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临床试验/NCT06282471
NCT06282471撤回不适用

Expressive Writing (EW) and Self-Guided Problem-Solving Therapy (PST) in Cancer Survivors and Caregivers

Virginia Commonwealth University0 个研究点目标入组 50 人开始时间: 2024年2月21日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
入组人数
50
主要终点
Study Retention

研究概览

简要总结

To assess the feasibility and acceptability of expressive writing + problem solving therapy (EW+PST) among cancer survivors and informal caregivers

详细描述

This is a single-arm proof-of-concept behavioral clinical trial of a self-guided expressive writing and problem-solving therapy intervention for adult cancer survivors and adult informal caregivers thereof

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

  • Cancer diagnosis of any type OR informal caregiver (family member, friend, and/or spouse who provides the majority of caregiving) of someone with cancer
  • Patient of Virginia Commonwealth University (VCU) Massey Cancer Center OR informal caregiver (family member, friend, and/or spouse) of a VCU Massey Cancer Center patient

排除标准

  • Physical inability to write
  • Non-English speaker/writer
  • Inability to consent to study participation

结局指标

主要结局

Study Retention

时间窗: Week 6

Study retention will be analyzed as the number of participants completing the 6-week questionnaires

Consent Rate

时间窗: Day 1

Number of eligible individuals who choose to enroll in the study over the total number of eligible individuals.

Patient Satisfaction Questionnaire

时间窗: Baseline, Week 6

The number of participants that are satisfied with the intervention. Participants will be asked about their satisfaction with the program including perceived efficacy and suggestions for improvement

Completed Journal Entries

时间窗: Week 6

Number of completed journal entries will be tabulated from returned participant journals.

次要结局

  • Change in Patient Health Questionnaire-8 (PHQ-8) Score from 0 to 6 Weeks(Baseline, Week 6)
  • Change in Multidimensional Scale of Perceived Social Support (MSPSS) Score from 0 to 6 Weeks(Baseline, Week 6)
  • Change in Post Traumatic Growth Inventory (PTGI) Score from 0 to 6 weeks(Baseline, Week 6)
  • Change in Perceived Stress Scale-10 item (PSS-10) Score from 0 to 6 Weeks(Baseline, Week 6)
  • Change in New General Self-Efficacy Scale (GSES-N) Score from 0 to 6 Weeks(Baseline, Week 6)
  • Change in EORTC Quality of Life Core Scale (EORTC QLQ-30) Score from 0 to 6 Weeks(Baseline, Week 6)
  • Change in European Organization for the Research and Treatment of Life Questionnaire (EORTC QLQ-30) Score from 0 to 6 weeks(Baseline, Week 6)
  • Change in Family Environment Scale-Revised (FES-R) Score from 0 to 6 Weeks(Baseline, Week 6)
  • Change in Cancer Communication Assessment Tool for Patients and Families (CCAT-PF) Score from 0 to 6 Weeks(Baseline, Week 6)
  • Change in Caregiver Burden Scale (CBS) Score from 0 to 6 Weeks(Baseline, Week 6)

研究者

申办方类型
Other
责任方
Sponsor

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