Clinical trial NCT02370264: Questionnaires in Identifying Upper Extremity Function and Quality of Life After Treatment in Patients With Breast Cancer
Official title: Screening for Musculoskeletal Impairments and Quality of Life in Individuals Post-Treatment for Breast Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Musculoskeletal Complication
Recurrent Breast Carcinoma
Stage IA Breast Cancer
Stage IB Breast Cancer
Stage IIA Breast Cancer
Stage IIB Breast Cancer
Stage IIIA Breast Cancer
Stage IIIB Breast Cancer
Stage IIIC Breast Cancer
Stage IV Breast Cancer
Therapy-Related Toxicity
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2015-02-24
Enrollment: 36
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: PRIMARY OBJECTIVES:

I. 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:

I. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Patients' upper extremity functionally 1 to 10 years after treatment using DASH score
timeFrame: Baseline
measure: Patients' perception of quality of life (QOL) 1 to 10 years after treatment using the FACT-B score
timeFrame: Baseline
measure: Discrepancy between the presence of physical impairments and patients' perception of QOL assessed using DASH and FACT-B scores
timeFrame: Baseline
measure: Time effect in the DASH score 1 to 10 years following treatment
timeFrame: Baseline
measure: Time effect in the FACT-B score 1 to 10 years following treatment
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: USC Norris Comprehensive Cancer Center
state: California
Study officials:
affiliation: University of Southern California
name: Marisa Perdomo
role: PRINCIPAL_INVESTIGATOR
References: