Fertility Preservation in Male AYA With Cancer

NCT04268004 | Completed Results DMC

• 2 other identifiers: STUDY00000849K08CA237338
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Infertility, Male

Keywords

Cancer; Fertility Preservation; Parenthood

Outcome Measures

Primary Outcomes (1)

• Fertility Preservation (FP) Uptake

  Fertility Preservation (FP) Uptake (measured by the number of adolescents/adolescents of caregivers who attempted FP)

  Baseline to before AYA begins treatment (generally within one to two weeks from baseline)

Secondary Outcomes (4)

• Brief Subjective Decision Quality (BSDQ) Questionnaire - AYA

  1-month post randomization

• Brief Subjective Decision Quality (BSDQ) Questionnaire - Caregiver

  1-month post randomization

• Brief Subjective Decision Quality (BSDQ) Questionnaire - AYA

  1-year post randomization

• Brief Subjective Decision Quality (BSDQ) Questionnaire - Caregiver

  1-year post randomization

Study Arms (2)

Standard of Care (Control)

NO INTERVENTION

Participants will receive a standard of care fertility consult.

FP Decision Tool and Discussion (Treatment)

EXPERIMENTAL

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.

Behavioral: FP Decision Tool and Discussion

Interventions

FP Decision Tool and Discussion BEHAVIORAL

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.

FP Decision Tool and Discussion (Treatment)

Eligibility Criteria

• Age: 12 Years - 25 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Cognitive deficit that precludes completing measures
• Parents are non-English speaking

Sponsors & Collaborators

• Leena Nahata: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Related Publications (5)

• 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.

  PMID: 31407498 BACKGROUND

• 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.

  PMID: 33564937 BACKGROUND

• 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.

  PMID: 34298773 BACKGROUND

• 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.

  PMID: 34333651 BACKGROUND

• 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.

  PMID: 35171948 BACKGROUND

MeSH Terms

Conditions

Infertility, Male; Neoplasms

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Infertility; Male Urogenital Diseases

Results Point of Contact

• Title: Leena Nahata
• Organization: Nationwide Children's Hospital

leena.nahata@nationwidechildrens.org

6147224502

Study Officials

• Leena Nahata, MD

  Nationwide Children's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants, the interventionist, and research staff will not be blinded.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Families will be randomly assigned to receive standard care or to receive standard care plus the investigator's study intervention. All families will then be followed for a year to assess outcomes.

Study Record Dates

• First Submitted: February 11, 2020
• First Posted: February 13, 2020
• Study Start: February 8, 2021
• Primary Completion: January 4, 2024
• Study Completion: June 1, 2025
• Last Updated: July 29, 2025
• Results First Posted: July 1, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)