Breast Cancer Clinical Trial
Official title:
Improving Psychosocial Quality of Life in Women With Advanced Breast Cancer
Verified date | July 2017 |
Source | Northwestern University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Through a patient participation aid (PPA) the investigators hope to improve the psychosocial well-being of women diagnosed with metastatic breast cancer by empowering them to be active participants in clinical encounters.
Status | Completed |
Enrollment | 150 |
Est. completion date | May 19, 2017 |
Est. primary completion date | May 19, 2017 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 21 Years and older |
Eligibility |
Inclusion Criteria: - female patients with metastatic breast cancer seeing one of the study physicians at one of the identified study clinics - age 21 or older - having suspected progression of metastatic disease Exclusion Criteria: - patients with an uncorrectable hearing impairment or having limited English proficiency, as this would adversely affect their ability to communicate with the physician - patients with uncorrectable vision impairment, as this would make it impractical for the patient to read the intervention - patients too ill to meaningfully converse with the physician |
Country | Name | City | State |
---|---|---|---|
United States | Feist-Weiller Cancer Center | Shreveport | Louisiana |
United States | H Lee Moffitt Comprehensive Cancer Center | Tampa | Florida |
Lead Sponsor | Collaborator |
---|---|
Northwestern University | American Cancer Society, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Decision Regret Scale | Collected at post-visit, and follow-ups, this measures the patient's regret and feelings regarding the most recent treatment-related decision | Change in decision regret from pre-visit at 3 months post-visit | |
Primary | Functional Assessment of Cancer Therapy - General (FACT-G) | Evaluated at 30 minutes prior to, one week after, and 3 months after the patients visit with their doctor, this measure collects scales of the social and family well-being, emotional well-being, and functional well-being. | Change in functional assessment of cancer therapy from pre-visit at 3 months post-visit | |
Secondary | Rapid Estimate of Adult Literacy in Medicine (REALM-SF) | A 7-item word recognition test to provide clinicians with a valid quick assessment of patient health literacy. | Pre-Visit |
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