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Telehealth Oncofertility Care for Young Cancer Patients

El Centro, CA
Phase 3
Recruiting
Led By H. Irene Su, MD, MSCE
Research Sponsored by University of California, San Diego
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Ages 0 to 50 years if male
Ages 0 to 42 years if female
Must not have
Metastatic/Stage IV non-thyroid solid tumors, because of poor prognosis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks after oncology visit
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial will test an intervention to help young cancer patients get fertility treatment that aligns with their goals.

See full description
Who is the study for?
This trial is for young cancer patients, both newly diagnosed or with a relapse, who speak English or Spanish. Females aged 0-42 and males 0-50 receiving care at participating sites can join. It's not for those with non-melanoma skin cancer due to low infertility risk from treatment.Check my eligibility
What is being tested?
The study tests a multi-component intervention aimed at improving engagement in fertility-related care among young cancer survivors. The effectiveness of this telehealth oncofertility program will be evaluated by how well it helps patients align their fertility goals with their medical care.See study design
What are the potential side effects?
Since the intervention involves telehealth services and educational resources rather than medications, traditional side effects are not expected. However, participants may experience emotional or psychological impacts related to discussions about fertility.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a male aged 50 or younger.
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I am a female aged 42 or younger.
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My cancer is either newly diagnosed or has come back.
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Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My cancer is advanced and has spread from the original site.
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Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks after oncology visit
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks after oncology visit for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Decisional Conflict
Number of reproductive-aged female and male patients (aged 12 to 39 years) who engage in goal-concordant oncofertility care
Secondary study objectives
Number of female (aged 0 to 42 years) and male (aged 0 to 50 years) patients who engage in goal-concordant oncofertility care
Number of female patients (aged 0 to 42 years) who engage in goal-concordant oncofertility care
Number of male patients (aged 0 to 50 years) who engage in goal-concordant oncofertility care

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Multi-component oncofertility care interventionExperimental Treatment1 Intervention
Eligible cancer patients presenting to oncology clinical visits will receive care through the multi-component oncofertility care intervention.
Group II: Usual CareActive Control1 Intervention
Eligible cancer patients presenting to oncology clinical visits will receive usual care.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Multi-component oncofertility care intervention
2021
N/A
~90

Find a Location

Closest Location:Cancer Resource Center of the Desert· El Centro, CA

Who is running the clinical trial?

University of California, San DiegoLead Sponsor
1,214 Previous Clinical Trials
1,590,389 Total Patients Enrolled
1 Trials studying Fertility Preservation
40 Patients Enrolled for Fertility Preservation
City of Hope Medical CenterOTHER
613 Previous Clinical Trials
1,921,239 Total Patients Enrolled
Rady Children's Hospital, San DiegoOTHER
41 Previous Clinical Trials
11,456 Total Patients Enrolled
H. Irene Su, MD, MSCEPrincipal InvestigatorUniversity of California, San Diego
2 Previous Clinical Trials
111 Total Patients Enrolled

Media Library

Multi-component oncofertility care intervention Clinical Trial Eligibility Overview. Trial Name: NCT05443737 — Phase 3
Fertility Preservation Research Study Groups: Usual Care, Multi-component oncofertility care intervention
Fertility Preservation Clinical Trial 2023: Multi-component oncofertility care intervention Highlights & Side Effects. Trial Name: NCT05443737 — Phase 3
Multi-component oncofertility care intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT05443737 — Phase 3
~1212 spots leftby Aug 2027
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