Breast CancerNCT00489125
Strength and Range of Motion in Women Undergoing Surgery for Breast Cancer
An observational study of Breast Cancer, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
RATIONALE: Gathering information about strength and range of motion over time from women undergoing surgery for breast cancer may help doctors learn more about recovery from surgery and on-going care. Read more about this study
- Who is it for?
- Ages Up to 120 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- physiologic testing
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2004to 20 Jul 2018
- 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 Up to 120 years
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Any woman treated in the Breast Clinic of WFUBMC with a diagnosis of stage 0-IV breast cancer and identified as a candidate by their surgeon.
Who may be able to join
- Diagnosis of breast cancer
- Stage I-IV disease
- Planning to undergo surgery at the Comprehensive Cancer Center Breast Clinic at Wake Forest University Baptist Medical Center
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157-1096
About this study
Official title: Breast Clinic Strength and Range of Motion Study
RATIONALE: Gathering information about strength and range of motion over time from women undergoing surgery for breast cancer may help doctors learn more about recovery from surgery and on-going care.
PURPOSE: This clinical trial is collecting information about strength and range of motion over time from women undergoing surgery for breast cancer.
Read the detailed description
OBJECTIVES:
- Collect data regarding diagnosis, type of surgery, receipt of adjuvant therapy, age, height, weight, waist circumference, arm strength, grip strength, shoulder range of motion, and physical activity participation from women undergoing surgery for breast cancer.
- Examine changes in physical activity participation, measures of body composition, shoulder range of motion, grip strength, and arm strength over time in these patients.
- Determine differences in changes in physical activity and indices of fitness according to type of surgery and adjuvant therapy.
- Examine relationships between exercise participation, fitness, and body composition over time.
- Correlate data with an ongoing randomized exercise trial that includes strength and flexibility assessments with no pre-surgery measures.
OUTLINE: This is a prospective, cohort study.
Patients submit data comprising demographic/medical information, anthropometrics (weight, height, waist circumference), grip strength, bicep strength, shoulder range of motion, and physical activity participation prior to surgery, at each surgical follow-up visit, and at 2 years after surgery.
- Conditions
- Breast Cancer
- Being tested
- physiologic testing
- Keywords
- long-term effects secondary to cancer therapy in adults, recurrent breast cancer, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, stage IV breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physiologic testingOther
physical testing of range of motion, grip strength etc.
What is being measured
The primary outcome is the main question the study is designed to answer.
Collection of data before surgery, at each follow-up visit, and at 2 years after surgery
Measured: approximately 2 years
Changes in physical activity participation, measures of body composition, shoulder range of motion, grip strength, and arm strength over time
Measured: approximately 2 years
Differences in changes in physical activity and indices of fitness according to type of surgery and adjuvant therapy
Measured: approximately 2 years
Relationships between exercise participation, fitness, and body composition over time
Measured: approximately 2 years
Correlation of data with an ongoing randomized exercise trial that includes strength and flexibility assessments with no pre-surgery measures
Measured: approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2007 (estimated)
- Study start15 Oct 2004
- Primary completion20 Jul 2018
- Study completion20 Jul 2018
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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Shannon Mihalko, PhD, Principal investigator, Wake Forest University Health SciencesEdward A. Levine, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00489125
- Sponsor's protocol ID
- CCCWFU 97305
- Other IDs
- P30CA012197, CCCWFU-97305, CCCWFU-BG05-106
- Status last verified
- May 2019
- First submitted
- 20 Jun 2007
- Last updated
- 4 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breast Clinic Strength and Range of Motion Study
- ClinicalTrials.gov ID
- NCT00489125
- Acronym / sponsor ID
- CCCWFU 97305
- Conditions
- Breast Cancer
- Keywords
- long-term effects secondary to cancer therapy in adults, recurrent breast cancer, 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
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 15 Oct 2004 (actual)
- Primary completion
- 20 Jul 2018 (actual)
- Study completion
- 20 Jul 2018 (actual)
- First posted
- 21 Jun 2007 (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: Gathering information about strength and range of motion over time from women undergoing surgery for breast cancer may help doctors learn more about recovery from surgery and on-going care.
PURPOSE: This clinical trial is collecting information about strength and range of motion over time from women undergoing surgery for breast cancer.
Detailed description
OBJECTIVES:
- Collect data regarding diagnosis, type of surgery, receipt of adjuvant therapy, age, height, weight, waist circumference, arm strength, grip strength, shoulder range of motion, and physical activity participation from women undergoing surgery for breast cancer.
- Examine changes in physical activity participation, measures of body composition, shoulder range of motion, grip strength, and arm strength over time in these patients.
- Determine differences in changes in physical activity and indices of fitness according to type of surgery and adjuvant therapy.
- Examine relationships between exercise participation, fitness, and body composition over time.
- Correlate data with an ongoing randomized exercise trial that includes strength and flexibility assessments with no pre-surgery measures.
OUTLINE: This is a prospective, cohort study.
Patients submit data comprising demographic/medical information, anthropometrics (weight, height, waist circumference), grip strength, bicep strength, shoulder range of motion, and physical activity participation prior to surgery, at each surgical follow-up visit, and at 2 years after surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 120 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Any woman treated in the Breast Clinic of WFUBMC with a diagnosis of stage 0-IV breast cancer and identified as a candidate by their surgeon.
Key inclusion criteria (3 listed)
- Diagnosis of breast cancer
- Planning to undergo surgery at the Comprehensive Cancer Center Breast Clinic at Wake Forest University Baptist Medical Center
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| physiologic testingphysical testing of range of motion, grip strength etc. | Other | – |
Primary outcome
Collection of data before surgery, at each follow-up visit, and at 2 years after surgery
Time frame: approximately 2 years
Changes in physical activity participation, measures of body composition, shoulder range of motion, grip strength, and arm strength over time
Time frame: approximately 2 years
Differences in changes in physical activity and indices of fitness according to type of surgery and adjuvant therapy
Time frame: approximately 2 years
Relationships between exercise participation, fitness, and body composition over time
Time frame: approximately 2 years
Correlation of data with an ongoing randomized exercise trial that includes strength and flexibility assessments with no pre-surgery measures
Time frame: approximately 2 years
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 Jun 2019.
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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.
Shannon Mihalko, PhD principal investigator
Wake Forest University Health Sciences
Edward A. Levine, MD 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?
An observational study of 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 3 inclusion and 0 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 4 Jun 2019. 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?
Collection of data before surgery, at each follow-up visit, and at 2 years after surgery (time frame: approximately 2 years). The study lists 5 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 4 Jun 2019.