||5R01CA244673-02 Interpret this number
||University Of Pittsburgh At Pittsburgh
||Mobile Device Cbt for Chemotherapy-Related Cognitive Dysfunction: a Multi-Center Randomized Controlled Trial
The proposed research will examine the efficacy of a videoconference-delivered cognitive-behavioral therapy
(CBT), Memory and Attention Adaptation Training (MAAT), in a large, multi-site, randomized controlled trial
(RCT) for breast cancer survivors with chemotherapy-related cognitive dysfunction (CRCD). Outcome
measures include assessment of both subjective and objective cognitive functioning. Another goal of the
research is to use functional MRI (fMRI) to evaluate underlying changes in brain activation patterns that are
believed to be associated with positive effects of MAAT. Recent analyses by the MPIs have demonstrated
enhanced working memory-related cortical activation following MAAT treatment among individuals with
traumatic brain injury (TBI). The present work seeks to determine if the same activation patterns occur post-
treatment with MAAT vs. an attention control condition (supportive therapy; ST) in breast cancer survivors. If
successful, the results of this work will: (1) produce an evidence-based treatment that can be immediately
disseminated to cancer centers and other healthcare settings to treat CRCD and (2) help inform further
treatment development through improved understanding of mechanisms that promote CRCD recovery. MAAT
utilizes a non-drug, CBT approach to enhance self-management, behavioral adaptation, and coping with late
cognitive effects of chemotherapy. MAAT has been evaluated in four previous small trials: 1) a single-group
pilot study (NCI R03); 2) a randomized waitlist control trial (Lance Armstrong Foundation); 3) and a randomized
trial with an active control group condition (supportive therapy; ST) in which both MAAT and ST interventions
were delivered via videoconference (NCI R21). Research with breast cancer survivors shows promising results
with improved subjective and objective cognitive function. In a fourth trial, individuals with cognitive symptoms
after traumatic brain injury (TBI) showed improved cognitive function when treated with MAAT alone or in
combination with methylphenidate relative to those receiving behavioral or pill placebo. While research to date
is favorable, MAAT has not been evaluated in a large RCT with independent, multiple clinicians or at multiple
sites to establish efficacy and generalizability in the breast cancer population. Only one clinician has delivered
MAAT in previous breast cancer survivorship studies and the sample sizes were small. Therefore, the
proposed study makes important methodological improvements using a larger sample size in a multi-site,
multi-clinician RCT with an ST control condition, and reduces survivorship travel burden by delivering both
MAAT and ST over secured videoconference link. The proposed study therefore has the potential for great
clinical and scientific impact, and will help offer effective non-pharmacologic treatment that can be widely
disseminated using mobile technology, especially to rural survivors, to reduce travel and time burden and
improve survivorship care.
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