Grant Details
Grant Number: |
1R01CA271104-01A1 Interpret this number |
Primary Investigator: |
Su, Hui-Chun |
Organization: |
University Of California, San Diego |
Project Title: |
Evaluation of a Telehealth Oncofertility Care Intervention in Adolescent and Young Adult Cancer Patients: a Stepped Wedge Cluster Randomized Controlled Trial |
Fiscal Year: |
2023 |
Abstract
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.
Publications
Let's TOC Fertility: A stepped wedge cluster randomized controlled trial of the Telehealth Oncofertility Care (TOC) intervention in children, adolescent and young adult cancer survivors.
Authors: Romero S.A.D.
, Au L.
, Flores-Ortega R.E.
, Helsten T.
, Palomino H.
, Kaiser B.N.
, Echevarria M.
, Lukas K.
, Freeman K.
, Zou J.
, et al.
.
Source: Contemporary Clinical Trials, 2024 Jun; 141, p. 107537.
EPub date: 2024-04-13 00:00:00.0.
PMID: 38614445
Related Citations
Fertility preservation before and after cancer treatment in children, adolescents, and young adults.
Authors: Yang E.H.
, Strohl H.B.
, Su H.I.
.
Source: Cancer, 2023-11-14 00:00:00.0; , .
EPub date: 2023-11-14 00:00:00.0.
PMID: 37962199
Related Citations
Development, Usability Testing, and Implementation Assessment of Cancer Related Infertility Score Predictor, an Online Cancer Related Infertility Risk Counseling Tool.
Authors: Nerb L.
, Yang E.
, Exume D.
, Dornisch A.
, Zhou B.
, Helsten T.
, Kaiser B.N.
, Romero S.A.D.
, Su H.I.
.
Source: Journal Of Adolescent And Young Adult Oncology, 2023-05-12 00:00:00.0; , .
EPub date: 2023-05-12 00:00:00.0.
PMID: 37184539
Related Citations