NCT02370264

Brief 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. 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

February 17, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 24, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 2, 2015

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 21, 2016

Completed
Last Updated

April 13, 2017

Status Verified

April 1, 2017

Enrollment Period

2.9 years

First QC Date

February 17, 2015

Last Update Submit

April 11, 2017

Conditions

Musculoskeletal ComplicationRecurrent Breast CarcinomaStage IA Breast CancerStage IB Breast CancerStage IIA Breast CancerStage IIB Breast CancerStage IIIA Breast CancerStage IIIB Breast CancerStage IIIC Breast CancerStage IV Breast CancerTherapy-Related Toxicity

Outcome Measures

Primary Outcomes (5)

  • 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.

    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.

    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.

    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.

    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.

    Baseline

Study Arms (1)

Supportive care (musculoskeletal screening, quality of life)

EXPERIMENTAL

Patients complete the DASH and FACT-B questionnaires over 30-45 minutes.

Procedure: Quality-of-Life AssessmentOther: Questionnaire AdministrationOther: Medical Chart Review

Interventions

Quality-of-Life AssessmentPROCEDURE

Ancillary studies

Also known as: Quality of Life Assessment
Supportive care (musculoskeletal screening, quality of life)
Questionnaire AdministrationOTHER

Ancillary studies

Supportive care (musculoskeletal screening, quality of life)
Medical Chart ReviewOTHER

Ancillary studies

Also known as: Chart Review
Supportive care (musculoskeletal screening, quality of life)

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

USC Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Marisa Perdomo

    University of Southern California

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2015

First Posted

February 24, 2015

Study Start

October 1, 2012

Primary Completion

September 2, 2015

Study Completion

October 21, 2016

Last Updated

April 13, 2017

Record last verified: 2017-04

Locations

US(1)