An official website of the United States government
Video Conference Delivered Cognitive-Behavioral Therapy for Chemotherapy-Related Cognitive Dysfunction in Patients with Stage I-III Breast Cancer
Trial Status: active
This clinical trial studies the effect of a video conference-delivered cognitive-behavioral therapy (CBT), Memory and Attention Adaptation Training (MAAT), for chemotherapy-related cognitive dysfunction in patients with stage I-III breast cancer. Memory and attention problems can be a consequence of cancer and cancer treatment for some breast cancer survivors, including those who have received chemotherapy. Researchers want to identify an effective treatment for cognitive problems in stage I-III breast cancer survivors that can be incorporated into routine care.
Inclusion Criteria
Diagnosis of stage I-III breast cancer
1-5 years post-treatment and currently disease free
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, and discriminates high and low PCI scores in prior research)
Able to speak and read English
Age > 18
Able to provide Institutional Review Board (IRB)-approved written informed consent
Willing to use videoconferencing
Exclusion Criteria
Previous central nervous system (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 traumatic brain injury [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 Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) mental disorder criteria, including but not limited to neurodevelopmental, substance abuse, mood (e.g., Major Depression), anxiety, or psychotic disorders
Scoring 3 or below on the 6-item cognitive screen designed to detect severe memory disorders
Severe uncorrected sensory impairment (severe hearing or visual impairment)
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04586530.
Locations matching your search criteria
United States
Indiana
Indianapolis
Indiana University/Melvin and Bren Simon Cancer Center
I. Confirm efficacy of MAAT (video conference-delivered) in a multi-site randomized controlled trial (RCT) utilizing an active control condition (supportive therapy; [ST]) with the primary outcome of the perceived cognitive impairments (PCI) subscale of the FACT-Cog.
II. Confirm efficacy of MAAT (video conference-delivered) with outcomes of objective neurocognitive function.
III. Investigate impact of MAAT on working memory function as assessed by fMRI.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo CBT using MAAT delivered through video conferencing composed of 8, 45 minute sessions to complete a survivor workbook over 8 weeks. Patients may also undergo fMRI on study.
ARM II: Patients receive supportive therapy through video conferencing composed of 8, 45 minute sessions to complete over 8 weeks. Patients may also undergo fMRI on study.
Trial PhaseNo phase specified
Trial Typetreatment
Lead OrganizationUniversity of Pittsburgh Cancer Institute (UPCI)
