Fertility Preservation Discussion for Cancer

Age: < 65

Sex: Male

Trial Phase: Academic

Sponsor: Leena Nahata

Disqualifiers: Cognitive deficit, Non-English speaking parents

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

Compensation: Varies

Number of Visits: 2

Duration: Varies based on individual treatment plans

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a guided conversation about fertility preservation (sperm banking) can assist young males with cancer in making informed decisions before starting treatment. Participants will receive either the standard fertility consult or the consult plus a special decision tool and discussion (FP Decision Tool and Discussion). The researchers aim to discover if this additional support results in higher rates of fertility preservation and greater satisfaction with the decision. The trial is suitable for males aged 12-25 who are about to begin chemotherapy or radiation and can engage in a discussion about fertility options. As an unphased trial, this study provides a unique opportunity to contribute to research that could enhance decision-making support for future patients.

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 prior data suggests that this protocol is safe for adolescent and young adults with cancer?

Research has shown that using a fertility preservation (FP) decision tool along with guided discussions is generally safe and well-received. In early testing, families found these tools helpful, and more people chose to bank sperm after using them. These studies reported no negative effects or safety issues. This suggests that the decision tool and discussions are safe options for those considering fertility preservation before cancer treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the FP Decision Tool and Discussion because it offers a fresh, family-centered approach to fertility preservation discussions for cancer patients. Unlike the standard fertility consults, this method involves a comprehensive tool that helps identify and discuss discrepancies in responses, which can lead to more personalized and informed decision-making for patients and their families. By facilitating open and guided discussions, this approach aims to empower patients with better understanding and support, potentially leading to more informed fertility-related choices during a challenging time.

What evidence suggests that this FP Decision Tool and Discussion is effective for increasing fertility preservation rates in AYA males with cancer?

Research has shown that planned discussions about fertility preservation options can help young cancer patients make better decisions. In this trial, participants in the FP Decision Tool and Discussion arm will use a decision-making tool and engage in a guided discussion. Studies have found that this approach can reduce uncertainty and stress about fertility choices. Although some studies mention challenges like limited time, this method appears promising in increasing patient satisfaction with fertility decisions. The aim is to help young patients feel more confident and supported when deciding about sperm banking before starting cancer treatment. ^{1 3 4 5 6}

Who Is on the Research Team?

Leena Nahata, MD

Principal Investigator

Nationwide Children's Hospital

Are You a Good Fit for This Trial?

This trial is for young males aged 12-25 with a new cancer diagnosis who are about to start treatment that could affect fertility. They must understand English and be at a certain stage of puberty to bank sperm. It's not for those with cognitive issues or non-English speaking parents.

Inclusion Criteria

I am expected to undergo additional therapy after my initial cancer treatment.

I am male.

I am in puberty and eligible for sperm banking.

Exclusion Criteria

Your parents do not speak English.

I have difficulty with thinking or memory that makes it hard for me to complete tasks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Fertility Preservation Decision Intervention

Participants receive a standard fertility consult and may participate in a family-centered psychoeducational intervention with a FP Decision Tool and guided discussion

1-2 weeks

1 visit (in-person)

Treatment

Participants begin cancer treatment following fertility preservation decision-making

Varies based on individual treatment plans

Follow-up

Participants are monitored for decision quality and satisfaction with fertility preservation decisions

1 year

Periodic assessments (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• FP Decision Tool and Discussion

Trial Overview The study tests if a special tool and conversation about sperm banking before cancer treatment can help increase the number of young men preserving their fertility and improve satisfaction with their decision, compared to just getting routine fertility advice.

How Is the Trial Designed?

Group I: FP Decision Tool and Discussion (Treatment) Experimental Treatment 1 Intervention

Participants will receive a standard of care fertility consult and will participate in a family-centered psychoeducational intervention consisting of completing a FP Decision Tool and participating in a guided discussion about responses and discrepancies identified in the FP Decision Tool.

Group II: Standard of Care (Control) Active Control 1 Intervention

Participants will receive a standard of care fertility consult.

Who Is Running the Clinical Trial?

Leena Nahata

Lead Sponsor

Trials

1

Recruited

40+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12535711/

Decision-Making About Fertility Preservation After Cancer ... This qualitative study aimed to examine the patient perceptions of the FP decision and to identify barriers and unmet needs, addressing a ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40372254/

Fertility Preservation Discussions And Decisions - PubMed - NIH FP-DAD had high acceptability, though feasibility challenges (e.g., time contraints) limited full family participation. Findings showed limited efficacy, ...

3. ascopubs.org ascopubs.org/doi/10.1200/JCO-24-02782

Fertility Preservation in People With Cancer Outcomes: maintenance of fertility (live [healthy] birth [gold standard] or surrogate end points), such as ovarian reserve (anti-Müllerian ...

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1002/pbc.31795

Fertility Preservation Discussions And Decisions: Results ... The aims of this pilot RCT were to (i) assess feasibility and acceptability of FP-DAD, and (ii) examine efficacy of FP-DAD with regard to ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT07038174

A Study to Evaluate the Effectiveness of a Web-based Tool ... The use of a web-based decision aid for fertility preservation will: Reduce decisional conflict experienced by cancer patients during the decision-making ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12352208/

Development and pilot testing of a personalised decision ... However, discussions and decision-making about fertility preservation before cancer treatment have been insufficient owing to barriers in the ...