Telehealth Oncofertility Care for Young Cancer Patients

Recruiting at 3 trial locations

Overseen By H. Irene Su, MD, MSCE

Age: < 65

Sex: Any

Trial Phase: Phase 3

Sponsor: University of California, San Diego

Disqualifiers: Non-melanoma skin cancer, Metastatic tumors

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

2800 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to help young cancer survivors manage fertility options after treatment. It examines whether a special, multi-part care program, the Multi-component Oncofertility Care Intervention, can enhance patient involvement in fertility planning aligned with their personal goals. Participants will receive either this new care or their usual care to determine which is more effective. Individuals who recently received a cancer diagnosis or experienced a relapse, speak English or Spanish, and receive oncology care at specific clinics may qualify. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking fertility care solution.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the oncofertility care program is safe for young cancer patients. Previous studies found that patients handled the telehealth-based care well, with no major negative effects reported. This indicates that the treatment is generally safe and accepted. As the study is in a late phase, extensive safety information is available. In other words, the treatment has undergone sufficient testing to ensure safety for most people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the multi-component oncofertility care intervention because it leverages telehealth to provide comprehensive reproductive health support to young cancer patients, which is not typically part of standard cancer care. Unlike traditional approaches that might involve separate, in-person visits to fertility specialists, this intervention integrates fertility preservation discussions and decision-making into regular oncology appointments via virtual consultations. This approach not only ensures timely and holistic fertility care but also makes it more accessible and convenient for patients, potentially increasing the likelihood of preserving fertility before starting cancer treatments.

What evidence suggests that this trial's multi-component oncofertility care intervention could be effective for young cancer patients?

Research shows that a special oncofertility care program, available to participants in this trial, can greatly enhance how young cancer patients engage with fertility care. This program uses telehealth to simplify access to information and services about preserving fertility. In past studies, participants were more likely to discuss fertility options with their doctors and follow care aligned with their goals. The program aims to fill gaps in fertility support by offering personalized and easily accessible guidance. Overall, early evidence suggests that this program could effectively boost involvement in fertility care for young cancer survivors. ^{1 3 6 7 8}

Who Is on the Research Team?

H. Irene Su, MD, MSCE

Principal Investigator

University of California, San Diego

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Primary language English or Spanish

I am a male aged 50 or younger.

Receiving oncology care at participating clinical sites

Exclusion Criteria

My cancer is advanced and has spread from the original site.

I have skin cancer that is not melanoma and it's treated by cutting it out.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Eligible cancer patients receive care through the multi-component oncofertility care intervention

12 weeks

Visits coincide with oncology clinical visits

Follow-up

Participants are monitored for engagement in goal-concordant oncofertility care and decisional conflict

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Multi-component oncofertility care intervention

Trial Overview

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.

How Is the Trial Designed?

Group I: Multi-component oncofertility care intervention Experimental Treatment 1 Intervention

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

Group II: Usual Care Active Control 1 Intervention

Eligible cancer patients presenting to oncology clinical visits will receive usual care.

Multi-component oncofertility care intervention is already approved in United States for the following indications:

Approved in United States as Oncofertility Care Intervention for:

• Oncofertility care for adolescent and young adult cancer patients

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+

City of Hope Medical Center

Collaborator

Trials

614

Recruited

1,924,000+

Rady Children's Hospital, San Diego

Collaborator

Trials

42

Recruited

14,300+

Published Research Related to This Trial

A cluster-randomised trial will evaluate a multicomponent intervention, including provider education and patient decision aids, to improve fertility preservation knowledge and decision-making among 100 newly diagnosed women of reproductive age at risk of cancer-related infertility.

The study aims to address the low rates of fertility consultations (only 5% currently) by providing structured support and information, potentially reducing long-term infertility-related distress.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pathways: patient-centred decision counselling for women at risk of cancer-related infertility: a protocol for a comparative effectiveness cluster randomised trial. Woodard, TL., Hoffman, AS., Crocker, LC., et al.[2020]

A survey of 81 fertility patients revealed that 81.4% were satisfied with telehealth for fertility care, highlighting its usefulness, ease of use, and effectiveness.

Despite high satisfaction with telehealth, 60.5% of patients preferred in-person visits for their initial consultation, suggesting that while telehealth is effective, many still value face-to-face interactions for starting their fertility journey.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient perspectives of telehealth for fertility care: a national survey. Lersten, I., Fought, A., Yannetsos, C., et al.[2023]

Fertility navigators play a crucial supportive role for female cancer patients undergoing fertility preservation, providing emotional support, information, and continuity of care, which enhances patient satisfaction.

Healthcare professionals also benefit from the presence of fertility navigators, as they help manage tasks and improve collaboration, suggesting that their consistent involvement in counseling could further enhance the care process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fertility navigators in female oncofertility care in an academic medical center: a qualitative evaluation. van den Berg, M., Nadesapillai, S., Braat, DDM., et al.[2021]

A systematic assessment of oncofertility care identified key barriers and facilitators within healthcare settings, leading to the development of five scalable strategies to improve care for cancer patients, particularly through electronic health record (EHR) tools.

The study involved 19 healthcare providers and 9 cancer survivors, and it highlighted the importance of integrating screening, referral, and fertility preservation counseling into oncology practices to enhance oncofertility care implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Theory-Guided Development of Fertility Care Implementation Strategies for Adolescent and Young Adult Cancer Survivors. Dornisch, A., Yang, EH., Gruspe, J., et al.[2023]

In a study of 67 young women undergoing oncofertility care, spontaneous pregnancies were more common than those achieved through assisted reproductive technology (ART), suggesting that non-ART methods are a viable option for young cancer survivors.

Breast cancer patients took longer to start oncofertility treatment compared to those with hematologic cancers, indicating a potential need for improved timelines in care for this group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oncofertility care in young women and the outcomes of pregnancy over the last 5 years. Takahashi, S., Horie, A., Yamamura, S., et al.[2022]

The pilot test of an EHR-enabled oncofertility intervention in an adult oncology program improved the screening of fertility needs from 30% to 51%, indicating increased awareness and implementation of oncofertility care.

Feedback from healthcare providers across various oncology settings highlighted the need for modifications to the intervention, suggesting that while it was effective, adaptations are necessary to enhance its fit and usability in different clinical contexts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Multicomponent Telehealth Intervention to Improve Oncofertility Care Delivery Among Young Cancer Patients: A Pilot Study. Yang, E., Dornisch, A., Nerb, L., et al.[2023]

A one-year pilot program successfully increased access to fertility preservation (FP) information and services for 22 women newly diagnosed with cancer, primarily breast and cervical cancer, by employing an oncofertility nurse navigator (ONN) to facilitate consultations and coordinate care.

The program improved physician engagement with FP services, leading to more frequent discussions about FP options with patients and timely referrals for consultations, demonstrating that remote cancer centers can effectively provide FP support through telemedicine and local resources.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Expanding Urgent Oncofertility Services for Reproductive Age Women Remote from a Tertiary Level Fertility Centre by Use of Telemedicine and an On-site Nurse Navigator. Zwingerman, R., Melenchuk, K., McMahon, E., et al.[2021]

In a study of 517 young women diagnosed with breast cancer, only 45.6% received specialized oncofertility counseling, highlighting a gap in support for fertility preservation options during treatment.

Among the patients, 16.4% achieved pregnancies post-treatment, primarily through natural conception, indicating that many women can conceive without relying on fertility preservation methods like cryopreservation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pregnancy, fertility concerns and fertility preservation procedures in a national study of French breast cancer survivors. Mangiardi-Veltin, M., Sebbag, C., Rousset-Jablonski, C., et al.[2022]

Survival rates for children with cancer have improved, leading to a greater focus on reducing long-term effects of treatment, such as infertility, making it crucial to discuss fertility preservation options early in the treatment process.

Pediatric surgeons play a vital role in oncofertility by assessing risks and providing both non-experimental and experimental fertility preservation options based on the child's pubertal status and treatment plans, helping families make informed decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A fertility preservation toolkit for pediatric surgeons caring for children with cancer. Lautz, TB., Harris, CJ., Laronda, MM., et al.[2020]

Cancer patients of reproductive age who received oncofertility care reported low emotional distress regarding potential infertility, indicating that such supportive services can significantly alleviate psychological burdens at the time of diagnosis.

The study, which included 30 interviews with patients aged 15 to 44, highlighted the importance of individualized treatment and the positive impact of fertility preservation options, suggesting that these services provide a valuable safety net for future family planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supportive oncofertility care, psychological health and reproductive concerns: a qualitative study. Wang, Y., Logan, S., Stern, K., et al.[2020]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10124175/

A Multicomponent Telehealth Intervention to Improve ...

Purpose: Oncofertility care for pediatric, adolescent, and young adult cancer patients remains under-implemented across adult and pediatric oncology settings.

2.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1551714424001204

Let's TOC Fertility: A stepped wedge cluster randomized ...

A stepped wedge cluster randomized clinical trial to evaluate the effectiveness of the multi-component Telehealth Oncofertility Care (TOC) intervention.

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pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38614445/

Let's TOC Fertility: A stepped wedge cluster randomized ...

A stepped wedge cluster randomized clinical trial to evaluate the effectiveness of the multi-component Telehealth Oncofertility Care (TOC) intervention.

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05443737?tab=results

No Study Results Posted | Evaluation of a Telehealth ...

It identifies the role of the intervention that participants receive. Types of arms include experimental arm, active comparator arm, placebo comparator arm, ...

5.

clinicaltrials.ucsd.edu

clinicaltrials.ucsd.edu/trial/NCT05443737

Telehealth Oncofertility Care Intervention in Adolescent and ...

The purpose of this study is to evaluate the effectiveness of a multi-component intervention to improve young cancer survivors' engagement in goal-concordant ...

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/35639102/

A Multicomponent Telehealth Intervention to Improve ...

Conclusions: We found that the EHR-enabled intervention increased the rate of goal-concordant oncofertility care delivery at an adult oncology program. We also ...

7.

withpower.com

withpower.com/trial/phase-3-fertility-preservation-2022-c5ec5

Telehealth Oncofertility Care for Young Cancer Patients

The purpose of this study is to evaluate the effectiveness of a multi-component intervention to improve young cancer survivors' engagement in ...

8.

researchgate.net

researchgate.net/publication/358844741_A_Multi-Component_Telehealth_Intervention_to_Improve_Oncofertility_Care_Delivery_among_Young_Cancer_Patients_A_Pilot_Study

A Multi-Component Telehealth Intervention to Improve ...

Conclusions We found that the EHR-enabled intervention increased the rate of goal-concordant oncofertility care delivery at an adult oncology program. We also ...