Musculoskeletal ComplicationNCT02370264
Questionnaires in Identifying Upper Extremity Function and Quality of Life After Treatment in Patients With Breast Cancer
A study testing Quality-of-Life Assessment, Questionnaire Administration and Medical Chart Review in people with Musculoskeletal Complication and Recurrent Breast Carcinoma, run by University of Southern California at 1 site in United States.
Trial summary
This pilot clinical trial studies questionnaires in identifying arms, shoulder, and neck (upper extremity) function and quality of life after treatment in patients with breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Musculoskeletal Complication, Recurrent Breast Carcinoma, Stage IA Breast Cancer
- What is being tested?
- Quality-of-Life Assessment, Questionnaire Administration and Medical Chart Review
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2012to 21 Oct 2016
- 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
- All patients with a history of breast cancer surgery either lumpectomy, mastectomy, axillary node dissection or sentinel node biopsy at least one year ago and received either radiation therapy or chemotherapy or both
- Patients with no active disease; (as defined as no detectable disease)
- Patients with stable metastatic disease which is defined as (metastatic tumor demonstrates no increase in volume, tumor size or diameter and no evidence of new lesions, have been identified during last assessment by medical oncologist/radiologist or surgeons)
- Signed informed consent
Who cannot join
- Survivors of breast cancer that have not received either breast surgery or radiation therapy
- Patients with known cognitive impairments
- Individuals with progressive metastatic disease in which the tumor has increased in size, volume and diameter or evidence of new lesions, as noted by medical oncologists, radiologists and surgeons
- individuals who are non-ambulatory
- Women who self-report to be pregnant
- As this is an observational study, we will not be performing a pregnancy test, participants will be asked if they are or are not pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033
About this study
Official title: Screening for Musculoskeletal Impairments and Quality of Life in Individuals Post-Treatment for Breast Cancer
This pilot clinical trial studies questionnaires in identifying arms, shoulder, and neck (upper extremity) function and quality of life after treatment in patients with breast cancer. Patients may experience arms, shoulder, and neck impairments that negatively affect their functioning and quality of life after cancer-related treatment. Studying upper extremity function and quality of life in patients after breast cancer treatment may help doctors determine the prevalence and severity of long-term functional impairments and the relationship between the perception of impairments due to breast cancer treatment and its' impact on quality of life.
Read the detailed description
PRIMARY OBJECTIVES:
- To characterize patients' upper extremity functionality (using the Disabilities of the Arm, Shoulder and Hand [DASH] questionnaire) and their perception of quality of life (using the Functional Assessment of Cancer Therapy-Breast [FACT-B] questionnaire) one to ten years after breast cancer surgery and compare it to the general population.
II. To investigate whether patients' upper extremity functionality and their perception of quality of life after completion of breast cancer treatment changes over the duration of time between 1 -10 years after breast cancer surgery.
III. To characterize patient perception of the impact of breast cancer on their quality of life in relation to current upper-extremity functionality 1-10 years after breast cancer surgery.
IV. To characterize patients' upper extremity functionality (using the DASH questionnaire) and their perception of the impact of breast cancer on their quality of life (using the FACT-B questionnaire) in a sub group of individuals with stable metastatic breast cancer 1-10 years after initial diagnosis and surgery.
SECONDARY OBJECTIVES:
- To assist the multidisciplinary team to identify musculoskeletal barriers (if any) that impact a patient's long-term recovery with respect to the breast cancer treatments they have received.
II. To assist in developing and implementing a physical therapy component within the Personalized Medicine to Breast Cancer Care Plan; this includes early detection of potential physical barriers, physical therapy intervention models, and development of survivorship planning for cancer-related musculoskeletal impairments.
OUTLINE:
Patients complete the DASH and FACT-B questionnaires over 30-45 minutes.
- Conditions
- Musculoskeletal Complication, Recurrent Breast Carcinoma, Stage IA Breast Cancer, Stage IB Breast Cancer, Stage IIA Breast Cancer, Stage IIB Breast Cancer
- Being tested
- Quality-of-Life Assessment, Questionnaire Administration, Medical Chart Review
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality-of-Life AssessmentProcedure or surgery
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
Medical Chart ReviewOther
Also called Chart Review
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Supportive care (musculoskeletal screening, quality of life) | Experimental | Patients complete the DASH and FACT-B questionnaires over 30-45 minutes. Receives: Procedure: Quality-of-Life Assessment; Other: Questionnaire Administration; Other: Medical Chart Review |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients' upper extremity functionally 1 to 10 years after treatment using DASH score
DASH scores ranges from 0-100 with 1 being the least disability and 100 indicating the most disability. Means and standard deviation of the DASH will be calculated separately for patients with stable metastatic disease and those without metastatic diseases. These means will be compared with the general population.
Measured: Baseline
Patients' perception of quality of life (QOL) 1 to 10 years after treatment using the FACT-B score
The total FACT-B score ranks from 0-144, with a high score indicating a better QOL. Means and standard deviation of the FACT-B will be calculated separately for patients with stable metastatic disease and those without metastatic diseases. These means will be compared with the general population.
Measured: Baseline
Discrepancy between the presence of physical impairments and patients' perception of QOL assessed using DASH and FACT-B scores
Using the distribution of the DASH and FACT-B scores reported in general population based studies, the percentile rank of each patient's DASH or FACT-B score will be calculated. Given that a higher DASH score indicates worse disability while a higher FACT-B score means a better quality of life, the percentile ranks for DASH will be subtracted from 100 and the remainder will be used as the percentile ranks for DASH for analyses purposes.
Measured: Baseline
Time effect in the DASH score 1 to 10 years following treatment
A linear regression model will be used to examine whether there is a time effect in the DASH score with DASH being the independent variable and time after treatment being the predictive variable. Other factors that will also be investigated as affecting DASH score will include whether or not a patient had full axillary lymph node dissection or sentinel lymph node dissection, or whether or not a patient received radiation therapy or chemotherapy, etc. Interaction between these main effects and time will be included to assess differences in time effect.
Measured: Baseline
Time effect in the FACT-B score 1 to 10 years following treatment
A linear regression model will be used to examine whether there is a time effect in the FACT-B score with FACT-B score being the independent variable and time after treatment being the predictive variable. Other factors that will also be investigated as affecting FACT-B score will include whether or not a patient had full axillary lymph node dissection or sentinel lymph node dissection, or whether or not a patient received radiation therapy or chemotherapy, etc. Interaction between these main effects and time will be included to assess differences in time effect.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2015 (estimated)
- Study start1 Oct 2012
- Primary completion2 Sep 2015
- Study completion21 Oct 2016
Why it stopped: Study not progressing toward scientific goals
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Musculoskeletal ComplicationStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Marisa Perdomo, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02370264
- Sponsor's protocol ID
- 1B-12-4
- Other IDs
- NCI-2014-01849, HS-12-00578-CR002, HS-12-00578, 1B-12-4, P30CA014089
- Status last verified
- Apr 2017
- First submitted
- 17 Feb 2015
- Last updated
- 13 Apr 2017
- 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 13 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening for Musculoskeletal Impairments and Quality of Life in Individuals Post-Treatment for Breast Cancer
- ClinicalTrials.gov ID
- NCT02370264
- Acronym / sponsor ID
- 1B-12-4
- Conditions
- Musculoskeletal Complication, Recurrent Breast Carcinoma, Stage IA Breast Cancer, Stage IB Breast Cancer, Stage IIA Breast Cancer, Stage IIB Breast Cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study not progressing toward scientific goals
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Oct 2012 (actual)
- Primary completion
- 2 Sep 2015 (actual)
- Study completion
- 21 Oct 2016 (actual)
- First posted
- 24 Feb 2015 (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.
This pilot clinical trial studies questionnaires in identifying arms, shoulder, and neck (upper extremity) function and quality of life after treatment in patients with breast cancer. Patients may experience arms, shoulder, and neck impairments that negatively affect their functioning and quality of life after cancer-related treatment. Studying upper extremity function and quality of life in patients after breast cancer treatment may help doctors determine the prevalence and severity of long-term functional impairments and the relationship between the perception of impairments due to breast cancer treatment and its' impact on quality of life.
Detailed description
PRIMARY OBJECTIVES:
- To characterize patients' upper extremity functionality (using the Disabilities of the Arm, Shoulder and Hand [DASH] questionnaire) and their perception of quality of life (using the Functional Assessment of Cancer Therapy-Breast [FACT-B] questionnaire) one to ten years after breast cancer surgery and compare it to the general population.
II. To investigate whether patients' upper extremity functionality and their perception of quality of life after completion of breast cancer treatment changes over the duration of time between 1 -10 years after breast cancer surgery.
III. To characterize patient perception of the impact of breast cancer on their quality of life in relation to current upper-extremity functionality 1-10 years after breast cancer surgery.
IV. To characterize patients' upper extremity functionality (using the DASH questionnaire) and their perception of the impact of breast cancer on their quality of life (using the FACT-B questionnaire) in a sub group of individuals with stable metastatic breast cancer 1-10 years after initial diagnosis and surgery.
SECONDARY OBJECTIVES:
- To assist the multidisciplinary team to identify musculoskeletal barriers (if any) that impact a patient's long-term recovery with respect to the breast cancer treatments they have received.
II. To assist in developing and implementing a physical therapy component within the Personalized Medicine to Breast Cancer Care Plan; this includes early detection of potential physical barriers, physical therapy intervention models, and development of survivorship planning for cancer-related musculoskeletal impairments.
OUTLINE:
Patients complete the DASH and FACT-B questionnaires over 30-45 minutes.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive care (musculoskeletal screening, quality of life) | Experimental | Procedure: Quality-of-Life Assessment, Other: Questionnaire Administration, Other: Medical Chart ReviewPatients complete the DASH and FACT-B questionnaires over 30-45 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- All patients with a history of breast cancer surgery either lumpectomy, mastectomy, axillary node dissection or sentinel node biopsy at least one year ago and received either radiation therapy or chemotherapy or both
- Patients with no active disease; (as defined as no detectable disease)
- Patients with stable metastatic disease which is defined as (metastatic tumor demonstrates no increase in volume, tumor size or diameter and no evidence of new lesions, have been identified during last assessment by medical oncologist/radiologist or surgeons)
- Signed informed consent
Key exclusion criteria (6 listed)
- Survivors of breast cancer that have not received either breast surgery or radiation therapy
- Patients with known cognitive impairments
- Individuals with progressive metastatic disease in which the tumor has increased in size, volume and diameter or evidence of new lesions, as noted by medical oncologists, radiologists and surgeons
- individuals who are non-ambulatory
- Women who self-report to be pregnant
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 |
|---|---|---|
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Procedure or surgery | Supportive care (musculoskeletal screening, quality of life) |
| Questionnaire AdministrationAncillary studies | Other | Supportive care (musculoskeletal screening, quality of life) |
| Medical Chart ReviewAlso: Chart ReviewAncillary studies | Other | Supportive care (musculoskeletal screening, quality of life) |
Primary outcome
Patients' upper extremity functionally 1 to 10 years after treatment using DASH score
Time frame: Baseline
DASH scores ranges from 0-100 with 1 being the least disability and 100 indicating the most disability. Means and standard deviation of the DASH will be calculated separately for patients with stable metastatic disease and those without metastatic diseases. These means will be compared with the general population.
Patients' perception of quality of life (QOL) 1 to 10 years after treatment using the FACT-B score
Time frame: Baseline
The total FACT-B score ranks from 0-144, with a high score indicating a better QOL. Means and standard deviation of the FACT-B will be calculated separately for patients with stable metastatic disease and those without metastatic diseases. These means will be compared with the general population.
Discrepancy between the presence of physical impairments and patients' perception of QOL assessed using DASH and FACT-B scores
Time frame: Baseline
Using the distribution of the DASH and FACT-B scores reported in general population based studies, the percentile rank of each patient's DASH or FACT-B score will be calculated. Given that a higher DASH score indicates worse disability while a higher FACT-B score means a better quality of life, the percentile ranks for DASH will be subtracted from 100 and the remainder will be used as the percentile ranks for DASH for analyses purposes.
Time effect in the DASH score 1 to 10 years following treatment
Time frame: Baseline
A linear regression model will be used to examine whether there is a time effect in the DASH score with DASH being the independent variable and time after treatment being the predictive variable. Other factors that will also be investigated as affecting DASH score will include whether or not a patient had full axillary lymph node dissection or sentinel lymph node dissection, or whether or not a patient received radiation therapy or chemotherapy, etc. Interaction between these main effects and time will be included to assess differences in time effect.
Time effect in the FACT-B score 1 to 10 years following treatment
Time frame: Baseline
A linear regression model will be used to examine whether there is a time effect in the FACT-B score with FACT-B score being the independent variable and time after treatment being the predictive variable. Other factors that will also be investigated as affecting FACT-B score will include whether or not a patient had full axillary lymph node dissection or sentinel lymph node dissection, or whether or not a patient received radiation therapy or chemotherapy, etc. Interaction between these main effects and time will be included to assess differences in time effect.
Results and safety
The study was stopped early (reason given: Study not progressing toward scientific goals). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2017.
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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.
Marisa Perdomo principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quality-of-Life Assessment, Questionnaire Administration and Medical Chart Review in people with Musculoskeletal Complication and Recurrent Breast Carcinoma, run by University of Southern California 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 4 inclusion and 6 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: stopped early, as of the sponsor's last update on 13 Apr 2017. 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 was stopped early (reason given: Study not progressing toward scientific goals). Results are not available in the source record.
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?
Patients' upper extremity functionally 1 to 10 years after treatment using DASH score (time frame: Baseline). 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 13 Apr 2017.