Breast CancerNCT00336089
Exercise Program or Health Education Program in Reducing Fatigue and Pain in Breast Cancer Survivors
A study testing exercise intervention, educational intervention and complementary or alternative medicine procedure in people with Breast Cancer and Cancer Survivor, run by Clayton State University at 2 sites in United States.
Trial summary
RATIONALE: An exercise program or health education program may help relieve fatigue and pain and improve the quality of life in women who are breast cancer survivors. It is not yet known whether an exercise program is more effective than a health education program or no program in reducing fatigue and pain in women… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Breast Cancer, Cancer Survivor, Fatigue
- What is being tested?
- exercise intervention, educational intervention and complementary or alternative medicine procedure
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- How many people
- 54 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2006to Dec 2008
- Phase
- Interventional
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
DISEASE CHARACTERISTICS:
- Breast cancer survivor
- Received adjuvant chemotherapy or radiotherapy for breast cancer only
- Must have completed treatment 2-6 months ago
- Hormone receptor status not specified
PATIENT CHARACTERISTICS:
- Female
- Menopausal status not specified
- Hemoglobin ≥ 11 g/dL
- Able to read English
- No high-risk for cardiovascular problems during exercise, including any of the following:
- Unstable heart disease
- Unstable angina
- Chronic respiratory disease
- Dizziness
- Uncontrolled hypertension
- No severe respiratory disease requiring oxygen therapy
- No history of anorexia (body mass index [BMI] < 18.5) or severe obesity (BMI > 35)
- No history of multiple cancers
- No shortness of breath or hypotension
- No sudden swelling of the ankles, hands or face
- No palpitations or arrhythmias
- No persistent and intolerable pain
- No major acute illness (e.g., fever or respiratory infection)
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Saint Joseph's Hospital of Atlanta
Atlanta, Georgia, 30342-1701
Clinical Trials Office - Saint Joseph's Hospital of Atlanta, 404-851-7115
- Recruiting
Clayton State University
Morrow, Georgia, 30260-0285
Melanie Poudevigne, PhD, 678-466-4937, mpoudevigne@clayton.edu
About this study
Official title: The Effects of Cross Training on Fatigue and Pain Levels in Breast Cancer Survivors
RATIONALE: An exercise program or health education program may help relieve fatigue and pain and improve the quality of life in women who are breast cancer survivors. It is not yet known whether an exercise program is more effective than a health education program or no program in reducing fatigue and pain in women who are breast cancer survivors.
PURPOSE: This randomized clinical trial is studying an exercise program to see how well it works in reducing fatigue and pain compared to a health education program or no program in women who are breast cancer survivors.
Read the detailed description
OBJECTIVES:
- Determine whether a moderate-intensity exercise program comprising cardiorespiratory and resistance training of the legs, back, abdominal, trunk, and arm musculature vs a control group attenuates fatigue and pain in breast cancer survivors.
- Determine whether this exercise program will significantly improve the quality of life of these patients.
- Determine whether this exercise program can significantly reduce the number of days of absenteeism from work in these patients.
- Determine whether this exercise program can significantly attenuate mood disturbances in these patients.
OUTLINE: This is a randomized, controlled, pilot study. Patients are randomized to 1 of 2 treatment arms.
- Arm I (exercise program): Patients participate in an exercise program comprising cardiorespiratory (walking on a treadmill) and resistance training for 1 hour, 3 times weekly for 12 weeks.
- Arm II (control): Patients undergo no intervention. In both arms, patients complete questionnaires regarding general health, mood, work attendance, and physical activity before the start of study treatment and then every 3 weeks for 12 weeks. Patients also complete a 7-day physical activity diary and sleep diary every 3 weeks.
PROJECTED ACCRUAL: A total of 54 patients will be accrued for this study.
- Conditions
- Breast Cancer, Cancer Survivor, Fatigue, Pain
- Being tested
- exercise intervention, educational intervention, complementary or alternative medicine procedure, fatigue assessment and management, management of therapy complications
- Keywords
- fatigue, pain, cancer survivor, breast cancer in situ, inflammatory breast cancer, stage IA breast cancer, stage IB breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, stage IV breast cancer, recurrent breast cancer
- Medical subject headings
- Breast Neoplasms, Fatigue, Pain, Breast Carcinoma In Situ, Inflammatory Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercise interventionBehavioural
educational interventionOther
complementary or alternative medicine procedureProcedure or surgery
fatigue assessment and managementProcedure or surgery
management of therapy complicationsProcedure or surgery
pain therapyProcedure or surgery
quality-of-life assessmentProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2006 (estimated)
- Study startJan 2006
- Primary completionDec 2008 (estimated)
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
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clayton State University
- Sponsor type
- University, hospital or other
- Investigators
- Melanie Poudevigne, PhD, Study chair, Clayton State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00336089
- Sponsor's protocol ID
- CDR0000466676
- Other IDs
- CSU-GCC-161
- Status last verified
- Jul 2009
- First submitted
- 8 Jun 2006
- Last updated
- 17 Sep 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Cross Training on Fatigue and Pain Levels in Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT00336089
- Acronym / sponsor ID
- CDR0000466676
- Conditions
- Breast Cancer, Cancer Survivor, Fatigue, Pain
- Keywords
- fatigue, pain, cancer survivor, breast cancer in situ, inflammatory breast cancer, stage IA breast cancer, stage IB breast cancer, stage II breast cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Clayton State UniversityUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Dec 2008 (estimated)
- First posted
- 12 Jun 2006 (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: An exercise program or health education program may help relieve fatigue and pain and improve the quality of life in women who are breast cancer survivors. It is not yet known whether an exercise program is more effective than a health education program or no program in reducing fatigue and pain in women who are breast cancer survivors.
PURPOSE: This randomized clinical trial is studying an exercise program to see how well it works in reducing fatigue and pain compared to a health education program or no program in women who are breast cancer survivors.
Detailed description
OBJECTIVES:
- Determine whether a moderate-intensity exercise program comprising cardiorespiratory and resistance training of the legs, back, abdominal, trunk, and arm musculature vs a control group attenuates fatigue and pain in breast cancer survivors.
- Determine whether this exercise program will significantly improve the quality of life of these patients.
- Determine whether this exercise program can significantly reduce the number of days of absenteeism from work in these patients.
- Determine whether this exercise program can significantly attenuate mood disturbances in these patients.
OUTLINE: This is a randomized, controlled, pilot study. Patients are randomized to 1 of 2 treatment arms.
- Arm I (exercise program): Patients participate in an exercise program comprising cardiorespiratory (walking on a treadmill) and resistance training for 1 hour, 3 times weekly for 12 weeks.
- Arm II (control): Patients undergo no intervention. In both arms, patients complete questionnaires regarding general health, mood, work attendance, and physical activity before the start of study treatment and then every 3 weeks for 12 weeks. Patients also complete a 7-day physical activity diary and sleep diary every 3 weeks.
PROJECTED ACCRUAL: A total of 54 patients will be accrued for this study.
Study design
- Allocation
- Randomised
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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 |
|---|---|---|
| exercise intervention | Behavioural | – |
| educational intervention | Other | – |
| complementary or alternative medicine procedure | Procedure or surgery | – |
| fatigue assessment and management | Procedure or surgery | – |
| management of therapy complications | Procedure or surgery | – |
| pain therapy | Procedure or surgery | – |
| quality-of-life assessment | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 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.
Melanie Poudevigne, PhD study chair
Clayton State University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise intervention, educational intervention and complementary or alternative medicine procedure in people with Breast Cancer and Cancer Survivor, run by Clayton State University at 2 sites in United States.
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: status not confirmed, as of the sponsor's last update on 17 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
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 17 Sep 2013.