Grant Number:	5R01CA263714-02 Interpret this number
Primary Investigator:	Badger, Terry
Organization:	University Of Arizona
Project Title:	Adaptive Symptom Self-Management to Reduce Psychological Distress and Improve Symptom Management for Survivors on Immune Checkpoint Inhibitors
Fiscal Year:	2023

The use of immune checkpoint inhibitors (ICIs), alone or in combination with other cancer treatments is increasing dramatically with immune-related adverse events (irAEs) common (90%) during ICI treatment. Most irAEs are symptomatic and symptom self-management with timely reporting of moderate or severe symptoms to HCPs may reduce irAE severity by early recognition and management, resulting in fewer treatment interruptions and unscheduled health services. Using a sequential multiple assignment randomized trial (SMART) design, we will initially randomize 286 diverse survivors (30% Hispanic) who are within 12 weeks of starting ICIs and who also have elevated psychological distress to an Automated Telephone Symptom Management (ATSM) or to an active control condition. ATSM consists of weekly telephone symptom monitoring using the PRO-CTCAE items by an automated voice response technology. Participants are referred to a printed Handbook with information about symptoms, evidence-based self-management strategies, and when to report symptoms to HCPs. ATSM automatically sends a weekly symptom summary to HCPs. Active control survivors will receive automated symptom monitoring only with reports sent to HCPs. Survivors in ATSM whose psychological distress is still elevated for 2 consecutive weeks during weeks 2-8 (non- responders) will be randomized for the second time to add TIPC for 8 weeks or continue with ATSM alone. We hypothesize adding TIPC will improve self-efficacy for symptom self-management, including communication with HCPs and increase social support resulting in lower indices of psychological distress, other PRO-CTCAE symptoms, clinician-documented irAES (primary outcomes), and unscheduled health services use and ICI treatment interruptions (secondary outcomes). With total intervention time of 16 weeks, all survivors will be interviewed at baseline and week 17 post-intervention, and electronic health record data will be extracted for the participation period. Specific aims: Aim 1. Determine if primary and secondary outcomes over weeks 1-17 are lower (better) in the group created by the first randomization: the adaptive intervention that begins with ATSM with the need-based addition of TIPC vs. active control group. Aim 2. Among those not responding to ATSM on psychological distress during weeks 2-8 who enter the second randomization, determine: a) if primary and secondary outcomes over weeks 8-17 are lower (better) in TIPC+ATSM vs. ATSM alone group; b) the extent to which the effects of adding TIPC to ATSM on primary and secondary outcomes are mediated by increased social support, self-efficacy for symptom management and for communication with HCP. Aim 3. Explore which baseline characteristics of the survivor, cancer, and cancer treatment are associated with optimal primary and secondary outcomes resulting from three supportive care options: 1) symptom monitoring only with automated reports to HCPs (active control); 2) ATSM alone for 16 weeks; or 3) addition of 8 weeks of TIPC to ATSM if no response on psychological distress during weeks 2-8.





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