An interventional study of Cognitive Intervention and Educational Intervention in Breast Carcinoma, Cancer Survivor and Cognitive Side Effects of Cancer Therapy, sponsored by University of Washington. Completed at 1 site in United States. Open to female participants aged 21 Years to 90 Years. Per ClinicalTrials.gov, last updated 2019-11-08.
Sponsored by University of Washington · Not applicable, Interventional, and Supportive care
The purpose of this study is to examine thinking abilities, mood, and quality of life in cancer survivors before and after an 8-week group-based memory and thinking skills workshop. Research participants will include people treated for cancer in the past. Researchers would like to know if there is a relationship between baseline performance on timed attention and memory tasks before receiving memory and thinking skills workshop designed to improve cognition, and performance on such tasks after the workshop.
PRIMARY OBJECTIVES:
I. To objectively assess changes in cognitive performance and quality of life (QOL) pre and post participation in a cognitive rehabilitation intervention in gynecologic and breast cancer survivors who have undergone chemotherapy.
II. To measure changes in neural function as measured by functional magnetic resonance imaging (fMRI) blood oxygenation level dependent (BOLD) signal and corresponding behavioral responses while performing cognitive tasks.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I (Skills workshop): Patients participate in a memory and thinking skills workshop once weekly for 7 weeks. Patients complete cognitive tests and questionnaires at pre-baseline (Visit 1), baseline (Visit 2), and 7 weeks (Visit 3).
ARM II (Education workshop): Patients participate in education workshop for 7 weeks 1-hour duration group focusing on the brain and cognition. Patients complete cognitive tests and questionnaires at pre-baseline (Visit 1), baseline (Visit 2), and 7 weeks (Visit 3).
12,547 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 20 is below the median of 72 across 9,305 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →University of Washington is the lead sponsor of 1,397 studies on the registry; 225 are open to participants now.
Of its 154 completed or terminated interventional studies of FDA-regulated products, 132 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
For the subset of participants undergoing neuroimaging:
Patients participate in a memory and thinking skills workshop once weekly for 7 weeks. Patients complete cognitive tests and questionnaires at pre-baseline (Visit 1), baseline (Visit 2), and 7 weeks (Visit 3).
Other: Cognitive Intervention · Procedure: Functional Magnetic Resonance Imaging · Other: Memory Intervention · Other: Quality-of-Life Assessment · Other: Questionnaire Administration
Patients participate in 7 weekly 1-hour group workshops focusing on increasing knowledge and education on the brain and cognition. Patients complete cognitive tests and questionnaires at pre-baseline (Visit 1), baseline (Visit 2), and 7 weeks (Visit 3). Patients are then given the option to participate in the memory and thinking skills workshop.
Other: Educational Intervention · Procedure: Functional Magnetic Resonance Imaging · Other: Quality-of-Life Assessment · Other: Questionnaire Administration
Participate in memory and thinking skills workshop
Participate in workshops focusing on increasing knowledge and education on the brain and cognition
Also known as: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Undergo functional neuroimaging
Also known as: fMRI, FUNCTIONAL MRI
Participate in memory and thinking skills workshop
Ancillary studies
Also known as: Quality of Life Assessment
Ancillary studies
Change in score on the FACT-Cog-addendum, quality of life (SF-36) questionnaire
Participants respond to questions about their quality of life. The resulting score pre-workshop is compared to the score at 7 weeks post-workshop.
Time frame: Pre-workshop to 7 weeks post-workshop
Change in score on the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) questionnaire
Participants respond to questions about their perceived cognitive function. The resulting score pre-workshop is compared to the score at 7 weeks post-workshop.
Time frame: Pre-workshop to 7 weeks post-workshop
Changes in neural function measured by fMRI BOLD signal
MRI functional imaging assessments while performing cognitive tasks.
Time frame: Pre-workshop to 7 weeks post-workshop
This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.
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