Efficacy of MBSR Treatment of Cognitive Impairment Among Breast Cancer Survivors

Completed · Not applicable

Conditions studied: Breast Cancer

In brief

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 cancer survivors. The study will employ a three group randomized design that will (1) evaluate the extent to which MBSR(BC) compared to the Breast Cancer-Education Support (BCES) program or Usual Care (UC) improves cognitive functioning among breast cancer survivors off treatment; (2) determine if improvements in cognitive functioning achieved from MBSR(BC) are mediated through increased mindfulness and decreased rumination and stress; (3) evaluate genetic variants as moderators of MBSR(BC) on improvements in CI; and (4) determine the impact of MBSR(BC) on healthcare utilization and costs, in addition it will be delivered to a sub-group in Spanish. If shown to be efficacious, the possibility exists of utilizing this intervention in other types of cancers as well as non-cancer health-related disorders in order to minimize the morbidity experienced by these populations.

Key facts

Study ID

NCT02786797

Run by

University of South Florida

People needed

214

Starts

2016-03-07

Expected to finish

2020-07-01

Last updated by the study team

2020-07-28

Who can join

Age: 21 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Sarasota Memorial Hospital — Sarasota, Florida, United States
• Moffitt Cancer Center — Tampa, Florida, United States
• University of South Florida — Tampa, Florida, United States
• USF Health Carol and Frank Morsani Center — Tampa, Florida, United States
• Florida Hospital Tampa — Tampa, Florida, United States

Full record on ClinicalTrials.gov

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