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临床试验/NCT06038604
NCT06038604已完成不适用

Psychosocial Support Program for Patients With Glioblastoma and Their Family Caregivers

Duke University2 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2023年11月3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
11
试验地点
2
主要终点
Participants' satisfaction with treatment

研究概览

简要总结

The goal of the study is to conduct a pilot test of the psychosocial support intervention with family caregivers and/or patients coping with glioblastoma.

详细描述

The specific aims of this study is to pilot test the psychosocial support program for patients with glioblastoma and/or their family caregivers. The investigators will recruit patient-caregiver dyads for the psychosocial support intervention; participants will have the choice whether to take part in the intervention as a dyad or individually given the variability of symptoms and progression of glioblastoma. The investigators will examine acceptability and feasibility of the intervention and examine whether participation in the program can help reduce distress and improve quality of life.

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

  • Patients who self-report a diagnosis of glioblastoma
  • Age >18 years
  • English Speaking

排除标准

  • Lacks capacity for interview or is unable to provide informed consent
  • Visual or hearing impairments or severe behavioral problems that preclude participation
  • Too sick to participate
  • For caregivers:
  • Inclusion Criteria:
  • Age >18 years
  • English Speaking
  • Exclusion Criteria:
  • Lacks capacity for interview or is unable to provide informed consent
  • Visual or hearing impairments or severe behavioral problems that preclude participation
  • Too sick to participate

结局指标

主要结局

Participants' satisfaction with treatment

时间窗: End of study (4-months)

Overall satisfaction rating for the psychosocial intervention with 70% of patients and caregivers reporting satisfaction. The Evaluation of Services measure will take the average of the item scores (0-4), with a mean of 3.0/4.0 as an indication of satisfaction

Number of participants who complete study participation

时间窗: End of study (4-months)

Completion of sessions by 70% of participants across a four-month period

Number of participants who complete post-intervention assessment

时间窗: End of study (4-months)

Completion of assessments by 70% of participants across a four-month period

次要结局

  • Caregiving efficacy as measured by the caregiver inventory(Baseline; Post-intervention follow up (up to 4 months))
  • General distress as measured by the Distress Thermometer(Baseline; Post-intervention follow up (up to 4 months))
  • Functional well-being as measured by the Functional Assessment of Cancer Therapy - General (FACT-G)(Baseline; Post-intervention follow up (up to 4 months))
  • Anxiety and depressive symptoms as measured by the Hospital Anxiety and Depression Scale (HADS)(Baseline; Post-intervention follow up (up to 4 months))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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