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

• ClinicalTrials.gov Identifier: NCT01152268
• Recruitment Status: Completed
• First Posted: June 29, 2010
• Last Update Posted: March 10, 2015
• Sponsor: St. Jude Children's Research Hospital
• Collaborators: National Institutes of Health (NIH); Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Information provided by (Responsible Party): St. Jude Children's Research Hospital

Study Description

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.

Condition or disease
Cancer

Detailed 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.

Study Design

• Study Type: Observational
• Actual Enrollment: 282 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• 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

Groups and Cohorts

Group/Cohort

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.

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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.

Eligibility Criteria

• Ages Eligible for Study: 13 Years to 21 Years (Child, Adult)
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

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.

Criteria

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.

Contacts and Locations

Locations

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

Canada, Ontario

The Hospital for Sick Children

Toronto, Ontario, Canada, M5G1X8

Sponsors and Collaborators

St. Jude Children's Research Hospital

National Institutes of Health (NIH)

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

• Principal Investigator: James Klosky, Ph.D; St. Jude Children's Research Hospital

More Information

Additional Information:

St. Jude Children's Research Hospital 

Clinical Trials Open at St. Jude 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: St. Jude Children's Research Hospital
• ClinicalTrials.gov Identifier: NCT01152268
• Other Study ID Numbers: SBANK10; R21HD061296-01A2 ( U.S. NIH Grant/Contract )
• First Posted: June 29, 2010
• Last Update Posted: March 10, 2015
• Last Verified: March 2015

Keywords provided by St. Jude Children's Research Hospital:

sperm banking; Adolescent males; Infertility; Adolescents diagnosed with cancer