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临床试验/NCT04268004
NCT04268004已完成不适用

Optimizing Fertility Preservation and Decision Quality in Male AYA With Cancer: A Family-centered Intervention

Leena Nahata1 个研究点 分布在 1 个国家目标入组 53 人开始时间: 2021年2月8日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
53
试验地点
1
主要终点
Fertility Preservation (FP) Uptake

研究概览

简要总结

Very little is known about how medical providers can help adolescent and young adults (AYAs) and their caregivers make decisions about fertility preservation (sperm banking) before beginning cancer treatment. The purpose of this study is to see if having a guided conversation about fertility preservation increases preservation rates and/or satisfaction with the decision among AYA males with cancer. The primary hypothesis is that compared to standard of care control group (routine fertility consult at diagnosis, n=20), AYAs in the intervention arm (routine fertility consult at diagnosis + FP Decision Tool and Facilitated Conversation by trained interventionist) will have higher rates of FP uptake. The secondary hypothesis is that families in the intervention group will report better FP decision quality compared to those in the control arm.

详细描述

A rapidly growing population of male childhood cancer survivors are at risk for infertility and distress. As the number of male cancer survivors rises, it is essential to minimize treatment late effects. One of the most prevalent and significant complications among males is infertility, which can impair psychosocial development and reduce quality of life. National guidelines emphasize offering fertility preservation (FP) prior to initiation of cancer therapy, and sperm cryopreservation is an established and generally noninvasive FP method for pubertal males. Early research suggested only males receiving high doses of alkylating agents should bank sperm. However, variable sperm counts following equivalent doses of cyclophosphamide and scenarios in which patients have to move quickly from "low risk" treatments (which transiently impair sperm production) to "high risk" treatments, support the premise that all males receiving chemotherapy and/or gonadal radiation should consider FP at diagnosis. Despite studies showing ~50% of male childhood cancer survivors have fertility impairment, reports from many centers show only ~25% of pubertal males bank sperm prior to treatment. As survivors enter their reproductive years, many regret missed opportunities for FP and experience distress about potential infertility. Thus, interventions to improve FP uptake would have great potential for reproductive and psychological benefit.

Individual and family factors associated with sperm banking decisions remain poorly understood. Young age, cost, inadequate knowledge, and urgency to start treatment are common barriers to FP among AYA males with newly diagnosed cancer. As a result, most fertility counseling and FP interventions have targeted healthcare providers and systems or provider-patient interactions. While these are critical factors, less than half of male AYA advised about FP in a recent study actually banked sperm, indicating knowledge is not sufficient.

The purpose of this study is to test a decision tool and accompanying guided discussion as a method of improving decision making regarding FP, compared to a standard of care fertility consult.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Double (Investigator, Outcomes Assessor)

盲法说明

Participants, the interventionist, and research staff will not be blinded.

入排标准

年龄范围
12 Years 至 25 Years(Child, Adult)
性别
Male
接受健康志愿者
否

入选标准

  • •Aged 12-25 years
  • •Expected to have adjuvant therapy (chemotherapy and/or gonadal radiation) for newly diagnosed cancer
  • •Pubertal (at least Tanner stage 2-3, eligible for sperm banking as determined in the fertility consult)
  • •Proficient in English

排除标准

  • •Cognitive deficit that precludes completing measures
  • •Parents are non-English speaking

研究组 & 干预措施

Standard of Care (Control)

No Intervention

Participants will receive a standard of care fertility consult.

FP Decision Tool and Discussion (Treatment)

Experimental

Participants will receive a standard of care fertility consult and will participate in a family-centered psychoeducational intervention consisting of completing a FP Decision Tool and participating in a guided discussion about responses and discrepancies identified in the FP Decision Tool.

干预措施: FP Decision Tool and Discussion (Behavioral)

结局指标

主要结局

Fertility Preservation (FP) Uptake

时间窗: Baseline to before AYA begins treatment (generally within one to two weeks from baseline)

Fertility Preservation (FP) Uptake (measured by the number of adolescents/adolescents of caregivers who attempted FP)

Fertility Preservation (FP) Uptake

时间窗: Baseline to before AYA begins treatment (generally within one to two weeks from baseline)

Fertility Preservation (FP) Uptake (measured by the number of adolescents/adolescents of caregivers who attempted FP)

次要结局

  • Brief Subjective Decision Quality (BSDQ) Questionnaire - AYA(1-year post randomization)
  • Brief Subjective Decision Quality (BSDQ) Questionnaire - Caregiver(1-year post randomization)
  • Brief Subjective Decision Quality (BSDQ) Questionnaire - AYA(1-month post randomization)
  • Brief Subjective Decision Quality (BSDQ) Questionnaire - Caregiver(1-month post randomization)

研究者

发起方
Leena Nahata
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Leena Nahata

Principal Investigator

Nationwide Children's Hospital

研究点 (1)

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