Chemotherapy-related Cognitive Dysfunction Clinical Trial
— TAMSOfficial title:
Mobile Device CBT for Chemotherapy-Related Cognitive Dysfunction: A Multi-Center Randomized Controlled Trial
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.
| Status | Recruiting |
| Enrollment | 200 |
| Est. completion date | May 31, 2025 |
| Est. primary completion date | December 31, 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: 1. Diagnosis of stage I-III breast cancer 2. 1-5 years post-treatment and currently disease free 3. Treatment involved adjuvant or neoadjuvant chemotherapy 4. 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) 5. Able to speak and read English 6. Age >18 7. Able to provide IRB-approved written informed consent 8. Willing to use videoconferencing. Exclusion Criteria: 1. Previous CNS radiation, intrathecal therapy, or CNS-involved surgery 2. Previous cancer history with the exception of non-melanoma skin cancer 3. Previous exposure to chemotherapy with another cancer or due to other medical condition (e.g., methotrexate exposure for treatment of rheumatoid arthritis) 4. 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) 5. Currently meeting DSM-5 mental disorder criteria, including but not limited to neurodevelopmental, substance abuse, mood (e.g., Maj.Dep), anxiety, or psychotic disorders 6. Scoring 3 or below on the 6-item cognitive screen designed to detect severe memory disorders;43 7. Severe uncorrected sensory impairment (severe hearing or visual impairment) |
| Country | Name | City | State |
|---|---|---|---|
| United States | Indiana University | Indianapolis | Indiana |
| United States | UPMC Hillman Cancer Center | Pittsburgh | Pennsylvania |
| Lead Sponsor | Collaborator |
|---|---|
| University of Pittsburgh | National Cancer Institute (NCI), National Institutes of Health (NIH) |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | FACT-Cog PCI | The FACT-Cog is a 37-item self-report measure that uses 5- point (0-4) Likert-type ratings that produce four scales: 1) Impact on quality of life; 2) Perceived cognitive impairments; 3) Comments from others; and 3) Perceived cognitive abilities. Higher scores indicate better function and quality of life on each scale. While each scale is scored and interpreted separately, they comprise the total Fact-cog assessment. The FACT-Cog has good evidence of reliability and construct validity. We are assessing change in PCI -- from baseline to post-treatment, to 6-month follow-up-- as our primary measure of outcome. | At Baseline, Post-Treatment (8 weeks) and 6-Month Follow-up | |
| Secondary | California Verbal Learning Test-3 (CVLT-3) | The California Verbal Learning Test is a neuropsychological assessment of episodic verbal and working memory and processing speed. Participants listen to series of words and is then asked to recall the terms and the category to which they belong. This assessment attempts to measure how much a subject learned and also reveal strategies employed and the types of errors made. Higher CVLT-3 scores are associated with better memory and processing function. | At Baseline, Post-Treatment (8 weeks) and 6-Month Follow-up | |
| Secondary | Controlled Oral Word Association Test (COWAT) | The Controlled Oral Word Association Test (COWAT), is a neuropsychological measure of verbal fluency. The COWAT consists of three word conditions. Participants are asked to produce as many words as they can that begin with the F, A, or S within a 1 minute time period. The total number of words that the individual is able to produce provides a score. Typically, if someone scores less than 17 words, the test administrator will use additional tests to further evaluate cognition. | At Baseline, Post-Treatment (8 weeks) and 6-Month Follow-up | |
| Secondary | Digit Span test | The Digit Span test is a neurocognitive subset of both the Wechsler Adult Intelligence Scale (WAIS) and the Wechsler Memory Scales (WMS) that assesses working memory. Participants read a sequence of numbers and are asked to repeat the same sequence back to the examiner in order (forward span) or in reverse order (backward span). This assessment generates three "raw" scores and one overall age-appropriate normed (standard) score. Higher scores indicate better working memory and neurocognitive function. | At Baseline, Post-Treatment (8 weeks) and 6-Month Follow-up | |
| Secondary | Symbol Digit Modalities Test (SDMT) | The Symbol Digit Modalities Test (SDMT) is a neurocognitive screening instrument used to assess neurological dysfunction. Participants are required to use a coded key to match nine abstract symbols paired with numerical digits. Ten (10) practice items before commencing the test. The final score is the correct number of substitutions in 90 seconds, and scores range between 0 and 110. Higher scores indicate better neurocognitive functioning. | At Baseline, Post-Treatment (8 weeks) and 6-Month Follow-up | |
| Secondary | functional Magnetic Resonance Imaging (fMRI) | fMRI assessment of a working memory task (N-Back) will assess brain activation patterns through detection in bloodflow changes. The fMRI N-Back working memory task has been demonstrated to reflect increased activation in response to MAAT treatment among individuals with traumatic brain injury. | At Baseline and Post-Treatment (8 weeks) |