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

Phase 3

Recruiting

• Conditions: Fertility Preservation; Cancer
• Interventions: Behavioral: Multi-component oncofertility care intervention

• Registration Number: NCT05443737
• Lead Sponsor: University of California, San Diego

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-01
• Study First Submitted: 2022-06-24
• Study First Submitted QC: 2022-06-29
• Study First Posted: 2022-07-05
• Status Verified: 2024-11
• Last Update Submitted: 2025-01-08
• Last Update Posted: 2025-01-10
• Primary Completion: 2027-08-31
• Study Completion: 2027-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2800

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Multi-component oncofertility care intervention	Multi-component oncofertility care intervention	Eligible cancer patients presenting to oncology clinical visits will receive care through the multi-component oncofertility care intervention.

Primary Outcome Measures

Name	Time	Method
Decisional Conflict	12 weeks after oncology visit	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).
Number of reproductive-aged female and male patients (aged 12 to 39 years) who engage in goal-concordant oncofertility care	12 weeks after oncology visit	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.

Secondary Outcome Measures

Name	Time	Method
Number of female (aged 0 to 42 years) and male (aged 0 to 50 years) patients who engage in goal-concordant oncofertility care	12 weeks after oncology visit	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.
Number of female patients (aged 0 to 42 years) who engage in goal-concordant oncofertility care	12 weeks after oncology visit	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.
Number of male patients (aged 0 to 50 years) who engage in goal-concordant oncofertility care	12 weeks after oncology visit	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.

Trial Locations

Locations (4)

City of Hope; 🇺🇸 Duarte, California, United States

Cancer Resource Center of the Desert; 🇺🇸 El Centro, California, United States

University of California San Diego; 🇺🇸 La Jolla, California, United States

Rady Children's Hospital San Diego; 🇺🇸 San Diego, California, United States