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Principal Investigator: Terry A Badger
Organization: UNIVERSITY OF ARIZONA
Fiscal Year: 2024
Award: $613,316
Funding agency: National Cancer Institute
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.
Terms: <Address><Affect><Anxiety><CTCAE><Cancer Survivor><Cancer Treatment><Cancers><Characteristics><Checkpoint inhibitor><Cognitive><Common Terminology Criteria for Adverse Events><Common Toxicity Criteria><Communication><Counseling><Data><Diagnosis><Dose><E-Mail><ED visit><ER visit><Electronic Health Record><Electronic Mail><Email><Emergency care visit><Emergency department visit><Emergency hospital visit><Emergency room visit><Emotional><Espanol><Exanthem><Exanthema><Fatigue><Guidelines><HIPAA><Health Care Providers><Health Insurance Portability and Accountability Act><Health Personnel><Health Services><Healthcare Providers><Healthcare worker><Hematologic Cancer><Hematologic Malignancies><Hematologic Neoplasms><Hematological Malignancies><Hematological Neoplasms><Hematological Tumor><Hematopoietic Cancer><Hispanic><Hospital Admission><Hospitalization><Iatrogenic Cancer><Immune checkpoint inhibitor><Individual><Interruption><Intervention><Intervention Strategies><Interview><Kennedy Kassebaum Act><Lack of Energy><Lead><Link><Malignant Hematologic Neoplasm><Malignant Neoplasm Therapy><Malignant Neoplasm Treatment><Malignant Neoplasms><Malignant Tumor><Mediating><Mental Depression><Monitor><Oral><Organ><PL 104-191><PL104-191><Pain><Painful><Participant><Patient Outcomes Assessments><Patient Reported Measures><Patient Reported Outcomes><Patient Selection><Pb element><Phone><Population><Printing><Public Law 104-191><Randomized><Rash><Reporting><Research Resources><Resources><SYS-TX><Science><Self Efficacy><Self Management><Sentinel><Sequential Multiple Assignment Randomized Trial><Severities><Skin Rash><Social support><Solid><Spanish><Steroid Compound><Steroids><Supportive Therapy><Supportive care><Survivors><Symptoms><Systemic Therapy><Technology><Telephone><Testing><Therapy Related Malignant Neoplasm><Therapy Related Malignant Tumor><Therapy-Associated Cancers><Therapy-Related Cancer><Time><Treatment-Associated Cancer><Treatment-Related Cancer><United States Health Insurance Portability and Accountability Act><Voice><Work><active control><active control group><adaptive intervention><anti-cancer therapy><cancer therapy><cancer type><cancer-directed therapy><depression><design><designing><electronic communication><electronic health care record><electronic health medical record><electronic health plan record><electronic health registry><electronic medical health record><end of life><end-of-life><evidence base><experience><handbook><health care personnel><health care worker><health provider><health service use><health service utilization><health workforce><healthcare personnel><heavy metal Pb><heavy metal lead><immune check point inhibitor><immune-mediated adverse events><immune-related adverse effect><immune-related adverse events><immune-related adverse reaction><improve symptom><improved><indexing><interventional strategy><malignancy><manage symptom><medical personnel><neoplasm/cancer><post intervention><prevent><preventing><primary outcome><psychological distress><randomisation><randomization><randomly assigned><response><secondary outcome><sleep difficulty><social support network><success><symptom improvement><symptom management><symptom self management><symptomatic improvement><treatment guidelines><treatment provider><trial design>