Sperm Banking Among Adolescents Newly Diagnosed With Cancer: Development of a Profiling and Referral Tool

NCT ID: NCT01152268

Last Updated: 2015-03-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 282 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2014-06-30

Brief Summary

Despite the known adverse effects of specific cancer treatments on fertility, only 18-26% of at-risk adolescents and young men cryopreserve sperm prior to cancer treatment in the US: These already less than optimal rates of sperm banking are even lower among adolescents who have increased anxiety at cancer diagnosis, are lower in age and socioeconomic status, of Evangelical religious orientation, or are diagnosed with leukemia/lymphoma: It is not clear why sperm banking is underutilized, particularly in light of the high priority that survivors of childhood cancer place on fertility and the high psychological distress associated with fertility loss. Studies addressing sperm banking among adults with cancer suggest that factors such as poor physician communication and the resulting lack of fertility-risk knowledge by patients contributes to the low frequency of sperm cryopreservation. No well-designed studies have examined risk factors associated with failure to bank sperm among adolescents with cancer, a developmentally distinct population ripe for intervention.

This study plans to enroll 206 adolescent males and 412 parents/guardians.

Detailed Description

This study will identify factors predictive of sperm banking/not sperm banking in order to design interventions for increasing fertility preservation among adolescent males newly diagnosed with cancer. Specifically, this study aims to investigate psychological, demographic, developmental, parent/guardian, provider, and medical factors predictive of sperm banking outcomes among at-risk adolescents with cancer. Once these factors have been identified, the study will develop a novel Profiling and Referral Tool. This instrument will ultimately serve as an intervention for both healthcare providers and families through the facilitation of appropriate referrals, and tailored interventions for decreasing barriers to sperm banking. Finally, the feasibility of the Profiling and Referral tool will be evaluated based on provider and family report.

Conditions

Cancer

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Adolescent Male Participants

Self-report questionnaire data will be collected one time, between Days 1-7 post initiation of cancer therapy(e.g. Days 2-8 of being "on-treatment" for cancer) among eligible participants and their families who enroll on the study. Patients who agree to participate will be asked to complete a battery of paper and pencil questionnaires (which will also be available on-line if preferred) that assess risk/protective factors for sperm banking. When the banking recommendation is "Yes" or "further assessment required," the profiling and referral tool will be given to the family and instructions for completion will be provided. The tool will include a list of key items which will be based on the most influential barriers to banking sperm.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Male participants newly diagnosed with cancer.
• Patients must be between 13 years of age (≥ 13 years) and 21 years of age (< 22 years) at time of study enrollment.
• Participant Identified as Tanner stage III or higher.
• Participant identified by his oncologist (or designee) as being at risk for treatment-related infertility.
• Proficiency speaking and reading English or Spanish.
• Cognitive capacity to complete study questionnaires.

Exclusion Criteria

• Participant previously treated for cancer.
• History of mental retardation or severe cognitive or learning impairment.

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 21 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

St. Jude Children's Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

James Klosky, Ph.D

Role: PRINCIPAL_INVESTIGATOR

St. Jude Children's Research Hospital

Locations

City of Hope

Duarte, California, United States

Mattel Children's Hospital

Los Angeles, California, United States

Children's Healthcare of Atlanta

Atlanta, Georgia, United States

Dana-Farber Cancer Institute/Children's Hospital Boston

Boston, Massachusetts, United States

The University of Michigan

Ann Arbor, Michigan, United States

St. Jude Children's Research Hospital

Memphis, Tennessee, United States

Cook Children's Medical Center

Fort Worth, Texas, United States

Primary Children's Medical Center

Salt Lake City, Utah, United States

The Hospital for Sick Children

Toronto, Ontario, Canada

Countries

United States; Canada

References

Klosky JL, Flynn JS, Lehmann V, Russell KM, Wang F, Hardin RN, Eddinger JR, Zhang H, Schenck LA, Schover LR. Parental influences on sperm banking attempts among adolescent males newly diagnosed with cancer. Fertil Steril. 2017 Dec;108(6):1043-1049. doi: 10.1016/j.fertnstert.2017.08.039.

Reference Type: DERIVED

PMID: 29202957 (View on PubMed)

Related Links

http://www.stjude.org

St. Jude Children's Research Hospital

http://www.stjude.org/protocols

Clinical Trials Open at St. Jude

Other Identifiers

R21HD061296-01A2

Identifier Type: NIH

Identifier Source: secondary_id

View Link

SBANK10

Identifier Type: -

Identifier Source: org_study_id