Improving Health-Related Quality of Life Communication Between AYA Oncology Patients and Clinicians: A Patient-Centered Intervention
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Feasibility of implementing the ReSPECT intervention.
研究概览
简要总结
The overarching goal is to develop and demonstrate proof-of-concept of ReSPECT (Reproductive and Sexual Health Patient Education and Communication Tool), a multi-modal communication intervention to improve adolescent and young adult (AYA)- clinician sexual and reproductive health (SRH) communication in the outpatient oncology clinic setting.
详细描述
To improve sexual and reproductive health communication between adolescent and young adult oncology patients and their clinicians, the Investigator will be developing and testing proof-of-concept of a novel web-based intervention called ReSPECT (Reproductive and Sexual health Patient Education and Communication Tool). The overarching goal of this proposal is to develop and pilot test a patient-centered approach to improve sexual and reproductive health communication during cancer care.
Prior to the clinical trial, Aim 1 of this study will develop and refine ReSPECT by integrating feedback from AYAs and pediatric oncology clinicians on individual intervention components followed by additional feedback collected through cognitive debriefing. Once Aim 1 is completed, the intervention will be ready for proof-of-concept testing.
Aims 2 and 3 involve a single-arm cohort study of the ReSPECT intervention using a pre-post design. Enrolled participants will complete a survey at baseline, immediately after intervention use, and at 2 months from study enrollment. All participants will also be invited to participate in a brief interview immediately after intervention use.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adolescent and Young Adult Oncology Patients
- •In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- •Be aged 15-25 years old at time of enrollment.
- •Have a cancer diagnosis and currently be on cancer-directed therapy with at least one of the following:
- •Chemotherapy: any anticancer drug to treat the cancer diagnosis, including immunotherapy.
- •Radiotherapy: any radiotherapy to treat the cancer diagnosis.
- •Surgery: any surgery to remove cancer including partial of total resections. Biopsies are not considered surgery.
- •Be greater than or equal to 2 months from diagnosis/initiation of therapy, whichever occurred later.
- •Be able to speak and read English
- •Have permission to participate from a member of the patient's primary oncology team.
- •Provision to sign and date the consent/assent form.
- •Active study participation of primary oncology clinician
- •Patient must have primary oncology care at Connecticut Children's Center for Cancer & Blood Disorders of Children's Hospital Los Angeles Cancer & Blood Disease Institute
排除标准
- •An individual who meets and of the following criteria will be excluded from participation in this study:
- •Not currently on cancer-directed therapy.
- •Unable to speak and read English.
- •Insufficient cognitive functioning to complete study measures (as determined by a member of the patient's primary oncology team)
- •Pediatric Oncology Clinicians
- •Be a pediatric oncology physician, clinical fellow, or advanced practice provider (including nurse practitioners and physician assistants) that provides clinical care for AYA patients with cancer
结局指标
主要结局
Feasibility of implementing the ReSPECT intervention.
时间窗: 2 months
Feasibility will be based on patient recruitment and completion of the intervention. The intervention will be considered feasible if AYA recruitment is greater than or equal to 60% and if greater than or equal to 80% of consented AYAs complete the intervention (retention). Intervention completion will be defined as AYA completion of the pre-visit questionnaire and post-intervention survey.
Acceptability of the ReSPECT intervention.
时间窗: 2 months
The intervention will be considered acceptable if greater than or equal to 70% of AYA and clinician participants rate ReSPECT as acceptable (average score of 4 or higher) on the Lyon Satisfaction Questionnaire, adapted for this study, which includes a 10-item satisfaction questionnaire where 1 is strongly disagree and 5 is strongly agree. Subjects will report via survey after the healthcare visit.
Usability of the ReSPECT intervention.
时间窗: 2 months
The intervention will be considered usable/sustainable if greater than or equal to 70% of AYA and clinician participants rate ReSPECT as usable (average score of 4 or higher) on the Usability/Sustainability of Intervention Scale, adapted for this study, on a 4-item usability questionnaire where 1 is strongly disagree and 5 is completely agree. Subjects will report via survey after the healthcare visit.
Perceived utility of the ReSPECT intervention.
时间窗: 2 months
Through qualitative interviews, participants will be asked for their perceptions on the impact of ReSPECT in promoting SRH communication in the outpatient clinic setting.
次要结局
- Comparison of patient reported SRH communication before and after intervention implementation.(2 months)
- Comparison of clinician reported SRH communication before and after intervention implementation.(2 months)
- Comparison of patient self-efficacy in discussing SRH topics with their oncology clinician before and after intervention implementation.(2 months)
- Comparison of clinician of self-efficacy in discussing SRH topics with their AYA patient before and after intervention implementation.(2 months)
- Comparison of patient- reported outcome expectancies related to discussing SRH topics with their oncology clinician before and after intervention implementation.(2 months)
- Intervention impact on decision-making.(2 months)
- Comparison of patient-reported distress/bother by SRH-related questions or concerns before and after the intervention.(2 months)
- Comparison of patient-reported engagement in sexual health risk behaviors before and after the intervention.(2 months)
- Comparison of patient-reported therapeutic alliance before and after the intervention.(2 months)