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| Name | Class |
|---|---|
| Rady Children's Hospital, San Diego | OTHER |
| City of Hope Medical Center | OTHER |
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The purpose of this study is to evaluate the effectiveness of a multi-component intervention to improve young cancer survivors' engagement in goal-concordant oncofertility care, concurrently with observing and gathering information on how the intervention is implemented. The investigators hypothesize that implementation of the intervention will result in increased young cancer survivors' engagement in goal-concordant oncofertility care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multi-component oncofertility care intervention | Experimental | Eligible cancer patients presenting to oncology clinical visits will receive care through the multi-component oncofertility care intervention. |
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| Usual Care | No Intervention | Eligible cancer patients presenting to oncology clinical visits will receive usual care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multi-component oncofertility care intervention | Behavioral | The multi-component oncofertility care intervention includes: (1) an adaptive and smart default electronic health record-based oncofertility needs screen and referral pathway, (2) telehealth oncofertility counseling as indicated, and (3) telehealth oncofertility financial navigation as indicated. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of reproductive-aged female and male patients (aged 12 to 39 years) who engage in goal-concordant oncofertility care | The proportion of eligible reproductive-aged male and female patients (aged 12 to 39 years) who engage in oncofertility services (1| an oncofertility needs screen, 2| referral to oncofertility consult, 3| oncofertility consult, and/or 4| fertility preservation services) that meet the patient's individual needs will be abstracted from medical records using standardized case report forms. | 12 weeks after oncology visit |
| Decisional Conflict | The 16-item Decisional Conflict Scale (DCS) will be used to measure patients' decisional conflict for engaging in fertility preservation services. The DCS consists of 16 statements with 5 response options (ranging from strongly agree to strongly disagree) that measures the patient's perceptions of uncertainty in choosing options, feeling informed, values clarity, support in decision making, and effective decision making. The DCS total score will be dichotomized at 37.5 (scale 0-100; > 37.5 indicates high decisional conflict). | 12 weeks after oncology visit |
| Measure | Description | Time Frame |
|---|---|---|
| Number of female (aged 0 to 42 years) and male (aged 0 to 50 years) patients who engage in goal-concordant oncofertility care | The proportion of eligible female and male patients (aged 0 to 42 years for females; 0 to 50 years for males) who engage in oncofertility services [1) an oncofertility needs screen, 2) referral to oncofertility consult, 3) oncofertility consult, and/or 4) fertility preservation services] that meet the patient's individual needs will be abstracted from medical records using standardized case report forms. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| H. Irene Su, MD, MSCE | Contact | 858-822-5986 | hisu@health.ucsd.edu | |
| Sally AD Romero, PhD, MPH | Contact | 858-822-1371 | saromero@health.ucsd.edu |
| Name | Affiliation | Role |
|---|---|---|
| H. Irene Su, MD, MSCE | University of California, San Diego | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope | Recruiting | Duarte | California | 91010-3000 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38614445 | Derived | Romero SAD, Au L, Flores-Ortega RE, Helsten T, Palomino H, Kaiser BN, Echevarria M, Lukas K, Freeman K, Zou J, Aristizabal P, Armenian S, Su HI. 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. Contemp Clin Trials. 2024 Jun;141:107537. doi: 10.1016/j.cct.2024.107537. Epub 2024 Apr 13. |
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Deidentified individual participant data generated during the study will be available from the principal investigator (H. Irene Su) upon reasonable request.
Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication.
Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to the principal investigator (H. Irene Su).
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Stepped wedge cluster randomized controlled trial
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Fertility specialists and their support staff will be blinded to the intervention status of the cluster from which a patient is referred to minimize differences in counseling in patients whom they expect to receive financial navigation.
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| 12 weeks after oncology visit |
| Number of female patients (aged 0 to 42 years) who engage in goal-concordant oncofertility care | The proportion of eligible female patients (aged 0 to 42 years) who engage in oncofertility services [1) an oncofertility needs screen, 2) referral to oncofertility consult, 3) oncofertility consult, and/or 4) fertility preservation services] that meet the patient's individual needs will be abstracted from medical records using standardized case report forms. | 12 weeks after oncology visit |
| Number of male patients (aged 0 to 50 years) who engage in goal-concordant oncofertility care | The proportion of eligible male patients (aged 0 to 50 years) who engage in oncofertility services [1) an oncofertility needs screen, 2) referral to oncofertility consult, 3) oncofertility consult, and/or 4) fertility preservation services] that meet the patient's individual needs will be abstracted from medical records using standardized case report forms. | 12 weeks after oncology visit |
| Cancer Resource Center of the Desert | Active, not recruiting | El Centro | California | 92243 | United States |
| University of California San Diego | Recruiting | La Jolla | California | 92093 | United States |
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| Rady Children's Hospital San Diego | Recruiting | San Diego | California | 92123 | United States |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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