Telehealth cognitive-behavioral therapy for cancer-related cognitive impairment: 2024 update of a model for remote clinical trial participation.

Abstract

TPS12147 Background: Cancer-related cognitive impairment (CRCI) consists of persistent memory symptoms that adversely affects survivor quality of life (QOL). Memory and Attention Adaptation Training (MAAT) is an evidence-based cognitive behavioral therapy (CBT) for CRCI with demonstrated efficacy in telehealth delivery. MAAT consists of 8 weekly (45 minute) video visits. The aims of this study are to confirm MAAT telehealth efficacy in a phase III RCT (MAAT vs Supportive Therapy; ST) across large catchment areas of two comprehensive cancer centers. A secondary aim is to evaluate treatment-induced brain activation as assessed by functional MRI (fMRI). We present remote treatment and data capture methods of this open NCI-sponsored (R01CA244673) randomized clinical trial (NCT 04586530). These methods have high success in participant accrual despite starting the trial in COVID-19 pandemic conditions and can be readily adopted to other clinical trials to enhance rural/underserved enrollment. Methods: We are enrolling 200 adult, stage I-III breast cancer survivors 1-5 years post-chemotherapy with cognitive complaints. Individuals with CNS disease, previous brain injury, dementia or psychiatric disorder are excluded. All study procedures are completed from the participant’s home (except fMRI). Eligibility screening is a structured phone interview followed by detailed informed consent online (Research Electronic Data Capture: REDCap) with phone guidance. Consented participants complete baseline brief phone-based neurocognitive assessment and validated patient-reported outcome measures (PROs) of cognition and quality of life via REDCap. Participants are randomized to MAAT or ST and assigned treating clinicians at respective cancer centers. All 8 visits are completed through secure telehealth platforms, followed by repeat phone/online assessment post-treatment and again at 6 months. Enrollment began 3/2021. As of 12/12/2023 (33.5 months), 116 participants are enrolled (58% of the planned sample), 116 randomized (MAAT 58; ST 58), with 81 completing post-treatment assessments. If all assessments and treatment visits were in person, travel burden per participant is 977 miles/22 hours driven, and $640 (US 2023 Federal rate). Thus, study travel savings to date are $74,240. Participant feedback indicates telehealth makes participation possible, similar to previous MAAT research. The current RCT demonstrates utility, efficiency and cost-savings of telehealth and remote data capture technology in the conduct of cancer control research. Methods described here can also be adopted for cancer therapeutic trials. Comprehensive cancer centers, where most clinical trials are based, can enhance participation of remote and/or underserved populations that have higher rates of cancer, more disease burden and less opportunity for trial participation. Clinical trial information: NCT04586530 .