Telemedicine Pain Control Program for Teens Undergoing Treatment for Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Attrition rate
研究概览
简要总结
Pain in adolescents undergoing treatment for cancer is a common problem, often related to treatment or to the cancer itself. Due to increasing outpatient-based cancer treatment, the burden of care and pain management has shifted to the home environment. Yet, there are limited interventions that target the management of pain at home. Adolescence is marked by increased need for independence and social integration, both of which can be impaired by pain or fear of pain. To address unique needs during this developmental period, this study will test a telemedicine program to enhance pain knowledge and pain control strategies in adolescents ages 12-21 years who are undergoing treatment for cancer.
Fifty-six teens will be randomized to an intervention or wait-list control condition. Patients randomized to the waitlist control condition will receive the intervention following completion of the waitlist condition. The intervention will consist of four weekly 30-45 minute telemedicine (online via videoconferencing platform) sessions with a trained social work or psychology provider. Sessions will focus on pain psychoeducation, coping tools, communication, and stress management. Participants will complete online questionnaires assessing pain coping, pain management, and pain-related impairment at pre-intervention, post-intervention, and 1- and 2-month follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 12-21 years
- •At least two months post cancer diagnosis
- •Experienced pain in the past month as defined by at least one pain experience rated >3 on a 0-10 Numeric Rating Scale
- •Access to the internet for intervention sessions
- •Fluent in English (Given that the intervention will be delivered in English, all adolescents will need to be fluent in English to participate.)
排除标准
- •Significant cognitive impairment that may affect their ability to participate
结局指标
主要结局
Attrition rate
时间窗: Within 7 days of withdrawing from or completing the intervention
Determined by the percentage of participants who drop out of the study. An attrition rate of 20% or less will indicate feasibility.
Session attendance
时间窗: Within 7 days of withdrawing from or completing the intervention
Determined by the number of sessions that participants attend (out of 4 total sessions). To be considered feasible, 80% of participants must have completed at least 3 of the sessions within a 6-week period.
Acceptance (measured via 3 categorical multiple choice questions assessing acceptability, impressions, and helpfulness of intervention)
时间窗: Within 7 days of completing the intervention
Intervention will be deemed acceptable if at least 80% of participants rate each question an average of at least "4" ("Agree") on a 5-point scale anchored by "Strongly Disagree" and "Strongly Agree."
次要结局
- Change in pain coping behaviors as assessed by the Pain Coping Questionnaire (PCQ)(At study enrollment (pre-intervention) and between 4 and 6 weeks later (post-intervention for immediate group, post-waitlist period for waitlist group))
- Change in pain-related impairment as assessed by the PROMIS Pain Interference - Pediatric Short Form v2.0(At study enrollment (pre-intervention) and between 4 and 6 weeks later (post-intervention for immediate group, post-waitlist period for waitlist group))
研究者
Lonnie Zeltzer
Distinguished Professor
University of California, Los Angeles