Questionnaires in Identifying Upper Extremity Function and Quality of Life After Treatment in Patients With Breast Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-01

Study Completion Date

2016-10-21

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Supportive care (musculoskeletal screening, quality of life)

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

Group Type EXPERIMENTAL

Quality-of-Life Assessment

Intervention Type PROCEDURE

Ancillary studies

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Medical Chart Review

Intervention Type OTHER

Ancillary studies

Interventions

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Quality-of-Life Assessment

Ancillary studies

Intervention Type PROCEDURE

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Medical Chart Review

Ancillary studies

Intervention Type OTHER

Other Intervention Names

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Quality of Life Assessment Chart Review

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No