This trial is active, not recruiting.

Condition cancer
Sponsor St. Jude Children's Research Hospital
Collaborator National Institutes of Health (NIH)
Start date July 2010
End date June 2014
Trial size 618 participants
Trial identifier NCT01152268, R21HD061296-01A2, SBANK10


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective
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.

Primary Outcomes

Investigation of factors predictive of sperm banking outcome
time frame: 3 years

Secondary Outcomes

Develop and evaluate a Profiling and Referral Tool designed to increase clinical referrals and decrease barriers to sperm banking.
time frame: 3 years

Eligibility Criteria

Male participants from 13 years up to 21 years old.

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.

Additional Information

Official title Predictors of Adolescent Sperm Banking: Development of a Profiling and Referral Tool
Principal investigator James Klosky, Ph.D
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2014.
Information provided to ClinicalTrials.gov by St. Jude Children's Research Hospital.