R01CA247517

Remote Monitoring of Management of Chemotherapy Induced Peripheral Neuropathy

Chemotherapy Induced Peripheral Neuropathy (CIPN) is a common and disabling side effect of chemotherapy. It frequently leads to chemotherapy dose alteration, pain, fall risk, and increased healthcare costs. Symptoms are underreported, undertreated, and treatment often deviates from guidelines despite the opiate crisis. There is an urgent need for implementation of effective evidence and consensus-driven CIPN management.

Studies pairing a chemotherapy-related symptom reporting tool with nurse follow-up improved 6-month health-related quality of life and cancer survival. During chemotherapy, our studies pairing a CIPN symptom reporting tool with a Nurse Practitioner (NP) call back resulted in a 75% reduction in CIPN symptoms (this care model is called Symptom Care at Home with NP follow-up, SCH-NP). The efficacy of this system post-chemotherapy when CIPN symptoms are worst and doctor's visits are infrequent remains unexplored.

The proposed randomized controlled trial (RCT) will examine SCH-NP treatment during the period of maximal symptoms, utilize a standardized guideline-based care protocol, allow for phone, app, and web-based symptom reporting, and determine efficacy using neuropathy-specific outcomes. The overall goal of this study is to demonstrate the efficacy of a new care model that facilitates symptom reporting and proactive treatment management to reduce CIPN symptoms.

Specific Aim 1: Determine the efficacy of SCH-NP vs. usual care (UC) to reduce post-chemotherapy CIPN symptoms over 12 weeks. We hypothesize SCH-NP will reduce CIPN symptoms measured on the Neuropathy Total Symptom Score 6 (NTSS6). 358 recently diagnosed CIPN patients will be randomized to 12 weeks of UC or SCH-NP care. Both groups will report symptoms daily via phone, app, or website. The UC group will receive standard care through their treating physicians. In the SCH-NP group, reporting moderate to severe symptoms will trigger NP call back to provide evidence-based protocolized treatment including medications, self-care strategies, and referrals. Repeated measure analysis of the NTSS6 covariance will be used to compare groups.

Specific Aim 2: Determine the efficacy of SCH-NP vs. UC in improving CIPN-specific quality of life and disability. We hypothesize that compared to UC, SCH-NP care will improve CIPN-specific quality of life (EORTC CIPN 20) and reduce disability (CIPN-RODS) measured by repeated covariance analysis.

Specific Aim 3: Determine the impact of SCH-NP vs. UC on opiate usage and the utilization of available CIPN therapies. We hypothesize SCH-NP care will reduce opiate use measured by % of subjects on ≥ 50 MME/day (high risk) and improve CIPN therapy utilization including neuropathic pain medication use, time to prescription, selection of the correct therapy, adequate titration, max drug doses, and total number of CIPN treatments.

This innovative study utilizes a novel technology-based model to circumnavigate roadblocks in CIPN care. The study's broad impact and substantial significance derive from the model's ability to deliver care to those in resource-poor areas with reduced healthcare access in their time of greatest need.

University Of Vermont & State Agricultural College

TO DEVELOP THE MEANS TO CURE AS MANY CANCER PATIENTS AS POSSIBLE AND TO CONTROL THE DISEASE IN THOSE PATIENTS WHO ARE NOT CURED. CANCER TREATMENT RESEARCH INCLUDES THE DEVELOPMENT AND EVALUATION OF IMPROVED METHODS OF CANCER TREATMENT THROUGH THE SUPPORT AND PERFORMANCE OF BOTH FUNDAMENTAL AND APPLIED LABORATORY AND CLINICAL RESEARCH. RESEARCH IS SUPPORTED IN THE DISCOVERY, DEVELOPMENT, AND CLINICAL TESTING OF ALL MODES OF THERAPY INCLUDING: SURGERY, RADIOTHERAPY, CHEMOTHERAPY, AND BIOLOGICAL THERAPY INCLUDING MOLECULARLY TARGETED THERAPIES, BOTH INDIVIDUALLY AND IN COMBINATION. IN ADDITION, RESEARCH IS CARRIED OUT IN AREAS OF NUTRITIONAL SUPPORT, STEM CELL AND BONE MARROW TRANSPLANTATION, IMAGE GUIDED THERAPIES AND STUDIES TO REDUCE TOXICITY OF CYTOTOXIC THERAPIES, AND OTHER METHODS OF SUPPORTIVE CARE THAT MAY SUPPLEMENT AND ENHANCE PRIMARY TREATMENT. SMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAM: TO EXPAND AND IMPROVE THE SBIR PROGRAM, TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT, TO INCREASE SMALL BUSINESS PARTICIPATION IN FEDERAL RESEARCH AND DEVELOPMENT, AND TO FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN TECHNOLOGICAL INNOVATION. SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PROGRAM: TO STIMULATE AND FOSTER SCIENTIFIC AND TECHNOLOGICAL INNOVATION THROUGH COOPERATIVE RESEARCH AND DEVELOPMENT CARRIED OUT BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO FOSTER TECHNOLOGY TRANSFER BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT, AND TO FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN TECHNOLOGICAL INNOVATION.

93.395 - Cancer Treatment Research

National Cancer Institute (NCI) [HHS - NIH]

Burlington, Vermont 054050001 United States

Single Zip Code

Cancer Prevention and Control Clinical Trials Grant Program (R01 Clinical Trial Required) (PAR-18-559)

Amendment Since initial award the End Date has been extended from 04/30/26 to 04/30/27 and the total obligations have increased 424% from $1,170,573 to $6,132,390.