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临床试验/NCT03919864
NCT03919864已完成不适用

Caregiver Oncology Needs Evaluation Tool (CONNECT): A Technology-Based Intervention to Connect Lung Cancer Caregivers With Supportive Care Resources

Wake Forest University Health Sciences2 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2019年7月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
78
试验地点
2
主要终点
Accrual

研究概览

简要总结

The purpose of this research study is to evaluate a technology-based intervention, Caregiver Oncology Needs Evaluation Tool (CONNECT), which may increase lung cancer caregivers' knowledge about the benefits of supportive care resources, identify their unmet needs, and connect them with supportive care resources. The investigators will also determine their ability to recruit and keep patients and caregivers in the study.

详细描述

The long-term goal of this program of research is to improve supportive care delivery and lung cancer caregiver and patient well-being through a caregiver delivered intervention, Caregiver Oncology Needs Evaluation Tool (CONNECT). The investigators propose to evaluate a novel technology-based intervention, CONNECT, informed by theory with input from an advisory panel including a lung cancer caregiver and stakeholders. The purpose of CONNECT is to empower and educate caregivers about the benefits of supportive care resources and to systematically identify unmet needs and connect lung cancer caregivers with tailored supportive care resources. CONNECT is designed to be low cost and to capture the various resources offered in different oncology environments to support future adaptation and dissemination for heterogeneous healthcare settings.

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

入选标准

  • For Caregivers:
  • Caregivers must be providing some capacity of informal (unpaid) care for a patient meeting patient eligibility criteria. If a patient unexpectedly becomes deceased during the study period, caregivers will be allowed to continue participation in the assigned study arm and complete study assessments if they wish to.
  • Caregivers must be > 18 years of age, as this study is focused on the experience of adult patient-caregiver dyads.
  • For Patients:
  • Patients must have a current diagnosis of limited stage small cell or stage 1-4 nonsmall cell lung cancer.
  • Patients must be currently receiving or planning to receive treatment for their cancer at the time of enrollment. For patients receiving surgery, the eligibility timeframe will include 6 weeks following the date of surgery to account for the acute recovery period.
  • Patients must be ambulatory and up more than 50% of waking hours, as measured by an ECOG Performance Status rating of level 0, 1, or
  • Patients must be > 18 years of age, as this study is focused on the experience of adult patient-caregiver dyads.
  • Patients must be receiving some capacity of informal care from a caregiver meeting the above criteria. If the caregiver unexpectedly becomes deceased during the study period, the patient will be un-enrolled from this study as we are evaluating a caregiver-only delivered intervention.

排除标准

  • For Caregivers:
  • Caregivers cannot read/ communicate in English.
  • For Patients:
  • Patients who are post-treatment survivors at the time of study enrollment. For patients receiving surgery only, this includes the period beyond acute recovery (i.e. ≥ 7 weeks post-surgery).
  • Caregivers cannot read/ communicate in English.
  • Eligibility to participate in the study is conditional on participation of both the caregiver and patient.

结局指标

主要结局

Accrual

时间窗: Approximately 3 months

Number of caregivers who agreed to participate divided by the number of months of recruitment.

Participants Acceptability of the CONNECT Program Survey

时间窗: Approximately 3 months

A 10-item survey developed for study to assess how much caregivers liked different aspects of CONNECT.

Number of Eligible Participants

时间窗: Approximately 3 months

The number of eligible participants who agreed to participate in this study

Acceptability of CONNECT Program Interview

时间窗: Approximately 3 months

A 20-minute qualitative interview to explore factors associated with acceptability. During interviews, CONNECT elements will be reviewed and open-ended questions will be used to elicit feedback on functionality, strengths, and weaknesses of the e-tool. Interview recordings will be transcribed verbatim.

Retention of Participants

时间窗: Approximately 3 months

Number of participants who completed the T2 assessment divided by the number who agreed to participate

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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