Sperm Banking Among Adolescents Newly Diagnosed With Cancer: Development of a Profiling and Referral Tool
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|ClinicalTrials.gov Identifier: NCT01152268|
Recruitment Status : Completed
First Posted : June 29, 2010
Last Update Posted : March 10, 2015
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.
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||282 participants|
|Official Title:||Predictors of Adolescent Sperm Banking: Development of a Profiling and Referral Tool|
|Study Start Date :||July 2010|
|Actual Primary Completion Date :||June 2014|
|Actual Study Completion Date :||June 2014|
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.
- Investigation of factors predictive of sperm banking outcome [ Time Frame: 3 years ]Investigate factors predictive of banking sperm/not banking sperm among at-risk adolescents newly diagnosed with cancer. Psychological, health belief, demographic, developmental, parental/guardian, provider, and medical factors will be tested in models of sperm banking outcome.
- Develop and evaluate a Profiling and Referral Tool designed to increase clinical referrals and decrease barriers to sperm banking. [ Time Frame: 3 years ]To utilize factors most predictive of sperm banking outcome to develop a brief Profiling and Referral Tool designed to increase sperm banking among teens newly diagnosed with cancer. Implementation of the developed Profiling and Referral Tool will be feasible based on provider and family report.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01152268
|United States, California|
|City of Hope|
|Duarte, California, United States, 91010|
|Mattel Children's Hospital|
|Los Angeles, California, United States, 90095|
|United States, Georgia|
|Children's Healthcare of Atlanta|
|Atlanta, Georgia, United States, 30342|
|United States, Massachusetts|
|Dana-Farber Cancer Institute/Children's Hospital Boston|
|Boston, Massachusetts, United States, 02115|
|United States, Michigan|
|The University of Michigan|
|Ann Arbor, Michigan, United States, 48109|
|United States, Tennessee|
|St. Jude Children's Research Hospital|
|Memphis, Tennessee, United States, 38105|
|United States, Texas|
|Cook Children's Medical Center|
|Fort Worth, Texas, United States, 76104|
|United States, Utah|
|Primary Children's Medical Center|
|Salt Lake City, Utah, United States, 84113|
|The Hospital for Sick Children|
|Toronto, Ontario, Canada, M5G1X8|
|Principal Investigator:||James Klosky, Ph.D||St. Jude Children's Research Hospital|