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Remote Monitoring of Management of Chemotherapy induced Peripheral Neuropathy

Award Number: R01CA247517
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 05/06/2021
PERIOD OF PERFORMANCE END DATE: 04/30/2027

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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 health care costs. Symptoms are under reported, under treated 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 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 doctors visits are infrequent remains unexplored. The proposed 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 Aim1: 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 reduced opiate use measured by % of subjects on ≥ 50 MME/ day (high risk) and improve CIPN therapy utilization including neuropathic pain med 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.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = $372,282 )
2026	2026	UNIVERSITY OF VERMONT & STATE AGRICULTURAL COLLEGE	85 S PROSPECT STREET	BURLINGTON	VT	05405	CHITTENDEN	USA	Cancer Treatment Research	000	6	7/8/2026	NON-COMPETING CONTINUATION	$372,282
														Subtotal = $372,282

Issue Date FY: 2025 ( Subtotal = $1,393,948 )
2025	2025	UNIVERSITY OF VERMONT & STATE AGRICULTURAL COLLEGE	85 S PROSPECT STREET	BURLINGTON	VT	05405	CHITTENDEN	USA	Cancer Treatment Research	001	5	5/22/2025	NON-COMPETING CONTINUATION	$139,394
2025	2025	UNIVERSITY OF VERMONT & STATE AGRICULTURAL COLLEGE	85 S PROSPECT STREET	BURLINGTON	VT	05405	CHITTENDEN	USA	Cancer Treatment Research	000	5	5/6/2025	NON-COMPETING CONTINUATION	$1,254,554
														Subtotal = $1,393,948

Issue Date FY: 2024 ( Subtotal = $1,540,842 )
2024	2024	UNIVERSITY OF VERMONT & STATE AGRICULTURAL COLLEGE	85 S PROSPECT STREET	BURLINGTON	VT	05405	CHITTENDEN	USA	Cancer Treatment Research	000	4	6/24/2024	NON-COMPETING CONTINUATION	$1,540,842
														Subtotal = $1,540,842

Issue Date FY: 2023 ( Subtotal = $500,636 )
2023	2023	UNIVERSITY OF VERMONT & STATE AGRICULTURAL COLLEGE	85 S PROSPECT STREET	BURLINGTON	VT	05405	CHITTENDEN	USA	Cancer Treatment Research	000	3	8/25/2023	NON-COMPETING CONTINUATION	$500,636
														Subtotal = $500,636

Issue Date FY: 2022 ( Subtotal = $1,526,391 )
2022	2022	UNIVERSITY OF VERMONT & STATE AGRICULTURAL COLLEGE	85 S PROSPECT ST	BURLINGTON	VT	05405	CHITTENDEN	USA	Cancer Treatment Research	000	2	7/1/2022	NON-COMPETING CONTINUATION	$1,526,391
														Subtotal = $1,526,391

Issue Date FY: 2021 ( Subtotal = $1,170,573 )
2021	2021	UNIVERSITY OF VERMONT & STATE AGRICULTURAL COLLEGE	85 S PROSPECT ST	BURLINGTON	VT	05405	CHITTENDEN	USA	Cancer Treatment Research	000	1	5/6/2021	NEW	$1,170,573
														Subtotal = $1,170,573

Grand Total All Awards = $6,504,672

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Remote Monitoring of Management of Chemotherapy induced Peripheral Neuropathy

Award Number: R01CA247517

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 05/06/2021

PERIOD OF PERFORMANCE END DATE: 04/30/2027

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