Sperm Banking Among Adolescents Newly Diagnosed With Cancer: Development of a Profiling and Referral Tool
This trial is active, not recruiting.
|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|
|Duarte, CA||City of Hope||no longer recruiting|
|Los Angeles, CA||Mattel Children's Hospital||no longer recruiting|
|Atlanta, GA||Children's Healthcare of Atlanta||no longer recruiting|
|Boston, MA||Dana-Farber Cancer Institute/Children's Hospital Boston||no longer recruiting|
|Ann Arbor, MI||The University of Michigan||no longer recruiting|
|Memphis, TN||St. Jude Children's Research Hospital||no longer recruiting|
|Forth Worth, TX||Cook's Children's Medical Center||no longer recruiting|
|Salt Lake City, UT||Primary Children's Medical Center||no longer recruiting|
|Toronto, Canada||The Hospital for Sick Children||no longer recruiting|
Investigation of factors predictive of sperm banking outcome
time frame: 3 years
Develop and evaluate a Profiling and Referral Tool designed to increase clinical referrals and decrease barriers to sperm banking.
time frame: 3 years
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.
|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.|
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