Grant Number:	1R01CA279472-01 Interpret this number
Primary Investigator:	Sikorskii, Alla
Organization:	Michigan State University
Project Title:	Managing Symptoms and Psychological Distress During Oral Anti-Cancer Treatment
Fiscal Year:	2023

In exchange for eliminating repeated and extended time in infusion units, cancer survivors (people from the diagnosis to end of life) on oral anti-cancer agents must self-manage their symptoms (e.g., fatigue, depression, skin rash). In this hybrid type 1 effectiveness implementation trial, we test an adaptive symptom management intervention delivered in English or Spanish. It consists of the 12-week Automated Telephone Symptom Management (ATSM) to address common cancer- and treatment-related symptoms and the 8-week Telephone Interpersonal Counseling (TIPC) to address psychological distress. The ATSM consists of weekly monitoring of symptoms using the Patient Reported Outcomes Common Terminology Criteria for Adverse Events (PRO- CTCAE) via highly accessible telephone-based interactive voice response (IVR), with summary IVR reports sent to oncology providers and direction to use a printed Handbook for elevated symptoms. When self- management is not sufficient to reduce depression or anxiety, the 8-week TIPC delivered by social workers via telehealth is added to the ATSM. The concept for this project has been approved by NRG Oncology’s National Community Oncology Research Program (NCORP). Twelve NCORP sites will be randomized in 1:1 ratio to the 12-week adaptive ATSM+TIPC or active control of IVR symptom monitoring with reports to clinicians (no Handbook, no TIPC), with 516 survivors on oral anti-cancer treatment nested within sites. The specific aims are to: 1. Test the effectiveness of ATSM+TIPC versus active control with respect to survivor-level outcomes of: a) The summary toxicity index of 24 PRO-CTCAE symptoms (primary) that include depressive, anxiety, and other symptoms commonly experienced during oral anti-cancer treatment over weeks 1-12 (immediate effect) and 13-17 (sustained effect); b) Unscheduled health services use (secondary) over weeks 1-12 and 13-17. We hypothesize that primary and secondary outcomes will be better (lower) in the ATSM+TIPC than active control. 2. Evaluate implementation outcomes at the clinician level (physicians, nurses, social workers, other): a) Feasibility as reflected by clinicians’ time to address weekly IVR symptom reports. b) Clinician’s actions on symptom reports (symptom-related oncology visits, oral agent treatment alterations, prescriptions of supportive care medications, referrals to supportive care services). c) Treatment fidelity of TIPC delivered by social workers in the ATSM+TIPC arm and time spent by them. d) Clinician’s perceptions of intervention acceptability and appropriateness for the community oncology clinic. 3. Estimate delivery cost of the ATSM+TIPC and active control and cost savings for the ATSM+TIPC versus active control as a result of reduced unscheduled health services use. This trial will inform the implementation and dissemination of the ATSM+TIPC intervention in the community- based oncology settings to improve symptom management for survivors undergoing oral anti-cancer treatment.





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