headings
- Breast Neoplasms, Body Weight Changes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
behavioral dietary interventionBehavioural
exercise interventionBehavioural
counseling interventionOther
educational interventionOther
laboratory biomarker analysisOther
questionnaire administrationOther
quality-of-life assessmentProcedure or surgery
support group therapyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Changes in fitness as assessed by a 12-minute walk test at baseline and at 6 and 12 months
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
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
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
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
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
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
Patient experience of interventions through in-depth focus group discussions and individual interviews
Factors predicting adherence to interventions with scales of stage of behavior change for weight control and exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2009 (estimated)
- Study startAug 2008
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 409 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wythenshawe Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Michelle Harvie, MD, Principal investigator, Wythenshawe Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00869466
- Sponsor's protocol ID
- NCGPC-B-AHEAD
- Other IDs
- CDR0000633348, EU-20906
- Status last verified
- Mar 2009
- First submitted
- 25 Mar 2009
- Last updated
- 4 Apr 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00869466
- Acronym / sponsor ID
- NCGPC-B-AHEAD
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 409 participants (actual)
- Lead sponsor
- Wythenshawe HospitalUniversity, hospital or other
- Study start
- Aug 2008
- Study completion
- Feb 2011 (actual)
- First posted
- 26 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| behavioral dietary intervention | Behavioural | – |
| exercise intervention | Behavioural | – |
| counseling intervention | Other | – |
| educational intervention | Other | – |
| laboratory biomarker analysis | Other | – |
| questionnaire administration | Other | – |
| quality-of-life assessment | Procedure or surgery | – |
| support group therapy | Procedure or surgery | – |
Primary outcome
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
14 secondary outcomes
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
Changes in fitness as assessed by a 12-minute walk test at baseline and at 6 and 12 months
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
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
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
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
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
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
Patient experience of interventions through in-depth focus group discussions and individual interviews
Factors predicting adherence to interventions with scales of stage of behavior change for weight control and exercise
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michelle Harvie, MD principal investigator
Wythenshawe Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Weight Changes, run by Wythenshawe Hospital at 5 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2013.