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临床试验/NCT03521765
NCT03521765已完成不适用

Occupational Therapy Interventions Based on Cancer Education on Quality of Life for Colorectal Cancer Survivors

National Cheng Kung University2 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2017年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
76
试验地点
2
主要终点
WHOQOL-BREF(the World Health Organization Quality of Life-BREF)

研究概览

简要总结

BACKGROUND:

Colorectal cancer (CRC) and its treatment affect CRC survivors' quality of life (QoL), emotional distress and activities of daily living (ADL). It is assumed that occupational therapy interventions based on cancer education may be a feasible approach.

Aim To examine the effect of using cancer education based on healthy lifestyle by occupational therapist on QoL, emotional distress, ADL and healthy lifestyle behaviors in CRC survivors.

Methods Participants with CRC were designed as a two-group controlled trial, and a single-blind randomized controlled trial was conducted. These participants were randomly assigned to either an OT intervention or a non-intervention group (in a 1:1 ratio). Those participants in the OT intervention group were given a consultation based on a CRC education handbook by an occupational therapist for discharge preparation and on 1-month, 3-month follow-up clinic; the non-intervention group participants were given a CRC education handbook (the same handbook) only for discharge preparation. The primary outcome was the change in QoL measured using WHOOQOL-BREF. Secondary outcomes were changes in emotional distress, ADL and healthy lifestyle behaviors. Outcomes were examined in baseline (discharge preparation), 1-month and 3-months follow-up clinic.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Participant)

入排标准

性别
All
接受健康志愿者

入选标准

  • (1) had a new diagnosis of CRC and were suffering from cancer for the first time, (2) had undergone CRC hospitalization (surgical) treatments, (3) were able to communicate in Mandarin or Taiwanese.

排除标准

  • Participants re-admitted within three months after discharge were excluded.

研究组 & 干预措施

OT intervention group

Experimental

The OT intervention group were given a consultation based on a CRC education handbook by an occupational therapist for discharge preparation and on 1-month, 3-month follow-up clinic.

干预措施: Cancer education (Other)

non-intervention group

No Intervention

The non-intervention group participants were given a CRC education handbook (the same handbook) only for discharge preparation.

结局指标

主要结局

WHOQOL-BREF(the World Health Organization Quality of Life-BREF)

时间窗: 10 min

The WHOQOL-BREF questionnaire is a self-assessment instrument, which is has been translated into several languages (The WHOQOL Group, 1998). It includes four domains: physical health, psychological health, social relationships, and environment.

次要结局

  • Brief Symptom Rating Scale (BSRS-5)(3 min)
  • Barthel Index (BI)(5 min)

研究者

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

Yang Shang-Yu

Mr.

National Cheng Kung University

研究点 (2)

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