Grant Number:	5R01CA224282-04 Interpret this number
Primary Investigator:	Badger, Terry
Organization:	University Of Arizona
Project Title:	Improving Informal Caregivers' and Cancer Survivors' Psychological Distress, Symptom Management and Health Care Use
Fiscal Year:	2021

Informal caregivers, typically family members or friends, provide more than half of the care needed for the 5.7 million cancer survivors in the United States, often with negative health consequences. At least 30% of survivors and their caregivers report psychological distress (depression and anxiety) and such distress may interfere with optimal symptom management. This study will support both members of the survivor-caregiver dyad in the management of the survivor's cancer- and treatment-related symptoms and the dyad's psychological distress. Design: We will use the sequential multiple assignment randomized trial (SMART) design, a newer adaptive design. The SMART moves beyond a traditional RCT to a precision approach to determine the right treatment at the right dose with the right sequence for the right survivor-caregiver dyad. We will use two evidence-based interventions: Symptom Management Toolkit (SMT) and Telephone Interpersonal Counseling (TIP-C). While we have established the overall efficacy of these interventions, but individuals differ in responses. When an intervention does not initially work, clinic logic is to either extend the timeframe or prescribe a different intervention. Yet, such alternatives are seldom tested nor evidence-based. However, they will be in this study. Sample: We will enroll 298 survivors with elevated depression or anxiety who are undergoing chemotherapy or targeted therapy for a solid tumor and their 298 caregivers. Procedure: Dyads will be initially randomized to SMT alone or TIP-C +SMT. If the survivor's elevated depression or anxiety does not respond to SMT alone by week 4, dyads will be re-randomized to continue with SMT to give it more time or to TIP-C+SMT. Outcome data will be collected at baseline, weeks 13 (post-intervention) and 17 (follow-up). Assessments during weeks 1-12 will document changes in symptoms, intervention receipt, enactment and fidelity. Specific aims: 1) Determine if dyads in the TIP-C+SMT as compared to the SMT alone group created by the first randomization will have: a) lower depression, anxiety, and summed severity of 13 other symptoms at weeks 1-12, 13, and 17 (primary outcomes); b) lower use of healthcare services (hospitalizations, urgent care or emergency department [ED] visits) during 17 weeks (secondary outcomes); c) greater self-efficacy, social support, and lower caregiver burden during weeks 13 and 17 (potential mediators). 2) Among non- responders to the SMT alone after 4 weeks, determine if dyads assigned to TIP-C+SMT as compared to the SMT alone group created by the second randomization will have better primary and secondary outcomes and potential mediators at weeks 5-12, 13, and 17. 3) Test the interdependence in survivor's and caregiver's primary and secondary outcomes. 4) Determine which characteristics of the dyad are associated with responses to the SMT alone during weeks 1-4 and optimal outcomes for the dyad during weeks 1-12, 13 and 17 so as to determine tailoring variables for the decision rules of individualized sequencing of interventions. Findings will be used to improve symptom management and reduce distress in survivor-caregiver dyads.





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