Telehealth and Memory Study (NCT04586530) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Telehealth and Memory Study
United States220 participantsStarted 2021-03-18
Plain-language summary
The overall purpose of this trial is to confirm the efficacy of Memory and Attention Adaptation Training (MAAT), a cognitive-behavioral therapy (CBT) for treatment of chemotherapy-related cognitive dysfunction among (female or male) breast cancer survivors. This is a multi-center, multi-clinician randomized control trial (MAAT vs. supportive therapy attention control condition). This trial will also evaluate a sub-sample of survivors pre-and post treatment with functional magnetic resonance imaging (fMRI) in a working memory task to evaluate pre-to-post treatment brain activation patterns to elucidate underlying mechanisms of clinical therapeutic change.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Diagnosis of stage I-III breast cancer
✓. 1-5 years post-treatment and currently disease free
✓. Treatment involved adjuvant or neoadjuvant chemotherapy
✓. Report cognitive problems of memory and concentration attributed to chemotherapy with a score of 10 or below on the FACT-Cog Impact on Quality of Life Scale (a score \~1SD below pre-chemotherapy treatment norms; this criterion was used in our prior R21 study, ensures a clinically meaningful level of cognitive concerns,41 and discriminates high and low PCI scores in prior research42)
✓. Able to speak and read English
✓. Age \>18
✓. Able to provide IRB-approved written informed consent
✓. Willing to use videoconferencing.
Exclusion criteria
✕. Previous CNS radiation, intrathecal therapy, or CNS-involved surgery
What they're measuring
1
FACT-Cog PCI
Timeframe: At Baseline, Post-Treatment (8 weeks) and 6-Month Follow-up
. Previous cancer history with the exception of non-melanoma skin cancer
✕. Previous exposure to chemotherapy with another cancer or due to other medical condition (e.g., methotrexate exposure for treatment of rheumatoid arthritis)
✕. Significant neurodevelopmental, neurobehavioral, or medical risk factors likely to affect cognitive functioning (e.g., history of neurological disorder or TBI of 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 or stroke, uncontrolled diabetes or endocrine dysfunction)
✕. Currently meeting DSM-5 mental disorder criteria, including but not limited to neurodevelopmental, substance abuse, mood (e.g., Maj.Dep), anxiety, or psychotic disorders
✕. Scoring 3 or below on the 6-item cognitive screen designed to detect severe memory disorders;43
✕. Severe uncorrected sensory impairment (severe hearing or visual impairment)