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

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the treatment Telehealth Oncofertility Care for young cancer patients?

Research shows that using telehealth and on-site nurse navigators can improve access to fertility preservation services for young cancer patients, making it easier for them to get the care they need without traveling far. Additionally, a pilot study found that a telehealth-based oncofertility intervention increased the rate of appropriate fertility care delivery in an adult oncology program. ^{1 2 3 4 5}

Is Telehealth Oncofertility Care safe for young cancer patients?

The studies on Telehealth Oncofertility Care suggest that it is generally safe for young cancer patients, as it focuses on improving access to fertility preservation services and involves consultations with healthcare providers. No specific safety concerns were reported in the studies. ^{1 4 5 6 7}

How is the Telehealth Oncofertility Care treatment different from other oncofertility treatments?

Telehealth Oncofertility Care is unique because it uses telemedicine to provide fertility preservation information and services to young cancer patients who are far from specialized fertility centers, minimizing the need for travel. This approach includes a dedicated oncofertility nurse navigator who coordinates care and consultations, making it more accessible and convenient compared to traditional in-person fertility preservation services. ^{1 2 8 9 10}

Research Team

H. Irene Su, MD, MSCE

Principal Investigator

University of California, San Diego

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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 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]

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]

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]

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]

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]

References

1. England 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. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Oncofertility care in young women and the outcomes of pregnancy over the last 5 years. [2022]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Patient perspectives of telehealth for fertility care: a national survey. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Theory-Guided Development of Fertility Care Implementation Strategies for Adolescent and Young Adult Cancer Survivors. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

A Multicomponent Telehealth Intervention to Improve Oncofertility Care Delivery Among Young Cancer Patients: A Pilot Study. [2023]

6. England 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. [2020]

7. Germany pubmed.ncbi.nlm.nih.gov

Fertility navigators in female oncofertility care in an academic medical center: a qualitative evaluation. [2021]

8. Germany pubmed.ncbi.nlm.nih.gov

Supportive oncofertility care, psychological health and reproductive concerns: a qualitative study. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

A fertility preservation toolkit for pediatric surgeons caring for children with cancer. [2020]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Pregnancy, fertility concerns and fertility preservation procedures in a national study of French breast cancer survivors. [2022]