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临床试验/NCT05525299
NCT05525299招募中不适用

The Effects of a Reminiscence-Based Life Review on Copying With Existential Suffering Among Older Cancer Survivors With Cognitive Impairment

The University of Hong Kong1 个研究点 分布在 1 个国家目标入组 116 人开始时间: 2022年10月30日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
116
试验地点
1
主要终点
Purpose in life

研究概览

简要总结

Target Issue:

Cognitive impairment in older cancer survivors is highly prevalent and the co-existing neuro-psychiatric symptoms, particularly depression, would further complicate the psychosocial consequence of existential suffering. However, no reminiscence-based interventions are specifically developed for older people with cancer have been developed and evaluated.

Target Population:

Cancer survivors aged 65 years old and above with a mild cognitive impairment identified by the HK-MoCA 5-Min Protocol cognitive assessment.

Intervention:

This research project aims to implement a brief reminiscence-based intervention that includes six reminiscence chatting sessions among older cancer survivors. The proposed reminiscence-based intervention has great potential to provide psychological and spiritual care as well as comfort to those who are weak, aged and are in need of assistance.

Study Objectives:

  1. To evaluate the effect of a reminiscence-based life review intervention on copying with existential suffering including meaning of life (primary outcome), cognitive function, psychological distress and social support (secondary outcomes) in older cancer survivors
  2. To explore older cancer survivors' experience of the intervention regarding the impact of the intervention on their existential suffering

Study Method:

The investigator will recruit 116 voluntary elder patients from the outpatient oncology clinics of the Queen Mary Hospital to participate in the study. They will be individually randomized at a 1:1 ratio to receive usual care or the brief reminiscence-based intervention at home. Outcomes will be assessed at baseline (T0), post-intervention (T1), and 6-week follow-up (T2). A qualitative interview regarding the feedback on the intervention will be undertaken only in the intervention group.

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
Single (Outcomes Assessor)

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aged ≥ 65 years
  • Diagnosed with stage I-III non-metastatic cancer
  • Completed primary treatment with curative intent (surgery, chemotherapy, and/or radiation therapy) 6 months to 5 years prior to baseline assessments with no recurrence or occurrence of additional cancers
  • identified as mild cognitive impairment by the HK-MoCA 5-Min Protocol cognitive assessment (≤ 7th age and education corrected percentile cutoff score)

排除标准

  • Inadequate written and verbal Cantonese and/or English comprehension for study activities
  • Diagnosed with dementia

结局指标

主要结局

Purpose in life

时间窗: up to 6 weeks

The purpose in life will be assessed by the Purpose in Life (PIL) Test developed by Crumbaugh and Maholick (1964), which considers the meaning of life as unique and personal for each individual and as changing throughout the life cycle. The PIL test consists of 20 items that saturate four dimensions: perception of meaning (motives, reasons, and valuation of living life); experience of meaning (perception of one's own life and daily life as full of good things); goals and tasks (goals linked to concrete actions in life and perception of personal responsibility) and dialectic/destiny and freedom (tension between destiny and freedom and coping with death as an uncontrollable, unpredictable, and inevitable event).

次要结局

  • Psychological distress(up to 6 weeks)
  • Perceived social support(up to 6 weeks)
  • Cognitive function(up to 6 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mu-Hsing Ho

Research Assistant Professor

The University of Hong Kong

研究点 (1)

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