Mobile Device CBT for Chemotherapy-Related Cognitive Dysfunction: A Multi-Center Randomized Controlled Trial

摘要

ABSTRACT 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.