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A Randomized Controlled Trial of Emotion Regulation Therapy for Cancer Caregivers: A Mechanism-Targeted Approach to Addressing Caregiver Distress

Award Number: R01CA244185
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/01/2020
PERIOD OF PERFORMANCE END DATE: 05/31/2025

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A Randomized Controlled Trial of Emotion Regulation Therapy for Cancer Caregivers: A Mechanism-Targeted Approach to Addressing Caregiver Distress - PROJECT SUMMARY Informal caregivers (ICs) of patients with cancer, who play an increasingly crucial role in the healthcare system, are at significant risk for severe and persistent anxiety and depression, even higher than levels reported by the patients for whom they provide care. Cognitive behavioral therapy (CBT) has demonstrated robust efficacy for clinical anxiety and depression for individuals in the general population, but CBTs adapted for cancer ICs evidence comparatively unsatisfying outcomes. One possible explanation for this lackluster efficacy is that these CBTs do not comprehensively target the factors that typically comprise the distress commonly experienced by ICs, such as attentional rigidity and perseverative negative thinking (PNT; e.g., worry and rumination). Emotion Regulation Therapy (ERT) is a contemporary CBT intervention developed to deliberately target processes underlying the distress associated with caregiving. ERT has established efficacy and initial support for proposed mechanisms in a series of trials for chronic anxiety and depression and is a promising candidate intervention to address the mechanisms likely complicating the resolution of IC anxiety and depression. Predicated on ERT, we developed Emotion Regulation Therapy for Cancer Caregivers (ERT- C) and demonstrated feasibility, acceptability, and initial efficacy in reducing depression and anxiety symptoms, PNT and emotion regulation deficits, and improving the quality of life of patients for whom ICs enrolled in ERT-C provided care. In this application, we propose to more stringently evaluate the efficacy of ERT-C and elucidate hypothesized mechanisms underlying reductions in distress. Through a multi-site trial, we will randomize 200 ICs to 8 sessions each of ERT-C or traditional CBT to evaluate primary and secondary outcomes at baseline, post-treatment, and at 3-and 6-months follow-up. Patient outcomes will also be collected at baseline and 3-months follow-up. We predict that ERT-C will be associated with superior anxiety and depression reductions in ICs and QOL in patients, with advantages maintained six months following treatment. Secondarily, we predict that ERT will produce greater gains in adaptive emotion regulation capacity and that these skills will partially mediate reductions in depression and anxiety symptoms. We will additionally examine the relative change in salivary markers of stress (e.g., diurnal cortisol) and inflammation (i.e., soluble tumor necrosis factor-alpha receptor II, CRP, Interleukin 6) in ICs receiving ERT-C versus CBT and predict that ERT- C will result in greater reductions in cortisol dysregulation and systemic inflammation as compared to CBT, and these gains will be maintained at 6-months follow-up. Our results will advance the science of IC intervention research by addressing a critical gap in our field’s ability to powerfully, quickly and effectively address IC anxiety and depression.


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: 2026 ( Subtotal = -$24,895 )
2026	2024	SLOAN-KETTERING INSTITUTE FOR CANCER RESEARCH	1275 YORK AVE	NEW YORK	NY	10065	NEW YORK	USA	Cancer Cause and Prevention Research	000	5	11/20/2025	NON-COMPETING CONTINUATION	-$24,895
														Subtotal = -$24,895

Issue Date FY: 2025 ( Subtotal = $0 )
2025	2024	SLOAN-KETTERING INSTITUTE FOR CANCER RESEARCH	1275 YORK AVE	NEW YORK	NY	10065	NEW YORK	USA	Cancer Cause and Prevention Research	000	5	3/12/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2024 ( Subtotal = $577,094 )
2024	2024	SLOAN-KETTERING INSTITUTE FOR CANCER RESEARCH	1275 YORK AVE	NEW YORK	NY	10065	NEW YORK	USA	Cancer Cause and Prevention Research	001	5	8/21/2024	NON-COMPETING CONTINUATION	$0
2024	2024	SLOAN-KETTERING INSTITUTE FOR CANCER RESEARCH	1275 YORK AVENUE	NEW YORK	NY	10065	NEW YORK	USA	Cancer Cause and Prevention Research	000	5	5/16/2024	NON-COMPETING CONTINUATION	$577,094
														Subtotal = $577,094

Issue Date FY: 2023 ( Subtotal = $598,002 )
2023	2023	SLOAN-KETTERING INSTITUTE FOR CANCER RESEARCH	1275 YORK AVE	NEW YORK	NY	10065	NEW YORK	USA	Cancer Cause and Prevention Research	000	4	5/31/2023	NON-COMPETING CONTINUATION	$598,002
														Subtotal = $598,002

Issue Date FY: 2022 ( Subtotal = $610,099 )
2022	2022	SLOAN-KETTERING INSTITUTE FOR CANCER RESEARCH	1275 YORK AVE	NEW YORK	NY	10065	NEW YORK	USA	Cancer Cause and Prevention Research	001	3	8/31/2022	NON-COMPETING CONTINUATION	$12,207
2022	2022	SLOAN-KETTERING INSTITUTE FOR CANCER RESEARCH	1275 YORK AVE	NEW YORK	NY	10065	NEW YORK	USA	Cancer Cause and Prevention Research	000	3	4/27/2022	NON-COMPETING CONTINUATION	$597,892
														Subtotal = $610,099

Issue Date FY: 2021 ( Subtotal = $608,430 )
2021	2021	SLOAN-KETTERING INSTITUTE FOR CANCER RESEARCH	1275 YORK AVE	NEW YORK	NY	10065	NEW YORK	USA	Cancer Cause and Prevention Research	000	2	5/5/2021	NON-COMPETING CONTINUATION	$608,430
														Subtotal = $608,430

Issue Date FY: 2020 ( Subtotal = $666,063 )
2020	2020	SLOAN-KETTERING INSTITUTE FOR CANCER RESEARCH	1275 YORK AVE	NEW YORK	NY	10065	NEW YORK	USA	Cancer Cause and Prevention Research	001	1	9/15/2020	NEW	$0
2020	2020	SLOAN-KETTERING INSTITUTE FOR CANCER RESEARCH	1275 YORK AVE	NEW YORK	NY	10065	NEW YORK	USA	Cancer Cause and Prevention Research	000	1	8/31/2020	NEW	$666,063
														Subtotal = $666,063

Grand Total All Awards = $3,034,793

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A Randomized Controlled Trial of Emotion Regulation Therapy for Cancer Caregivers: A Mechanism-Targeted Approach to Addressing Caregiver Distress

Award Number: R01CA244185

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 09/01/2020

PERIOD OF PERFORMANCE END DATE: 05/31/2025

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