Sperm Banking Among Adolescents Newly Diagnosed With Cancer: Development of a Profiling and Referral Tool

Cancer Clinical Trial

Official title:

Predictors of Adolescent Sperm Banking: Development of a Profiling and Referral Tool

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01152268
• Other study ID #: SBANK10
• Secondary ID: R21HD061296-01A2
• Status: Completed
• Phase: N/A
• First received: June 25, 2010
• Last updated: March 6, 2015
• Start date: July 2010
• Est. completion date: June 2014

Study information

• Verified date: March 2015
• Source: St. Jude Children's Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 282
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 13 Years to 21 Years

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cancer

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario
United States	The University of Michigan	Ann Arbor	Michigan
United States	Children's Healthcare of Atlanta	Atlanta	Georgia
United States	Dana-Farber Cancer Institute/Children's Hospital Boston	Boston	Massachusetts
United States	City of Hope	Duarte	California
United States	Cook Children's Medical Center	Fort Worth	Texas
United States	Mattel Children's Hospital	Los Angeles	California
United States	St. Jude Children's Research Hospital	Memphis	Tennessee
United States	Primary Children's Medical Center	Salt Lake City	Utah

Sponsors (3)

Lead Sponsor	Collaborator
St. Jude Children's Research Hospital	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH)

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Develop and evaluate a Profiling and Referral Tool designed to increase clinical referrals and decrease barriers to sperm banking.	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	No

External Links

•   Clinical Trials Open at St. Jude
•   St. Jude Children's Research Hospital