Fertility Preservation in Male AYA With Cancer

Infertility, Male Clinical Trial

Official title:

Optimizing Fertility Preservation and Decision Quality in Male AYA With Cancer: A Family-centered Intervention

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04268004
• Other study ID #: STUDY00000849
• Secondary ID: K08CA237338
• Status: Enrolling by invitation
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: March 31, 2026

Study information

• Verified date: February 2024
• Source: Nationwide Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

A rapidly growing population of male childhood cancer survivors are at risk for infertility and distress. As the number of male cancer survivors rises, it is essential to minimize treatment late effects. One of the most prevalent and significant complications among males is infertility, which can impair psychosocial development and reduce quality of life. National guidelines emphasize offering fertility preservation (FP) prior to initiation of cancer therapy, and sperm cryopreservation is an established and generally noninvasive FP method for pubertal males. Early research suggested only males receiving high doses of alkylating agents should bank sperm. However, variable sperm counts following equivalent doses of cyclophosphamide and scenarios in which patients have to move quickly from "low risk" treatments (which transiently impair sperm production) to "high risk" treatments, support the premise that all males receiving chemotherapy and/or gonadal radiation should consider FP at diagnosis. Despite studies showing ~50% of male childhood cancer survivors have fertility impairment, reports from many centers show only ~25% of pubertal males bank sperm prior to treatment. As survivors enter their reproductive years, many regret missed opportunities for FP and experience distress about potential infertility. Thus, interventions to improve FP uptake would have great potential for reproductive and psychological benefit.

Individual and family factors associated with sperm banking decisions remain poorly understood. Young age, cost, inadequate knowledge, and urgency to start treatment are common barriers to FP among AYA males with newly diagnosed cancer. As a result, most fertility counseling and FP interventions have targeted healthcare providers and systems or provider-patient interactions. While these are critical factors, less than half of male AYA advised about FP in a recent study actually banked sperm, indicating knowledge is not sufficient.

The purpose of this study is to test a decision tool and accompanying guided discussion as a method of improving decision making regarding FP, compared to a standard of care fertility consult.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 40
• Est. completion date: March 31, 2026
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 12 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility
• Infertility, Male

Intervention

Behavioral:
• FP Decision Tool and Discussion
The intervention will be administered by a trained interventionist. The interventionist will administer the digital FP Decision Tool to families in the intervention arm. The tool asks questions examining each AYA's thoughts or feelings regarding parenthood and fertility preservation. The parent version asks the same questions, plus additional questions asking the parent to rate their son's feelings on certain topics (i.e., whether their son wants to have a child, whether their son would be as happy with an adopted child versus a biological child). Items are coded based on the domains of the Health Belief Model (perceived benefits, perceived barriers, perceived threats, self-efficacy, and cues to action). Items are scored and the trained interventionist will facilitate a guided discussion based on the family's responses and discrepancies.

Locations

Country	Name	City	State
United States	Nationwide Children's Hospital	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Leena Nahata	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (5)

Nahata 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. — View Citation

Nahata 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. — View Citation

Nahata 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. — View Citation

Stanek 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. — View Citation

Theroux 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fertility Preservation (FP) Uptake	FP uptake	Baseline to before AYA begins treatment (generally within one to two weeks from baseline)
Secondary	Brief Subjective Decision Quality (BSDQ) Questionnaire - AYA	AYAs will complete the six-item Brief Subjective Decision Quality (BSDQ) Questionnaire with total scores ranging from 1-7; higher scores indicate more satisfaction with their decision.	1-month post randomization
Secondary	Brief Subjective Decision Quality (BSDQ) Questionnaire - Caregiver	Caregivers will complete the six-item Brief Subjective Decision Quality (BSDQ) Questionnaire with total scores ranging from 1-7; higher scores indicate more satisfaction with their decision.	1-month post randomization
Secondary	Brief Subjective Decision Quality (BSDQ) Questionnaire - AYA	AYAs will complete the six-item Brief Subjective Decision Quality (BSDQ) Questionnaire with total scores ranging from 1-7; higher scores indicate more satisfaction with their decision.	1-year post randomization
Secondary	Brief Subjective Decision Quality (BSDQ) Questionnaire - Caregiver	Caregivers will complete the six-item Brief Subjective Decision Quality (BSDQ) Questionnaire with total scores ranging from 1-7; higher scores indicate more satisfaction with their decision.	1-year post randomization