Stakeholder-Engaged Development and Evaluation of a Screening Approach for Sexual Dysfunction in Adolescent and Young Adult Patients With and Surviving Childhood Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 205
- 试验地点
- 4
- 主要终点
- Comparison of sexual function communication before and after intervention implementation
研究概览
简要总结
Prior research determined adolescent and young adult-aged childhood cancer survivor (AYA-CCS) and medical provider acceptability of the SexFS Brief in a controlled research setting. Development of an acceptable, effective, and feasible screening approach will result in improved recognition of SD in AYA patients with and surviving childhood cancer.
详细描述
Detailed Description:
To adhere to National Comprehensive Cancer Network (NCCN) Adolescent and young adult (AYA) and Survivorship Guidelines, the Investigator will be developing and implementing a standardized screening approach for sexual function using the Patient Reported Outcome Measurement Information System (PROMIS) for Sexual Function and Satisfaction (SexFS) Brief. The overarching goal of this proposal is to develop and pilot test a patient-centered approach to assessing AYA patients with and surviving childhood cancer (age 15-24) for SD.
Prior to the clinical trial, Aim 1 of this study will integrate patient and provider feedback to refine an approach to standardized sexual function screening. Once Aim 1 has been completed, the study protocol will be amended to update intervention details prior to proceeding with implementation across all clinics as routine clinical care.
Aims 2 and 3 involve a pilot type 1 hybrid effectiveness-implementation trial using a pre-post design. Prior to implementation of the intervention, data on sexual function screening and patient satisfaction will be collected through surveys and medical record review. Subsequently, the sexual function screening intervention will be implemented clinic-wide as standard of care for patients age 15-24 years with or surviving childhood cancer. Following implementation of the screening approach, post-implementation data (effectiveness and implementation outcomes) will be collecting via survey and EHR review in consenting patients. After effectiveness data collection is complete, implementation outcomes will also be assessed via surveys and interviews with consenting provider stakeholders.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 24 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Pre-Implementation of Routine Sexual Function Screening (Baseline)
This arm will include patients with and surviving cancer who are seen during the Pre-Implementation study period. It will include patients diagnosed prior to age 18 years and 15-24 years old at the time of study. Patients will be approached by research personnel at the end of each visit for participation in a survey. The pre-implementation survey will assess sexual function communication and patient satisfaction. In addition, medical record data abstraction of clinical care related to sexual health and function will be collected.
Post-Implementation of Routine Sexual Function Screening
This arm will include patients with and surviving cancer who are seen during the Post-Implementation study period, once the routine sexual function screening intervention has been implemented. It will include patients diagnosed prior to age 18 years and 15-24 years old at the time of study. Patients will be approached by research personnel at the end of each visit for participation in a survey. The post-implementation survey will assess sexual function communication and patient satisfaction, as well as measures of acceptability, feasibility, and appropriateness of the intervention. In addition, medical record data abstraction of clinical care related to sexual health and function will be collected.
干预措施: Sexual Function Screening Approach (Behavioral)
结局指标
主要结局
Comparison of sexual function communication before and after intervention implementation
时间窗: 5 years
Comparison of pre- and post- intervention percentage of patients reporting that his/her provider has communicated with them about sexual function Subjects will report (yes or no) via survey after their healthcare visit.
次要结局
- Comparison of patient satisfaction before and after intervention implementation(5 years)
- Adoption of the screening tool by medical stakeholders (self-reported results review)(5 years)
- Provider-reported feasibility of the sexual function screening approach(5 years)
- Evaluate implementation of the standardized screening approach by fidelity (patient-reported)(5 years)
- Comparison of healthcare needs being met before and after intervention implementation(5 years)
- Reach - proportion of eligible patients who completed sexual function screening(5 years)
- Representativeness - sociodemographic characteristics of patients who received and did not receive screening(5 years)
- Adoption of the screening tool by medical stakeholders (self-reported results discussion)(5 years)
- Provider-reported acceptability of the sexual function screening approach(5 years)
- Provider-reported appropriateness of the sexual function screening approach(5 years)
- Evaluate implementation of the standardized screening approach by fidelity (direct observation)(5 years)
- Contextual factors influencing implementation success(5 years)
- Patient-reported acceptability of the sexual function screening approach(5 years)
- Patient-reported appropriateness of the sexual function screening approach(5 years)
- Patient-reported feasibility of the sexual function screening approach(5 years)