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Evaluation of a telehealth oncofertility care intervention in adolescent and young adult cancer patients: a stepped wedge cluster randomized controlled trial

Award Number: R01CA271104
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 12/01/2022
PERIOD OF PERFORMANCE END DATE: 11/30/2027

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Evaluation of a telehealth oncofertility care intervention in adolescent and young adult cancer patients: a stepped wedge cluster randomized controlled trial - One of every 20 new cancer cases is diagnosed in an adolescent or young adult (AYA) aged 12–39 years. Both female and male AYA cancer patients experience increase risks of infertility and gonadal failure, devastating late effects which are preventable through effective fertility preservation (FP) services prior to cancer treatment. At the intersection of oncology and fertility, oncofertility care is the evidence-based practice of discussing reproductive risks with newly diagnosed cancer patients and supporting shared decision-making on FP services. Despite longstanding clinical guidelines, oncofertility care uptake is low because we currently lack scalable interventions to support its implementation in adult and pediatric cancer care settings. Drawing on implementation science, our transdisciplinary team conducted systematic environmental scans across 10 diverse health systems which corroborated prior research on barriers to care and led to the development, usability testing, pilot testing and tailoring of the multi-component telehealth oncofertility care (TOC) intervention. Intervention components are: 1) EHR-based oncofertility needs screen and referral pathway to a virtual oncofertility hub; 2) telehealth oncofertility counseling through the hub; and 3) telehealth oncofertility financial navigation through the hub. The proposed TOC trial is a stepped wedge cluster randomized trial of 18 adult and pediatric oncology clinics across three health systems. We will test the hypotheses that the intervention condition will be associated with increased proportion of patients who engage in goal-concordant oncofertility care (i.e., engagement in reproductive risk counseling and fertility preservation services that meet the patient’s fertility goals) (Aim 1) and improved patient-reported outcomes and achievement of patient-centered goals (Aim 2), compared to the usual care control condition. To decrease the time lag from research discovery to clinical care, we will evaluate intervention implementation using mixed methods guided by implementation science frameworks (Aim 3). The TOC intervention is innovative for its multi-level approach, medical financial hardship target, hub and spoke model bridging a virtual oncofertility hub with multi-institutional oncology clinics, and focus on contextual fit that enables implementation across separate EHR instances and in both adult and pediatric settings. The proposal is innovative in taking an implementation science-informed approach that considers policy, organizational context, and patient preference to evaluate effectiveness and implementation for future scale-up. IMPACT: Responsive to Congress’ Childhood Cancer Survivorship, Treatment, Access and Research (STAR) Act of 2018 and NCI’s NOSIs on use of telehealth in cancer-related care (NOT-CA-21-043) and addressing cancer-related financial hardship (NOT-CA-22-045), this proposal has the potential for high clinical impact through reducing significant inequities in access to oncofertility care and enabling AYA cancer patients to engage in care that preserves their reproductive futures and improves life after cancer.


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 = $621,487 )
2025	2025	UNIVERSITY OF CALIFORNIA, SAN DIEGO	9500 GILMAN DR	LA JOLLA	CA	92093	SAN DIEGO	USA	Cancer Cause and Prevention Research	001	3	5/29/2025	NON-COMPETING CONTINUATION	$62,149
2025	2025	UNIVERSITY OF CALIFORNIA, SAN DIEGO	9500 GILMAN DR	LA JOLLA	CA	92093	SAN DIEGO	USA	Cancer Cause and Prevention Research	000	3	11/15/2024	NON-COMPETING CONTINUATION	$559,338
														Subtotal = $621,487

Issue Date FY: 2024 ( Subtotal = $590,153 )
2024	2024	UNIVERSITY OF CALIFORNIA, SAN DIEGO	9500 GILMAN DR	LA JOLLA	CA	92093	SAN DIEGO	USA	Cancer Cause and Prevention Research	001	2	4/17/2024	NON-COMPETING CONTINUATION	$31,063
2024	2024	UNIVERSITY OF CALIFORNIA, SAN DIEGO	9500 GILMAN DRIVE	LA JOLLA	CA	92093	SAN DIEGO	USA	Cancer Cause and Prevention Research	000	2	11/16/2023	NON-COMPETING CONTINUATION	$559,090
														Subtotal = $590,153

Issue Date FY: 2023 ( Subtotal = $632,351 )
2023	2023	UNIVERSITY OF CALIFORNIA, SAN DIEGO	9500 GILMAN DR	LA JOLLA	CA	92093	SAN DIEGO	USA	Cancer Cause and Prevention Research	000	1	12/1/2022	NEW	$632,351
														Subtotal = $632,351

Grand Total All Awards = $1,843,991

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Evaluation of a telehealth oncofertility care intervention in adolescent and young adult cancer patients: a stepped wedge cluster randomized controlled trial

Award Number: R01CA271104

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 12/01/2022

PERIOD OF PERFORMANCE END DATE: 11/30/2027

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