Sperm Banking Among Adolescents Newly Diagnosed With Cancer: Development of a Profiling and Referral Tool
6 de marzo de 2015 actualizado por: St. Jude Children's Research Hospital
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.
Descripción general del estudio
Estado
Terminado
Condiciones
Descripción detallada
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.
Tipo de estudio
De observación
Inscripción (Actual)
282
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
Ontario
-
Toronto, Ontario, Canadá, M5G1X8
- The Hospital for Sick Children
-
-
-
-
California
-
Duarte, California, Estados Unidos, 91010
- City of Hope
-
Los Angeles, California, Estados Unidos, 90095
- Mattel Children's Hospital
-
-
Georgia
-
Atlanta, Georgia, Estados Unidos, 30342
- Children's Healthcare of Atlanta
-
-
Massachusetts
-
Boston, Massachusetts, Estados Unidos, 02115
- Dana-Farber Cancer Institute/Children's Hospital Boston
-
-
Michigan
-
Ann Arbor, Michigan, Estados Unidos, 48109
- The University of Michigan
-
-
Tennessee
-
Memphis, Tennessee, Estados Unidos, 38105
- St. Jude Children's Research Hospital
-
-
Texas
-
Fort Worth, Texas, Estados Unidos, 76104
- Cook Children's Medical Center
-
-
Utah
-
Salt Lake City, Utah, Estados Unidos, 84113
- Primary Children's Medical Center
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
13 años a 21 años (Niño, Adulto)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Masculino
Método de muestreo
Muestra no probabilística
Población de estudio
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.
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
|---|
|
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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Investigation of factors predictive of sperm banking outcome
Periodo de tiempo: 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.
|
3 years
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Develop and evaluate a Profiling and Referral Tool designed to increase clinical referrals and decrease barriers to sperm banking.
Periodo de tiempo: 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.
|
3 years
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: James Klosky, Ph.D, St. Jude Children's Research Hospital
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de julio de 2010
Finalización primaria (Actual)
1 de junio de 2014
Finalización del estudio (Actual)
1 de junio de 2014
Fechas de registro del estudio
Enviado por primera vez
25 de junio de 2010
Primero enviado que cumplió con los criterios de control de calidad
28 de junio de 2010
Publicado por primera vez (Estimar)
29 de junio de 2010
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
10 de marzo de 2015
Última actualización enviada que cumplió con los criterios de control de calidad
6 de marzo de 2015
Última verificación
1 de marzo de 2015
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- SBANK10
- R21HD061296-01A2 (Subvención/contrato del NIH de EE. UU.)
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .