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

6 marca 2015 zaktualizowane przez: 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.

Przegląd badań

Status

Zakończony

Warunki

Nowotwór

Szczegółowy opis

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.

Typ studiów

Obserwacyjny

Zapisy (Rzeczywisty)

282

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

13 lat do 21 lat (Dziecko, Dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Męski

Metoda próbkowania

Próbka bez prawdopodobieństwa

Badana populacja

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.

Opis

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 studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Liczba grup / kohort

Kohorty i interwencje

Grupa / Kohorta
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.

Grupa / Kohorta

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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku	Opis środka	Ramy czasowe
Investigation of factors predictive of sperm banking outcome Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku	Opis środka	Ramy czasowe
Develop and evaluate a Profiling and Referral Tool designed to increase clinical referrals and decrease barriers to sperm banking. Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

St. Jude Children's Research Hospital

Współpracownicy

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

National Institutes of Health (NIH)

Śledczy

Główny śledczy: James Klosky, Ph.D, St. Jude Children's Research Hospital

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

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.

Przydatne linki

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów

1 lipca 2010

Zakończenie podstawowe (Rzeczywisty)

1 czerwca 2014

Ukończenie studiów (Rzeczywisty)