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临床试验/NCT05064787
NCT05064787已完成不适用

Evaluating the Feasibility of a Digital Health Coaching Program for Individuals Following CAR T Therapy

Pack Health2 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2022年3月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
45
试验地点
2
主要终点
Feasibility of the intervention

研究概览

简要总结

The aim of this study is to evaluate the feasibility of a digital health coaching program for, and to describe quality of life of, individuals in the 6 months following chimeric antigen receptor (CAR) T cell therapy. Up to 50 English-speaking individuals aged 18 and older who are to receive treatment with a CAR T cell therapy will be enrolled, all at The University of Texas MD Anderson Cancer Center. Participants must have internet access via smart phone, tablet, a computer, or another device with the capacity to receive calls, texts, or e-mails, as well as the electronic study assessments and will be excluded if they are unable to provide informed consent or have a prognosis of 6 months or less.

Consented participants will be enrolled in a 6-month digital health coaching program delivered via weekly calls from a Health Advisor coupled with the digital delivery of content. The program focuses on identification and escalation of treatment-related toxicity, communication with providers, and physical and psychosocial health following treatment. Health related quality of life (HRQoL) will be assessed with the Functional Assessment of Cancer Therapy-Lymphoma (FACT-L), health self-efficacy will be assessed by the Cancer Behavior Inventory-Brief (CBI-B), physical and mental health outcomes will be measured by the National Institutes of Health (NIH) Patient Reported Outcomes Measurement Information System (PROMIS) Global Health 10. Patient experience in managing CAR T specific care will be assessed with a 5-item questionnaire developed specifically for use in this study, focused on participants' confidence in understanding, identifying and managing symptoms, and communicating with providers. Study outcomes will contribute to knowledge about if and how a digital health intervention may be used to support individuals post-CAR T cell therapy.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults aged 18 and older
  • Able to read, speak and consent in English
  • Confirmed treatment with any commercially available or investigational CAR T cell therapy.
  • Internet access via smart phone, tablet, a computer, or another device with the capacity to receive calls, texts, or e-mails, as well as the electronic study assessments.
  • Ability to engage in physical activity as evidenced by an Eastern Cooperative Oncology Group (ECOG) performance status score of less than or equal to 2

排除标准

  • Individuals who are terminally ill, defined as individuals identified by their physician as likely having 6 months or less to live, or those individuals transitioned to comfort measures only (meaning only supportive care measures without curative focused treatment)
  • Individuals for whom there is documentation of inability to provide consent in the medical record.
  • Non-English speaking/reading individuals.

结局指标

主要结局

Feasibility of the intervention

时间窗: Through study completion, at month 6

Feasibility is defined as a retention rate in the digital health coaching program greater than or equal to 60% at month 6

Acceptability

时间窗: Through study completion, at month 6

Acceptability will be assessed with a 3-item evaluation to address engagement, usefulness and relevance

次要结局

  • Cancer Behavior Inventory (CBI-B)(Enrollment, Months 1, 3, 6)
  • National Institutes of Health (NIH) Patient Reported Outcomes Measurement Information System (PROMIS) Global Health 10(Enrollment, Month 6)
  • Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym)(Enrollment, Months 1, 3, 6)
  • Subjective Assessment of CAR T Management(Enrollment, Months 1, 3, 6)

研究者

发起方
Pack Health
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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