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Telehealth Oncofertility Care for Young Cancer Patients

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks after oncology visit

Awards & highlights

Study Summary

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

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks after oncology visit

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Decisional Conflict

Number of reproductive-aged female and male patients (aged 12 to 39 years) who engage in goal-concordant oncofertility care

Secondary outcome measures

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

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.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of California, San DiegoLead Sponsor

1,121 Previous Clinical Trials

1,518,124 Total Patients Enrolled

1 Trials studying Fertility Preservation

40 Patients Enrolled for Fertility Preservation

City of Hope Medical CenterOTHER

567 Previous Clinical Trials

1,919,860 Total Patients Enrolled

Rady Children's Hospital, San DiegoOTHER

39 Previous Clinical Trials

10,733 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do elderly patients qualify for participation in this research?

"The target population for this study are those aged 0-50."

Answered by AI

Has the FDA cleared this cancer fertility care program?

"The safety of the oncofertility care intervention was estimated to be a 3."

Answered by AI

Are there any spots left for patients in this clinical trial?

"Yes, as of October 31st, 2022 this trial is still recruiting patients. The study was initial posted on January 1st, 20202 and is looking for 2800 participants from 3 clinical locations."

Answered by AI

How many people have been chosen to participate in this experiment?

"The clinical trial is currently recruiting patients, with the goal of enrolling 2800 individuals from 3 sites. The study was originally posted on 1/1/2022 and has been updated as recently as 10/31/2022 according to information found on clinicaltrials.gov"

Answered by AI

Might I be eligible to join this research project?

"This study, which is still recruiting patients, needs 2800 individuals that have malignancies and are between 0-50 years old. Other requirements for potential participants include: having newly diagnosed cancer or experiencing a cancer relapse, receiving oncology care at one of the participating clinical sites, being male (0-50 years old) or female (0-42 years old), and speaking either English or Spanish as their primary language."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Hui-Chun Irene Su 2022. "Evaluation of a Telehealth Oncofertility Care Intervention in Adolescent and Young Adult Cancer Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05443737.

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