Status:
COMPLETED
Efficacy of MBSR Treatment of Cognitive Impairment Among Breast Cancer Survivors
Lead Sponsor:
University of South Florida
Conditions:
Breast Cancer
Eligibility:
FEMALE
21+ years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate MBSR(BC), an intensive meditation-based stress reduction intervention, in order to determine its efficacy in improving cognitive functioning among breast cance...
Detailed Description
Due to improved detection and treatment, survival rates among breast cancer survivors have increased. However, breast cancer survivors may experience cognitive impairment (CI) following treatment, whi...
Eligibility Criteria
Inclusion
- Women age 21 or older who have:
- a diagnosis of stage I, II, or III breast cancer;
- completed CT or CT and radiation and are within 5 years post-treatment;
- BC patients with a previous history of another cancer who have NOT received any chemotherapy or chemotherapy and radiation, but have only received surgical treatments are eligible;
- met the screening criteria for CI through a positive response to at least 1 of 2 scaled questions from the European Organization for Research and Treatment of Cancer Quality of Life questionnaire (EORTC-QLQ) i.e. Please rate on a scale from 0 to 10, the difficulty level you have in concentrating on things, like reading a newspaper or watching television? "0" means no difficulty and "10" means very difficult. Please rate on a scale from 0 to 10, the difficulty level you have in remembering things. "0" means no difficulty and "10" means very difficult, will be included.
- Subjects must have the ability to read and speak English and Spanish at the 8th grade level or above, and survivors with mild depression, anxiety, or other psychiatric conditions will be eligible.
Exclusion
- Breast cancer survivors with a severe current psychiatric diagnosis (e.g. bipolar disorder)
- Stage 0 or Stage IV BC
- History of another primary cancer diagnosis, treated with adjuvant chemotherapy
- Previous chemotherapy
- Current diagnosed neurologic disorder
- Or a traumatic brain injury will be excluded
Key Trial Info
Start Date :
March 7 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2020
Estimated Enrollment :
214 Patients enrolled
Trial Details
Trial ID
NCT02786797
Start Date
March 7 2016
End Date
July 1 2020
Last Update
July 28 2020
Active Locations (5)
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1
Sarasota Memorial Hospital
Sarasota, Florida, United States, 34239
2
Moffitt Cancer Center
Tampa, Florida, United States, 33612
3
University of South Florida
Tampa, Florida, United States, 33612
4
USF Health Carol and Frank Morsani Center
Tampa, Florida, United States, 33612