- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01152268
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
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.
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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Ontario
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Toronto, Ontario, Canada, M5G1X8
- The Hospital for Sick Children
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California
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Duarte, California, Forenede Stater, 91010
- City of Hope
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Los Angeles, California, Forenede Stater, 90095
- Mattel Children's Hospital
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Georgia
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Atlanta, Georgia, Forenede Stater, 30342
- Children's Healthcare of Atlanta
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02115
- Dana-Farber Cancer Institute/Children's Hospital Boston
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Michigan
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Ann Arbor, Michigan, Forenede Stater, 48109
- The University of Michigan
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Tennessee
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Memphis, Tennessee, Forenede Stater, 38105
- St. Jude Children's Research Hospital
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Texas
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Fort Worth, Texas, Forenede Stater, 76104
- Cook Children's Medical Center
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Utah
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Salt Lake City, Utah, Forenede Stater, 84113
- Primary Children's Medical Center
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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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.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Investigation of factors predictive of sperm banking outcome
Tidsramme: 3 years
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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.
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3 years
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Develop and evaluate a Profiling and Referral Tool designed to increase clinical referrals and decrease barriers to sperm banking.
Tidsramme: 3 years
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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.
|
3 years
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Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: James Klosky, Ph.D, St. Jude Children's Research Hospital
Publikationer og nyttige links
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- SBANK10
- R21HD061296-01A2 (U.S. NIH-bevilling/kontrakt)
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