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Improving Informal Caregivers' and Cancer Survivors' Psychological Distress, Symptom Management and Health Care Use

Award Number: R01CA224282
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 07/06/2018
PERIOD OF PERFORMANCE END DATE: 06/30/2023

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Improving Informal Caregivers' and Cancer Survivors' Psychological Distress, Symptom Management and Health Care Use - 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.


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: 2024 ( Subtotal = -$9 )
2024	2021	UNIVERSITY OF ARIZONA	845 N PARK AVE RM 538	TUCSON	AZ	85721	PIMA	USA	Cancer Cause and Prevention Research	000	4	1/11/2024	NON-COMPETING CONTINUATION	-$9
														Subtotal = -$9

Issue Date FY: 2021 ( Subtotal = $610,291 )
2021	2021	UNIVERSITY OF ARIZONA	888 N EUCLID AVE RM 510	TUCSON	AZ	85719	PIMA	USA	Cancer Cause and Prevention Research	000	4	6/17/2021	NON-COMPETING CONTINUATION	$610,291
														Subtotal = $610,291

Issue Date FY: 2020 ( Subtotal = $738,166 )
2020	2020	UNIVERSITY OF ARIZONA	888 N EUCLID AVE RM 510	TUCSON	AZ	85719	PIMA	USA	Cancer Cause and Prevention Research	001	3	7/27/2020	NON-COMPETING CONTINUATION	$124,196
2020	2020	UNIVERSITY OF ARIZONA	888 N EUCLID AVE RM 510	TUCSON	AZ	85719	PIMA	USA	Cancer Cause and Prevention Research	000	3	5/29/2020	NON-COMPETING CONTINUATION	$613,970
														Subtotal = $738,166

Issue Date FY: 2019 ( Subtotal = $685,739 )
2019	2019	UNIVERSITY OF ARIZONA	888 N EUCLID AVE RM 510	TUCSON	AZ	85719	PIMA	USA	Cancer Cause and Prevention Research	000	2	6/26/2019	NON-COMPETING CONTINUATION	$618,141
2019	2019	UNIVERSITY OF ARIZONA	888 N EUCLID AVE RM 510	TUCSON	AZ	85719	PIMA	USA	Cancer Cause and Prevention Research	001	2	8/8/2019	NON-COMPETING CONTINUATION	$67,598
														Subtotal = $685,739

Issue Date FY: 2018 ( Subtotal = $650,204 )
2018	2018	UNIVERSITY OF ARIZONA	888 N EUCLID AVE RM 510	TUCSON	AZ	85719	PIMA	USA	Cancer Cause and Prevention Research	000	1	7/6/2018	NEW	$650,204
														Subtotal = $650,204

Grand Total All Awards = $2,684,391

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Improving Informal Caregivers' and Cancer Survivors' Psychological Distress, Symptom Management and Health Care Use

Award Number: R01CA224282

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 07/06/2018

PERIOD OF PERFORMANCE END DATE: 06/30/2023

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