Clinical trial · Interventional
Fertility Preservation in Male AYA With Cancer
Optimizing Fertility Preservation and Decision Quality in Male AYA With Cancer: A Family-centered Intervention
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Very little is known about how medical providers can help adolescent and young adults (AYAs) and their caregivers make decisions about fertility preservation (sperm banking) before beginning cancer treatment. The purpose of this study is to see if having a guided conversation about fertility preservation increases preservation rates and/or satisfaction with the decision among AYA males with cancer. The primary hypothesis is that compared to standard of care control group (routine fertility consult at diagnosis, n=20), AYAs in the intervention arm (routine fertility consult at diagnosis + FP Decision Tool and Facilitated Conversation by trained interventionist) will have higher rates of FP uptake. The secondary hypothesis is that families in the intervention group will report better FP decision quality compared to those in the control arm.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Infertility, Male | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FP Decision Tool and Discussion | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Standard of Care (Control)
- description
- Participants will receive a standard of care fertility consult.
- type
- EXPERIMENTAL
- label
- FP Decision Tool and Discussion (Treatment)
- description
- 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.
- interventionNames
- Behavioral: FP Decision Tool and Discussion
Primary outcomes (1)
- measure
- Fertility Preservation (FP) Uptake
- timeFrame
- Baseline to before AYA begins treatment (generally within one to two weeks from baseline)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 12 Years
- Maximum age
- 25 Years
Show eligibility criteria text
Inclusion Criteria: * Male * Aged 12-25 years * Expected to have adjuvant therapy (chemotherapy and/or gonadal radiation) for newly diagnosed cancer * Pubertal (at least Tanner stage 2-3, eligible for sperm banking as determined in the fertility consult) * Proficient in English Exclusion Criteria: * Cognitive deficit that precludes completing measures * Parents are non-English speaking
References
Publications (5)
- BACKGROUNDNahata L, Morgan TL, Lipak KG, Clark OE, Yeager ND, O'Brien SH, Whiteside S, Audino A, Quinn GP, Gerhardt CA. Perceptions of participating in family-centered fertility research among adolescent and young adult males newly diagnosed with cancer: A qualitative study. Pediatr Blood Cancer. 2019 Nov;66(11):e27966. doi: 10.1002/pbc.27966. Epub 2019 Aug 12. PMID 31407498
- BACKGROUNDNahata L, Dattilo TM, Olsavsky AL, Lipak KG, Whiteside S, Yeager ND, Audino A, Klosky JL, Rausch J, Saraf A, O'Brien SH, Quinn GP, Gerhardt CA. Impact of a novel family-centered values clarification tool on adolescent sperm banking attempts at the time of a new cancer diagnosis. J Assist Reprod Genet. 2021 Jun;38(6):1561-1569. doi: 10.1007/s10815-021-02092-6. Epub 2021 Feb 10. PMID 33564937
- BACKGROUNDTheroux CI, Hill KN, Olsavsky AL, Klosky JL, Yeager ND, Audino A, O'Brien SH, Quinn GP, Gerhardt CA, Nahata L. Satisfaction with Fertility Preservation Decisions among Adolescent Males with Cancer: A Mixed Methods Study. Cancers (Basel). 2021 Jul 16;13(14):3559. doi: 10.3390/cancers13143559. PMID 34298773
- BACKGROUNDNahata L, Olsavsky A, Dattilo TM, Lipak KG, Whiteside S, Yeager ND, Audino A, Rausch J, Klosky JL, O'Brien SH, Quinn GP, Gerhardt CA. Parent-Adolescent Concordance Regarding Fertility Perspectives and Sperm Banking Attempts in Adolescent Males With Cancer. J Pediatr Psychol. 2021 Oct 18;46(10):1149-1158. doi: 10.1093/jpepsy/jsab069. PMID 34333651
- BACKGROUNDStanek C, Theroux CI, Olsavsky AL, Hill KN, Rausch JR, O'Brien SH, Quinn GP, Gerhardt CA, Nahata L. Study protocol for fertility preservation discussions and decisions: A family-centered psychoeducational intervention for male adolescents and emerging adults newly diagnosed with cancer and their families. PLoS One. 2022 Feb 16;17(2):e0263886. doi: 10.1371/journal.pone.0263886. eCollection 2022. PMID 35171948