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A value affirmation intervention for physical symptoms and medication adherence in breast cancer patients taking aromatase inhibitors

Award Number: R01CA236860
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 12/01/2019
PERIOD OF PERFORMANCE END DATE: 11/30/2025

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A value affirmation intervention for physical symptoms and medication adherence in breast cancer patients taking aromatase inhibitors - PROJECT SUMMARY/ABSTRACT The broad aim of this research is to evaluate whether a brief and cost-effective value affirmation writing intervention reduces physical symptoms, stress and medication non-adherence among breast cancer patients taking aromatase inhibitors (AIs). The majority of postmenopausal women diagnosed with breast cancer will be prescribed an AI; and while effective, these medications lead to toxic physical symptom side effect profiles and poor adherence. Interventions that target these side effects and the stress they cause may lead to improved medication adherence and therefore improved survival rates for breast cancer patients taking AIs. In pilot work from our group and others, thinking or writing about important personal values in value affirmation interventions have been linked to fewer physical symptoms, decreased stress, and improved medication adherence. While promising, these initial studies had small samples or were cross sectional in nature, and did not evaluate potential neurobiological mechanisms for intervention effects. The proposed study will be a randomized controlled trial (RCT) comparing a 6-month, portable value affirmation writing intervention (N=125) to a control writing intervention (N=125) in breast cancer patients taking aromatase inhibitors. Participants will complete self-reported measures of physical symptoms, adherence and stress at baseline, post-intervention, and 6-month follow-up. Medication adherence will also be assessed via electronic pill bottle reporting and refill latency during the study period. As an exploratory mechanistic aim, a subsample of AI patients from the parent RCT (N=120, 60 per intervention arm) will complete their mid-intervention value affirmation or control writing task while undergoing functional MRI. Thus, the proposed study will test two specific aims and an exploratory aim to determine: if value affirmation writing reduces physical symptoms and stress (Aim 1), improves medication adherence (Aim 2), and if neural reward activation during value affirmation is a neurobiological mechanism for these benefits (Exploratory Aim 1). The proposed RCT has the potential to identify a powerful, cost-effective, and easy-to-implement value affirmation intervention for reducing symptoms, stress, and medication non-adherence in breast cancer patients taking AIs.


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: 2025 ( Subtotal = $480,997 )
2025	2025	CARNEGIE MELLON UNIVERSITY	5000 FORBES AVE	PITTSBURGH	PA	15213	ALLEGHENY	USA	Cancer Cause and Prevention Research	000	5	5/7/2025	NON-COMPETING CONTINUATION	$480,997
														Subtotal = $480,997

Issue Date FY: 2024 ( Subtotal = $0 )
2024	2023	CARNEGIE MELLON UNIVERSITY	5000 FORBES AVE	PITTSBURGH	PA	15213	ALLEGHENY	USA	Cancer Cause and Prevention Research	000	4	2/2/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2023 ( Subtotal = $531,272 )
2023	2023	CARNEGIE MELLON UNIVERSITY	5000 FORBES AVE	PITTSBURGH	PA	15213	ALLEGHENY	USA	Cancer Cause and Prevention Research	000	4	12/21/2022	NON-COMPETING CONTINUATION	$487,904
2023	2023	CARNEGIE MELLON UNIVERSITY	5000 FORBES AVE	PITTSBURGH	PA	15213	ALLEGHENY	USA	Cancer Cause and Prevention Research	001	4	3/16/2023	NON-COMPETING CONTINUATION	$43,368
														Subtotal = $531,272

Issue Date FY: 2022 ( Subtotal = $531,267 )
2022	2022	CARNEGIE MELLON UNIVERSITY	5000 FORBES AVE	PITTSBURGH	PA	15213	ALLEGHENY	USA	Cancer Cause and Prevention Research	001	3	5/24/2022	NON-COMPETING CONTINUATION	$43,368
2022	2022	CARNEGIE MELLON UNIVERSITY	5000 FORBES AVE	PITTSBURGH	PA	15213	ALLEGHENY	USA	Cancer Cause and Prevention Research	000	3	12/7/2021	NON-COMPETING CONTINUATION	$487,899
														Subtotal = $531,267

Issue Date FY: 2021 ( Subtotal = $554,453 )
2021	2021	CARNEGIE MELLON UNIVERSITY	5000 FORBES AVE	PITTSBURGH	PA	15213	ALLEGHENY	USA	Cancer Cause and Prevention Research	000	2	12/1/2020	NON-COMPETING CONTINUATION	$526,730
2021	2021	CARNEGIE MELLON UNIVERSITY	5000 FORBES AVE	PITTSBURGH	PA	15213	ALLEGHENY	USA	Cancer Cause and Prevention Research	001	2	2/12/2021	NON-COMPETING CONTINUATION	$27,723
														Subtotal = $554,453

Issue Date FY: 2020 ( Subtotal = $578,139 )
2020	2020	CARNEGIE MELLON UNIVERSITY	5000 FORBES AVE	PITTSBURGH	PA	15213	ALLEGHENY	USA	Cancer Cause and Prevention Research	001	1	1/23/2020	NEW	$13,624
2020	2020	CARNEGIE MELLON UNIVERSITY	5000 FORBES AVE	PITTSBURGH	PA	15213	ALLEGHENY	USA	Cancer Cause and Prevention Research	000	1	11/28/2019	NEW	$564,515
														Subtotal = $578,139

Grand Total All Awards = $2,676,128

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A value affirmation intervention for physical symptoms and medication adherence in breast cancer patients taking aromatase inhibitors

Award Number: R01CA236860

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 12/01/2019

PERIOD OF PERFORMANCE END DATE: 11/30/2025

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