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.

Study Overview

• Status: Completed
• Conditions: 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 Type: Observational
• Enrollment (Actual): 282

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G1X8
      • The Hospital for Sick Children
• United States
  • California
    • Duarte, California, United States, 91010
      • City of Hope
    • Los Angeles, California, United States, 90095
      • Mattel Children's Hospital
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Children's Healthcare of Atlanta
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Dana-Farber Cancer Institute/Children's Hospital Boston
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • The University of Michigan
  • Tennessee
    • Memphis, Tennessee, United States, 38105
      • St. Jude Children's Research Hospital
  • Texas
    • Fort Worth, Texas, United States, 76104
      • Cook Children's Medical Center
  • Utah
    • Salt Lake City, Utah, United States, 84113
      • Primary Children's Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 21 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: St. Jude Children's Research Hospital
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); National Institutes of Health (NIH)
• Investigators: Principal Investigator: James Klosky, Ph.D, St. Jude Children's Research Hospital

Publications and helpful links

General Publications

• 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.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: June 25, 2010
• First Submitted That Met QC Criteria: June 28, 2010
• First Posted (Estimate): June 29, 2010

Study Record Updates

• Last Update Posted (Estimate): March 10, 2015
• Last Update Submitted That Met QC Criteria: March 6, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: Infertility; sperm banking; Adolescent males; Adolescents diagnosed with cancer
• Other Study ID Numbers: SBANK10; R21HD061296-01A2 (U.S. NIH Grant/Contract)