Stage I Breast CancerNCT01113554
Breast Cancer Rehabilitation Program in Improving Quality of Life in Breast Cancer Survivors
A study testing questionnaire administration, exercise intervention and quality-of-life assessment in people with Stage I Breast Cancer and Stage II Breast Cancer, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
RATIONALE: A breast cancer rehabilitation program and exercise therapy may help improve the quality of life of breast cancer survivors. PURPOSE: This clinical trial studies a breast cancer rehabilitation program in improving quality of life in breast cancer survivors. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Stage I Breast Cancer, Stage II Breast Cancer, Stage IIIA Breast Cancer
- What is being tested?
- questionnaire administration, exercise intervention and quality-of-life assessment
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2010to Nov 2012
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- First occurrence of breast cancer
- BMI >= 25
- Recently completed treatment(chemotherapy/radiation) for breast cancer (=< 8 weeks), but can be receiving adjuvant hormonal therapy
- Willing to comply with study visits, as outlined in the protocol
- Lives within 30 miles of study site, or willing to travel to study site if outside a 30-mile radius
- Ability to participate in a moderate exercise program, such as freedom from any orthopedic abnormalities that would prevent participation
- Ability to understand and the willingness to sign a written informed consent document
Who cannot join
- Unstable angina
- Cardiac conduction disturbances
- Plans to move from the study area
- Dementia that is medically documented or suspected
- Advanced arterial disease causing ischemia of any limb
- Physical immobility
Show all 10Show fewer
- Homebound for medical reasons
- Dependent on wheelchair for mobility
- Chronic disease which significantly reduces 4-year survival
- Recurrent breast cancer
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: A Pilot Study to Evaluate the Feasibility of a Breast Cancer Rehabilitation Program in Survivors of Breast Cancer
RATIONALE: A breast cancer rehabilitation program and exercise therapy may help improve the quality of life of breast cancer survivors.
PURPOSE: This clinical trial studies a breast cancer rehabilitation program in improving quality of life in breast cancer survivors.
Read the detailed description
PRIMARY OBJECTIVES:
- To estimate accrual, retention, adherence, and participation of breast cancer survivors to a breast cancer rehabilitation program.
II. To estimate the variability of weight, six-minute walk, quality of life and other psychosocial and physical measures in women participating in the BCRP.
SECONDARY OBJECTIVES:
- To assess changes in the anthropometric, psychosocial, and physical outcomes over the six-month period of the BCRP.
II. To document the types and the rates of adverse events associated with the BCRP.
OUTLINE:
Patients attend exercise therapy sessions over 1 hour 3 times a week for 6 months. Exercise therapy sessions are comprised of a 10 minute warm-up of light stretching and aerobic type exercise (walking, cycling), 30 minutes of endurance type exercise (cycle, walking), and 20 minutes of resistance training exercise.
- Conditions
- Stage I Breast Cancer, Stage II Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer, Stage IV Breast Cancer
- Being tested
- questionnaire administration, exercise intervention, quality-of-life assessment, survey administration, management of therapy complications
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaire administrationOther
exercise interventionBehavioural
quality-of-life assessmentProcedure or surgery
Also called quality of life assessment
survey administrationOther
management of therapy complicationsProcedure or surgery
Also called complications of therapy, management of
psychosocial assessment and careProcedure or surgery
Also called psychosocial assessment, psychosocial assessment/care, psychosocial care, psychosocial care/assessment
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Experimental | Patients attend exercise therapy sessions over 1 hour 3 times a week for 6 months. Exercise therapy sessions are comprised of a 10 minute warm-up of light stretching and aerobic type exercise (walking, cycling), 30 minutes of endurance type exercise (cycle, walking), and 20 minutes of resistance training exercise. Receives: Other: questionnaire administration; Behavioral: exercise intervention; Procedure: quality-of-life assessment; Other: survey administration; Procedure: management of therapy complications; Procedure: psychosocial assessment and care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ability to recruit breast cancer survivors into a six-month breast cancer rehabilitation program
Measured: Approximately 24 months
BMI
Measured: 6 months
Muscular strength
Measured: 6 months
Range of motion
Measured: 6 months
Quality of life
Measured: 6 months
Proportion of screened women who are eligible for the study and the proportion of eligible women who agree to participate
Measured: Approximately 24 months
Proportion of women who complete the study and the average number of weeks of participation
Measured: Approximately 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2010 (estimated)
- Study startJun 2010
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage I Breast CancerStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mara Vitolins, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01113554
- Sponsor's protocol ID
- IRB00012783
- Other IDs
- NCI-2010-00975, CCCWFU 99309
- Status last verified
- Jul 2018
- First submitted
- 28 Apr 2010
- Last updated
- 5 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Evaluate the Feasibility of a Breast Cancer Rehabilitation Program in Survivors of Breast Cancer
- ClinicalTrials.gov ID
- NCT01113554
- Acronym / sponsor ID
- IRB00012783
- Conditions
- Stage I Breast Cancer, Stage II Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer, Stage IV Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 30 Apr 2010 (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: A breast cancer rehabilitation program and exercise therapy may help improve the quality of life of breast cancer survivors.
PURPOSE: This clinical trial studies a breast cancer rehabilitation program in improving quality of life in breast cancer survivors.
Detailed description
PRIMARY OBJECTIVES:
- To estimate accrual, retention, adherence, and participation of breast cancer survivors to a breast cancer rehabilitation program.
II. To estimate the variability of weight, six-minute walk, quality of life and other psychosocial and physical measures in women participating in the BCRP.
SECONDARY OBJECTIVES:
- To assess changes in the anthropometric, psychosocial, and physical outcomes over the six-month period of the BCRP.
II. To document the types and the rates of adverse events associated with the BCRP.
OUTLINE:
Patients attend exercise therapy sessions over 1 hour 3 times a week for 6 months. Exercise therapy sessions are comprised of a 10 minute warm-up of light stretching and aerobic type exercise (walking, cycling), 30 minutes of endurance type exercise (cycle, walking), and 20 minutes of resistance training exercise.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Other: questionnaire administration, Behavioral: exercise intervention, Procedure: quality-of-life assessment, Other: survey administration, Procedure: management of therapy complications, Procedure: psychosocial assessment and carePatients attend exercise therapy sessions over 1 hour 3 times a week for 6 months. Exercise therapy sessions are comprised of a 10 minute warm-up of light stretching and aerobic type exercise (walking, cycling), 30 minutes of endurance type exercise (cycle, walking), and 20 minutes of resistance training exercise. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- First occurrence of breast cancer
- BMI >= 25
- Recently completed treatment(chemotherapy/radiation) for breast cancer (=< 8 weeks), but can be receiving adjuvant hormonal therapy
- Willing to comply with study visits, as outlined in the protocol
- Lives within 30 miles of study site, or willing to travel to study site if outside a 30-mile radius
Key exclusion criteria (10 listed)
- Unstable angina
- Cardiac conduction disturbances
- Plans to move from the study area
- Dementia that is medically documented or suspected
- Advanced arterial disease causing ischemia of any limb
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 |
|---|---|---|
| questionnaire administration | Other | Arm I |
| exercise intervention | Behavioural | Arm I |
| quality-of-life assessmentAlso: quality of life assessment | Procedure or surgery | Arm I |
| survey administration | Other | Arm I |
| management of therapy complicationsAlso: complications of therapy, management of | Procedure or surgery | Arm I |
| psychosocial assessment and careAlso: psychosocial assessment, psychosocial assessment/care, psychosocial care, psychosocial care/assessment | Procedure or surgery | Arm I |
Primary outcome
Ability to recruit breast cancer survivors into a six-month breast cancer rehabilitation program
Time frame: Approximately 24 months
BMI
Time frame: 6 months
Muscular strength
Time frame: 6 months
Range of motion
Time frame: 6 months
Quality of life
Time frame: 6 months
Proportion of screened women who are eligible for the study and the proportion of eligible women who agree to participate
Time frame: Approximately 24 months
Proportion of women who complete the study and the average number of weeks of participation
Time frame: Approximately 24 months
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 5 Jul 2018.
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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.
Mara Vitolins principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing questionnaire administration, exercise intervention and quality-of-life assessment in people with Stage I Breast Cancer and Stage II Breast Cancer, run by Wake Forest University Health Sciences at 1 site 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?
The sponsor lists 7 inclusion and 10 exclusion criteria. 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 5 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
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?
Ability to recruit breast cancer survivors into a six-month breast cancer rehabilitation program (time frame: Approximately 24 months). The study lists 7 primary outcomes in all. 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 5 Jul 2018.