GIST and Memory and Attention Adaptation Training (NCT04879979) | Clinical Trial Compass
TerminatedNot Applicable
GIST and Memory and Attention Adaptation Training
Stopped: Slow enrollment
United States2 participantsStarted 2021-01-12
Plain-language summary
Cognitive-behavioral therapy (CBT) has been found to be efficacious in the treatment of cancer-related cognitive impairment (CRCI). Memory and Attention Adaptation Training (MAAT) has been evaluated in previous clinical trials with samples of breast cancer survivors and found effective at reducing cancer-related cognitive impairment. MAAT has been demonstrated to be efficacious when it is delivered via videoconference.The use of telehealth delivery enhances access to cancer survivorship care and reduces time and travel burden among cancer survivors, especially those who live in rural and/or underserved areas where cancer survivor services are less available.
People with a diagnosis of gastrointestinal stromal tumors also experience self-reported cancer-related cognitive impairment. In order to determine if MAAT can sufficiently treat CRCI among people with gastrointestinal stromal tumors (GIST), we propose a trial of MAAT to determine its initial level of effectiveness in improving both self-reported cognitive impairments and objective neuropsychological test performance in GIST patients.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age 18 and above;
✓. Diagnosis of Gastrointestinal stromal tumor (GIST);
✓. At least 1 year post-initiation of TKI therapy;
✓. Report cognitive problems of memory and concentration attributed to GIST and/or treatment with a score of 10 or below on the FACT-Cog Impact on Quality of Life Scale;
✓. Able to speak and read English;
✓. Able to provide IRB-approved written informed consent; and
✓. Willingness to use videoconferencing and complete phone-based neurocognitive assessments
Exclusion criteria
✕. Previous treatment with a tyrosine kinase inhibitor medication for a non-GIST diagnosis
✕. Previous CNS radiation, intrathecal therapy, or CNS-involved surgery;
✕. Previous cancer history with the exception of non-melanoma skin cancer;
What they're measuring
1
California Verbal Learning Test-3 (CVLT-3)
Timeframe: After 8 weekly MAAT visits (or up to 12 weeks if weekly visits are rescheduled)
2
Controlled Oral World Association Test (COWAT)
Timeframe: After 8 weekly MAAT visits (or up to 12 weeks if weekly visits are rescheduled)
3
Symbol Digit Modalities Test (SDMT)
Timeframe: After 8 weekly MAAT visits (or up to 12 weeks if weekly visits are rescheduled)
✕. Previous exposure to chemotherapy with another cancer or due to other medical condition (e.g., methotrexate exposure for treatment of rheumatoid arthritis);
✕. Scoring 3 or below on the 6-item cognitive screen designed to detect severe memory disorders;1
✕. Significant neurodevelopmental, neurobehavioral, or medical risk factors likely to affect cognitive functioning (e.g., history of neurological disorder, stroke, traumatic brain injury greater than mild severity, such as loss of consciousness \>30 minutes, medical disorder that is unstable or likely to affect cognition such as metabolic disorder, heart attack, uncontrolled diabetes or endocrine dysfunction);
✕. Current severe DSM-5 mental disorder criteria, including but not limited to neurodevelopmental, substance abuse, mood, anxiety, or psychotic disorders