Breast Cancer Clinical Trial
Official title:
Cognitive Dysfunction and the Breast Cancer Patient: A Study to Determine the Impact of Providing Information on Coping Strategies on Quality of Life
Verified date | May 2023 |
Source | Advocate Health Care |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to determine whether patients experience a better quality of life when they have received education about coping strategies for cognitive dysfunction.
Status | Completed |
Enrollment | 49 |
Est. completion date | September 1, 2019 |
Est. primary completion date | September 1, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age >18years old - Stage 0-IV breast cancer (excluding stage IV with metastasis to the brain) - Life expectancy > 3 months - Able to speak and read English fluently - Self-reported cognitive difficulties that interfere with everyday activities - Reported Memory/Cognitive changes on Distress Thermometer - Able to provide written and informed consent - Willing to complete FACT-Cog questionnaire Exclusion Criteria: - Current Cognitive Training, for example, use of brain training, physical therapy, occupational or speech therapy for the sole purpose of improving cognitive function - Recent diagnosis of Major depression or other current psychiatric disorders and are not considered stable per a current care provider - History of Dementia or Alzheimer's Disease - History of Central Nervous System (CNS) radiation, intrathecal chemotherapy, or CNS involved surgery - History of metastatic disease extending to the brain - History of traumatic brain injury - History of seizure disorder - History of thyroid disorder (Subjects that are well managed without changes in thyroid medications or doses for at least 6 months may participate in study) - Current use of illicit substances and or alcohol (including medical marijuana) - Current sleep disturbance/disorder (Subjects that are well managed without changes in sleep medications or doses for at least 6 months may participate in study). - Concurrent use of antidepressants for example, use of antidepressants for pain management or smoking cessation. (Subjects that are well managed without changes on antidepressant medications or doses for at least 6 months may participate in study). |
Country | Name | City | State |
---|---|---|---|
United States | Advocate Good Shepherd Hospital | Barrington | Illinois |
United States | Advocate Illinois Masonic Medical Center | Chicago | Illinois |
United States | Advocate Sherman Hospital | Elgin | Illinois |
United States | Advocate South Suburban Hospital | Hazel Crest | Illinois |
United States | Advocate Condell Medical Center | Libertyville | Illinois |
United States | Advocate Lutheran General Hospital | Park Ridge | Illinois |
Lead Sponsor | Collaborator |
---|---|
Advocate Health Care |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | FACT-Cog 3 questionnaire | Assess QOL with use of FACT-Cog 3 questionnaire. Then compare group 1 that was provided teaching on coping strategies to Group 2 that received current standard of care. Determine impact on quality of life between subject groups based on statistical difference in Quality of Life between Group 1 and Group 2. | 16 weeks |
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