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临床试验/NCT00634257
NCT00634257已完成不适用

A Preliminary Study of Spirituality/Religiosity, Symptom Distress and Quality of Life Among Palliative Care Patients and Their Primary Caregivers

M.D. Anderson Cancer Center1 个研究点 分布在 1 个国家目标入组 193 人开始时间: 2008年2月22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
193
试验地点
1
主要终点
Association between self-rated spirituality/religiosity and coping strategies

研究概览

简要总结

Primary Objective:

-To examine the association between self-rated spirituality/religiosity and coping strategies (Brief RCOPE, Brief COPE, SBI-15R) among palliative care patients.

Secondary Objectives:

  • To examine the associations between self-rated spirituality/religiosity and physical (ESAS) and psychological symptom reports (HADS), and quality of life (FACIT-sp) among palliative care patients.
  • To examine the association between patient's self-reported spirituality/religiosity, and primary caregiver distress (HADS, PSQI, CQLS-C, caregiver self-assessment questionnaire, FACIT-sp).
  • To determine the frequency (self-rated spiritual pain scale when score is more or equal than 1 in the scale 0 to 10) and intensity of self-rated spiritual pain in the palliative care setting and to explore the association between spiritual pain, and negative religious coping (Brief RCOPE), physical (ESAS) and psychological symptoms (HADS), and primary caregiver distress (CQLS-C, caregiver self-assessment questionnaire).
  • To examine the association between primary caregivers' spirituality/religiosity (Appendix H, first question), religious coping strategies (Brief-RCOPE) and psychological and family/caregiver distress (HADS, PSQI, CQLS-C, caregiver self-assessment questionnaire), and caregivers' spiritual pain (Appendix F, second question).

详细描述

Questionnaires:

If you are found to be eligible to take part in this study and you agree to take part, you will complete 9 questionnaires.

The first 2 questionnaires ask about your demographic information (such as your education level and age) and the symptoms of cancer you may be experiencing.

The 6 other questionnaires ask questions about several subjects. You will be asked about your religious/spiritual beliefs, such as your way of coping with cancer and whether you have focused on religion/spirituality or other strategies in order to stop worrying. You will also be asked whether you feel religious/spiritual beliefs are important in your everyday life, how hopeful you may feel, and the level of spiritual pain you may feel. (Some people experience spiritual pain as a deep pain in the "soul" or "being" that is not physical pain.)

The last questionnaire asks about any symptoms of anxiety or depression you may feel. In total, these questionnaires should take about 40 minutes to complete.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

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) Advanced cancer patients seen in palliative care outpatient clinic and palliative care mobile team and inpatient unit at M.D. Anderson Cancer Center
  • (Patients) Patients aged 18 years or over
  • (Patients) Karnofsky performance status score of more than 40 at time of inclusion into study. (Patients with Karnofsky score less than 40 may not be able to complete the measures).
  • (Patients) Able to provide informed consent and comply with study procedures
  • (Caregivers) Spouse, first degree relative, or other person designated by the patient as providing direct assistance to the patient in his/her activities of daily living
  • (Caregivers) Having the patient's consent to be contacted.
  • (Caregivers) Caregiver is 18 years or over
  • (Caregivers) Able to provide informed consent and comply with study procedures
  • (Patients) only English-speaking, as determined by their ability to understand the informed consent and the assessment tools.
  • (Caregivers) only English-speaking, as determined by their ability to understand the informed consent and the assessment tools.
  • (Patients) Normal cognitive status as determined by the interviewer based on the ability to understand the nature of the study and consent process.

排除标准

  • 未提供

结局指标

主要结局

Association between self-rated spirituality/religiosity and coping strategies

时间窗: Questionnaires completed by patient/caregiver at second consult visit, estimate 40 minutes to finish forms.

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 (1)

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