Breast CancerNCT00379106
Arm Function and Quality of Life Following Mastectomy.
A study testing Arm exercises. and Arm Exercises in people with Breast Cancer, run by University of New Mexico at 1 site in United States.
Trial summary
To measure arm function and quality of life of mastectomy patients. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Arm exercises. and Arm Exercises
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2003to Sep 2007
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients who have been referred from UNMH to CRTC for further treatment following mastectomy/lumpectomy surgery.
Who cannot join
- Not specified
Trial locations and contacts
1 site in 1 country.
United States1 site
University of New Mexico
Albuquerque, New Mexico, 87130
About this study
To measure arm function and quality of life of mastectomy patients.
Read the detailed description
Treatment: Randomized to one of two treatment arms. Group One: Basic active exercise program at home. Group Two: Instruction in the same active exercise program along with additional exercises using exercise equipment and stretching exercises. Range of Motion measurements will be taken at the first session, 1 month, 6 weeks, 3 months, 6 months and 1 year. Patients will complete demographic form, functional questionnaire, and QOL questionnaire.
- Conditions
- Breast Cancer
- Being tested
- Arm exercises., Arm Exercises
- Keywords
- Supportive, Mastectomy, Quality of Life, Arm Function
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arm exercises.Procedure or surgery
Basic active exercise program at home.
Arm ExercisesProcedure or surgery
Instruction in the same active exercise program along with additional exercises using exercise equipment and stretching exercises
| Study group | Role | What they receive |
|---|---|---|
| Group1 | Active comparator | Not described Receives: Procedure: Arm exercises. |
| Group 2 | Experimental | Not described Receives: Procedure: Arm Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arm Function and Quality of Life Following Mastectomy
Measured: Motion measurements will be taken at the first session, 1 month, 6 weeks, 3 months, 6 months and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2006 (estimated)
- Study startOct 2003
- Primary completionDec 2005
- Study completionSep 2007
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Investigators
- Kathy Dieruf, Principal investigator, University of New Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00379106
- Sponsor's protocol ID
- 1002C
- Status last verified
- Mar 2008
- First submitted
- 19 Sep 2006
- Last updated
- 7 Jan 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arm Function and Quality of Life Following Mastectomy.
- ClinicalTrials.gov ID
- NCT00379106
- Acronym / sponsor ID
- 1002C
- Conditions
- Breast Cancer
- Keywords
- Supportive, Mastectomy, Quality of Life, Arm Function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Study start
- Oct 2003
- Primary completion
- Dec 2005 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 21 Sep 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.
To measure arm function and quality of life of mastectomy patients.
Detailed description
Treatment: Randomized to one of two treatment arms. Group One: Basic active exercise program at home. Group Two: Instruction in the same active exercise program along with additional exercises using exercise equipment and stretching exercises. Range of Motion measurements will be taken at the first session, 1 month, 6 weeks, 3 months, 6 months and 1 year. Patients will complete demographic form, functional questionnaire, and QOL questionnaire.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group1 | Active comparator | Procedure: Arm exercises. |
| Group 2 | Experimental | Procedure: Arm Exercises |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who have been referred from UNMH to CRTC for further treatment following mastectomy/lumpectomy surgery.
Key exclusion criteria (1 listed)
- Not specified
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 |
|---|---|---|
| Arm exercises.Basic active exercise program at home. | Procedure or surgery | Group1 |
| Arm ExercisesInstruction in the same active exercise program along with additional exercises using exercise equipment and stretching exercises | Procedure or surgery | Group 2 |
Primary outcome
Arm Function and Quality of Life Following Mastectomy
Time frame: Motion measurements will be taken at the first session, 1 month, 6 weeks, 3 months, 6 months and 1 year
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 7 Jan 2010.
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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.
Kathy Dieruf principal investigator
University of New Mexico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arm exercises. and Arm Exercises in people with Breast Cancer, run by University of New Mexico 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 1 inclusion and 1 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 7 Jan 2010. 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?
Arm Function and Quality of Life Following Mastectomy (time frame: Motion measurements will be taken at the first session, 1 month, 6 weeks, 3 months, 6 months and 1 year). 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 7 Jan 2010.