Sperm Banking Among Adolescents Newly Diagnosed With Cancer: Development of a Profiling and Referral Tool
Predictors of Adolescent Sperm Banking: Development of a Profiling and Referral Tool
2 other identifiers
observational
282
2 countries
9
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2010
Longer than P75 for all trials
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 25, 2010
CompletedFirst Posted
Study publicly available on registry
June 29, 2010
CompletedStudy Start
First participant enrolled
July 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedMarch 10, 2015
March 1, 2015
3.9 years
June 25, 2010
March 6, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Investigation of factors predictive of sperm banking outcome
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.
3 years
Secondary Outcomes (1)
Develop and evaluate a Profiling and Referral Tool designed to increase clinical referrals and decrease barriers to sperm banking.
3 years
Study Arms (1)
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.
Eligibility Criteria
Male Adolescents meeting eligibility criteria will be identified by updated clinic lists that are available across all institutions included in this study. After the review of clinic lists, medical record review, and report from oncologist regarding patient risk for treatment-related infertility, patients meeting study criteria will be recruited consecutively within the time constraints of the available staff. That is, for every opportunity where there is staff available for recruitment, the study team will attempt to enroll the first available patient meeting eligibility criteria.
You may qualify if:
- 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.
You may not qualify if:
- Participant previously treated for cancer.
- History of mental retardation or severe cognitive or learning impairment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
City of Hope
Duarte, California, 91010, United States
Mattel Children's Hospital
Los Angeles, California, 90095, United States
Children's Healthcare of Atlanta
Atlanta, Georgia, 30342, United States
Dana-Farber Cancer Institute/Children's Hospital Boston
Boston, Massachusetts, 02115, United States
The University of Michigan
Ann Arbor, Michigan, 48109, United States
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105, United States
Cook Children's Medical Center
Fort Worth, Texas, 76104, United States
Primary Children's Medical Center
Salt Lake City, Utah, 84113, United States
The Hospital for Sick Children
Toronto, Ontario, M5G1X8, Canada
Related Publications (1)
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.
PMID: 29202957DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
James Klosky, Ph.D
St. Jude Children's Research Hospital
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 25, 2010
First Posted
June 29, 2010
Study Start
July 1, 2010
Primary Completion
June 1, 2014
Study Completion
June 1, 2014
Last Updated
March 10, 2015
Record last verified: 2015-03