Clinical Trial 23558
- Cancer Type: Malignant Hematology
- Study Type: Supportive Care
- NCT#: NCT07030400
- Phase: N/A
- Principal Investigator: Tinsley Vance, Sara
- 813-745-6100
- Or 1-800-679-0775
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Overview
Study Title:
Predictors of Health-Related Quality of Life in Adults with Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma.
Summary:
The study aims to improve our understanding of how quality of life, fatigue, and symptoms change over 2 years when participants are treated for chronic lymphocytic leukemia or small lymphocytic lymphoma. We will compare two types of treatment to help future patients with chronic lymphocytic leukemia or small lymphocytic lymphoma know what to anticipate.
Objective:
The aims of the study are to: 1) Compare the differences in HRQOL scores measured by the Functional Assessment of Cancer Therapy Leukemia version for patients receiving BTKi, and BCL2i within 7 days of beginning treatment and at days 30,60, 90, 180, 1 year, 1.5 years, and 2 years following initiation of treatment; 2) Evaluate HRQOL predictors of CLL patients from age, comorbidity, fatigue, symptoms, and disease characteristics; 3) Test the moderating effect of treatment with age, comorbidity, and fatigue on HRQOL.
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Inclusion Criteria
- Key Inclusion Criteria:
- All patients with pathology-confirmed diagnoses of CLL who are within seven days of starting treatment with a BTKi +/- an anti-CD 20 monoclonal antibody or BCL2i with Obinutuzumab treatment will be included.
- Subjects must be able to read and speak English or Spanish at the 8th grade level.
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Exclusion Criteria
- Key Exclusion Criteria:
- Patients with dementia, traumatic brain injury, or individuals with central nervous system involvement of their leukemia will be excluded from study participation.
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