Telehealth and Memory Study (TAMS)
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|ClinicalTrials.gov Identifier: NCT04586530|
Recruitment Status : Recruiting
First Posted : October 14, 2020
Last Update Posted : April 25, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Chemotherapy-related Cognitive Dysfunction||Behavioral: Memory and Attention Adaptation Training (MAAT) Behavioral: Supportive Therapy (ST)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Mobile Device CBT for Chemotherapy-Related Cognitive Dysfunction: A Multi-Center Randomized Controlled Trial|
|Actual Study Start Date :||March 18, 2021|
|Estimated Primary Completion Date :||December 31, 2024|
|Estimated Study Completion Date :||May 31, 2025|
Experimental: Memory and Attention Adaptation Training (MAAT)
A videoconference-delivered cognitive-behavioral therapy (CBT) for treatment of chemotherapy-related cognitive dysfunction (CRCD) among cancer survivors consisting of 8 weekly 45-minute visits with a survivor workbook, that targets: 1) enhancement of survivor self-awareness of "at risk" situations where memory failures occur; 2) emotion regulation through modification of survivor causal attributions and negative cognitive appraisals of memory failures; and 3) training in compensatory strategies to improve performance on daily tasks for which memory.
Behavioral: Memory and Attention Adaptation Training (MAAT)
A cognitive-behavioral therapy (CBT) for treatment of chemotherapy-related cognitive dysfunction (CRCD) among cancer survivors.
Active Comparator: Supportive Therapy (ST)
Standard attention control condition therapy for treatment of chemotherapy-related cognitive dysfunction (CRCD) among cancer survivors consisting of 8, 45-minutes visits. ST, emphasizes "non-specific" psychotherapeutic factors of clinician-participant alliance: empathy, support and warmth. ST will be directed at concerns with cancer survivorship and CRCD. Clinicians will set expectations with ST participants that they will be provided validation of experience, support, and encouragement of building their own coping resources if asked directly about what to do about cognitive problems. ST emphasizes reflective listening to help deepen knowledge of the emotional experience of the participant.
Behavioral: Supportive Therapy (ST)
Standard attention control condition therapy for treatment of chemotherapy-related cognitive dysfunction (CRCD) among cancer survivors.
- FACT-Cog PCI [ Time Frame: At Baseline, Post-Treatment (8 weeks) and 6-Month Follow-up ]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.
- California Verbal Learning Test-3 (CVLT-3) [ Time Frame: At Baseline, Post-Treatment (8 weeks) and 6-Month Follow-up ]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.
- Controlled Oral Word Association Test (COWAT) [ Time Frame: At Baseline, Post-Treatment (8 weeks) and 6-Month Follow-up ]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.
- Digit Span test [ Time Frame: At Baseline, Post-Treatment (8 weeks) and 6-Month Follow-up ]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.
- Symbol Digit Modalities Test (SDMT) [ Time Frame: At Baseline, Post-Treatment (8 weeks) and 6-Month Follow-up ]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.
- functional Magnetic Resonance Imaging (fMRI) [ Time Frame: At Baseline and Post-Treatment (8 weeks) ]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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- Previous CNS radiation, intrathecal therapy, or CNS-involved surgery
- 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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04586530
|Contact: Audrey Kreitzemail@example.com|
|Contact: Ella Chobanfirstname.lastname@example.org|
|United States, Indiana|
|Indianapolis, Indiana, United States, 46202|
|Contact: Brenna C McDonald, PsyD 317-963-7502 email@example.com|
|Contact: Jessica Bailey, BS 317-963-7516 firstname.lastname@example.org|
|Principal Investigator: Brenna C McDonald, PsyD|
|United States, Pennsylvania|
|UPMC Hillman Cancer Center||Recruiting|
|Pittsburgh, Pennsylvania, United States, 15232|
|Contact: Robert J Ferguson, PhD 412-623-5888 email@example.com|
|Contact: Audrey Kreitz, BS 412-623-5975 firstname.lastname@example.org|
|Principal Investigator: Robert J Ferguson, PhD|
|Responsible Party:||Robert J Ferguson, PhD, Assistant Professor of Medicine, University of Pittsburgh|
|Other Study ID Numbers:||
R01CA244673-01A1 ( U.S. NIH Grant/Contract )
|First Posted:||October 14, 2020 Key Record Dates|
|Last Update Posted:||April 25, 2022|
|Last Verified:||April 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Yes|
|Plan Description:||NIH funded study - public database|
Statistical Analysis Plan (SAP)
|Time Frame:||We anticipate a completed data set in approximately December of 2025 and will make de-identified data available to qualified investigators for a period of 3 years after publication of primary results in a peer reviewed journal.|
|Access Criteria:||De-identified data sharing criteria include (for quality assurance): 1) Qualified researchers who have obtained IRB approval from their institution; 2) Sign a Data Use Agreement (DUA); 3) Agree to NIH, IRB policies and HIPAA requirements regarding privacy, data security and ethical practices; 4) The DUAs will ensure that data will be used only for the specific research purposes outlined in the DUA; 5) No personally identifiable or protected health information will be shared outside of University of Pittsburgh/Indiana University research staff who have a need to know this information for the purposes of the study; 6) Individual participant's data will not be disseminated; 7) Data access will be protected under security measures including encryption and password protection, and that the data will be destroyed or returned to the University of Pittsburgh/Indiana University study team after completion of relevant analyses. Collaborative analyses with project investigators are encouraged.|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Memory and Attention Adaptation Training (MAAT)
Chemotherapy-Related Cognitive Impairment
Drug-Related Side Effects and Adverse Reactions