- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01152268
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.
연구 개요
상태
정황
상세 설명
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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California
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Duarte, California, 미국, 91010
- City of Hope
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Los Angeles, California, 미국, 90095
- Mattel Children's Hospital
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Georgia
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Atlanta, Georgia, 미국, 30342
- Children's Healthcare of Atlanta
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Massachusetts
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Boston, Massachusetts, 미국, 02115
- Dana-Farber Cancer Institute/Children's Hospital Boston
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Michigan
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Ann Arbor, Michigan, 미국, 48109
- The University of Michigan
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Tennessee
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Memphis, Tennessee, 미국, 38105
- St. Jude Children's Research Hospital
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Texas
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Fort Worth, Texas, 미국, 76104
- Cook Children's Medical Center
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Utah
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Salt Lake City, Utah, 미국, 84113
- Primary Children's Medical Center
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Ontario
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Toronto, Ontario, 캐나다, M5G1X8
- The Hospital for Sick Children
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Investigation of factors predictive of sperm banking outcome
기간: 3 years
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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.
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3 years
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Develop and evaluate a Profiling and Referral Tool designed to increase clinical referrals and decrease barriers to sperm banking.
기간: 3 years
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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.
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3 years
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공동 작업자 및 조사자
협력자
수사관
- 수석 연구원: James Klosky, Ph.D, St. Jude Children's Research Hospital
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- SBANK10
- R21HD061296-01A2 (미국 NIH 보조금/계약)
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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