Evaluation of a Telehealth Oncofertility Care Intervention in Adolescent and Young Adult Cancer Patients

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Cancer, Fertility Preservation

Intervention / Treatment
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* Behavioral: Multi-component oncofertility care intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Newly diagnosed cancer or cancer relapse Primary language English or Spanish Receiving oncology care at participating clinical sites Ages 0 to 42 years if female Ages 0 to 50 years if male Exclusion Criteria: Non-melanoma skin cancer, because primary treatment is excision with no infertility risk Metastatic/Stage IV non-thyroid solid tumors, because of poor prognosis

Ages Eligible for Study
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Minimum Age: 0 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Stepped wedge cluster randomized controlled trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Multi-component oncofertility care intervention<br>Eligible cancer patients presenting to oncology clinical visits will receive care through the multi-component oncofertility care intervention. | Behavioral: Multi-component oncofertility care intervention<br>* 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.<br>|
| No Intervention: Usual Care<br>Eligible cancer patients presenting to oncology clinical visits will receive usual care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oncofertility, Fertility preservation, Adolescent and young adult cancer