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临床试验/NCT05139199
NCT05139199已完成不适用

Effectiveness of Auricular Point Acupressure in Improving Fatigue, Sleep Quality, Physical Activity and Quality of Life in Patients With Pancreatic Cancer Under Chemotherapy

Taipei Veterans General Hospital, Taiwan1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2022年2月23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
80
试验地点
1
主要终点
Quality of Life (EORTC QLQ-PAN26 )

研究概览

简要总结

This study will investigate the effectiveness of auricular point acupressure in improving fatigue,sleep quality,physical activity and quality of life in patients with pancreatic cancer under chemotherapy in taiwan.

Hypothesis:

  1. The fatigue in auricular point acupressure group is significant improving than usual-care group at 1st, 2nd, 3rd and 4th week.
  2. The sleep quality in auricular point acupressure group is significant improving than usual-care group at 1st, 2nd, 3rd and 4th week.
  3. The physical activity in auricular point acupressure group is significant improving than usual-care group at 1st, 2nd, 3rd and 4th week.
  4. The quality of life in auricular point acupressure group is significant improving than usual-care group at 1st, 2nd, 3rd and 4th week.

详细描述

This study will investigate the effectiveness of auricular point acupressure in improving fatigue,sleep quality,physical activity and quality of life in patients with pancreatic cancer under chemotherapy in taiwan.

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
20 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Paitent who aged over 20, with clear consciousness, is capable of communicating with Chinese, and is able to perform ear acupoints by himself/herself.
  • •Pancreatic Cancer patients who received chemotherapy in inpatient and outpatient department.
  • •The subject who agrees and is willing to participate in the research after explaining the purpose of the research.

排除标准

  • •Patient who is younger than 20 years old, illiterate, or is unable to cooperate with intervention measures.
  • •Patient who is not suitable for ear acupoint pressing after evaluated by the attending physician.

研究组 & 干预措施

Auricular Point Acupressure

Experimental

A 1-month regimen of auricular point acupressure, comprising usual-care of approximately 15-20 point pressing each time,3 times a day, seven times peer week.

干预措施: Auricular Point Acupressure group (Behavioral)

usual-care group

No Intervention

These participants follows the standard Chemotherapy follow-up consisting of counseling by nurses and doctors.

结局指标

主要结局

Quality of Life (EORTC QLQ-PAN26 )

时间窗: 4th week after recruited

This scale was evaluated by self-assessment of various clinical problems for a week.The EORTC QLQ-PAN26 consists of two subscales with 26 questions.The EORTC QLQ-PAN26 included two subscales:functioning scales (4 questions),symptom scales (22 questions). The reliability and validity of Cronbach'α was 0.69-0.97. About the functional scale, the higher the total score, the better the quality of life; the lower the score in the symptom scale, the better the quality of life.

Quality of Life (EORTC QLQ-C30 )

时间窗: 4th week after recruited

This scale was evaluated by self-assessment of various clinical problems for a week.The EORTC QLQ-C30 consists three subscales with 30 questions.The EORTC QLQ-C30 included three subscales: functioning scales (15questions), symptom scales (13 questions), and global health status (2questions). The reliability and validity of Cronbach'α was 0.52-0.89. About the functional scale and the global health status, the higher the total score, the better the quality of life; the lower the score in the symptom scale, the better the quality of life.

Quality of Life (EORTC QLQ-C30 )

时间窗: baseline

This scale was evaluated by self-assessment of various clinical problems for a week.The EORTC QLQ-C30 consists three subscales with 30 questions.The EORTC QLQ-C30 included three subscales: functioning scales (15questions), symptom scales (13 questions), and global health status (2questions). The reliability and validity of Cronbach'α was 0.52-0.89. About the functional scale and the global health status, the higher the total score, the better the quality of life; the lower the score in the symptom scale, the better the quality of life.

Quality of Life (EORTC QLQ-C30 )

时间窗: 1st week after recruited

This scale was evaluated by self-assessment of various clinical problems for a week.The EORTC QLQ-C30 consists three subscales with 30 questions.The EORTC QLQ-C30 included three subscales: functioning scales (15questions), symptom scales (13 questions), and global health status (2questions). The reliability and validity of Cronbach'α was 0.52-0.89. About the functional scale and the global health status, the higher the total score, the better the quality of life; the lower the score in the symptom scale, the better the quality of life.

Quality of Life (EORTC QLQ-C30 )

时间窗: 2nd week after recruited

This scale was evaluated by self-assessment of various clinical problems for a week.The EORTC QLQ-C30 consists three subscales with 30 questions.The EORTC QLQ-C30 included three subscales: functioning scales (15questions), symptom scales (13 questions), and global health status (2questions). The reliability and validity of Cronbach'α was 0.52-0.89. About the functional scale and the global health status, the higher the total score, the better the quality of life; the lower the score in the symptom scale, the better the quality of life.

Quality of Life (EORTC QLQ-C30 )

时间窗: 3rd week after recruited

This scale was evaluated by self-assessment of various clinical problems for a week.The EORTC QLQ-C30 consists three subscales with 30 questions.The EORTC QLQ-C30 included three subscales: functioning scales (15questions), symptom scales (13 questions), and global health status (2questions). The reliability and validity of Cronbach'α was 0.52-0.89. About the functional scale and the global health status, the higher the total score, the better the quality of life; the lower the score in the symptom scale, the better the quality of life.

Quality of Life (EORTC QLQ-PAN26 )

时间窗: baseline

This scale was evaluated by self-assessment of various clinical problems for a week.The EORTC QLQ-PAN26 consists of two subscales with 26 questions.The EORTC QLQ-PAN26 included two subscales:functioning scales (4 questions),symptom scales (22 questions). The reliability and validity of Cronbach'α was 0.69-0.97. About the functional scale, the higher the total score, the better the quality of life; the lower the score in the symptom scale, the better the quality of life.

Quality of Life (EORTC QLQ-PAN26 )

时间窗: 1st week after recruited

This scale was evaluated by self-assessment of various clinical problems for a week.The EORTC QLQ-PAN26 consists of two subscales with 26 questions.The EORTC QLQ-PAN26 included two subscales:functioning scales (4 questions),symptom scales (22 questions). The reliability and validity of Cronbach'α was 0.69-0.97. About the functional scale, the higher the total score, the better the quality of life; the lower the score in the symptom scale, the better the quality of life.

Quality of Life (EORTC QLQ-PAN26 )

时间窗: 2nd week after recruited

This scale was evaluated by self-assessment of various clinical problems for a week.The EORTC QLQ-PAN26 consists of two subscales with 26 questions.The EORTC QLQ-PAN26 included two subscales:functioning scales (4 questions),symptom scales (22 questions). The reliability and validity of Cronbach'α was 0.69-0.97. About the functional scale, the higher the total score, the better the quality of life; the lower the score in the symptom scale, the better the quality of life.

Quality of Life (EORTC QLQ-PAN26 )

时间窗: 3rd week after recruited

This scale was evaluated by self-assessment of various clinical problems for a week.The EORTC QLQ-PAN26 consists of two subscales with 26 questions.The EORTC QLQ-PAN26 included two subscales:functioning scales (4 questions),symptom scales (22 questions). The reliability and validity of Cronbach'α was 0.69-0.97. About the functional scale, the higher the total score, the better the quality of life; the lower the score in the symptom scale, the better the quality of life.

次要结局

  • Physical Activity(3-d Physical Record;Three-day activity record)(4th week after recruited)
  • Fatigue(Brief Fatigue Inventory-Taiwan , BFI-T)(4th week after recruited)
  • Sleep quality(Pittsburgh Sleep Quality Index )(4th week after recruited)
  • Physical Activity(Exercise Counseling and Programming Preferences)(baseline)
  • Fatigue(Brief Fatigue Inventory-Taiwan , BFI-T)(baseline)
  • Fatigue(Brief Fatigue Inventory-Taiwan , BFI-T)(1st week after recruited)
  • Fatigue(Brief Fatigue Inventory-Taiwan , BFI-T)(2nd week after recruited)
  • Fatigue(Brief Fatigue Inventory-Taiwan , BFI-T)(3rd week after recruited)
  • Sleep quality(Pittsburgh Sleep Quality Index )(baseline)
  • Sleep quality(Pittsburgh Sleep Quality Index )(1st week after recruited)
  • Sleep quality(Pittsburgh Sleep Quality Index )(2nd week after recruited)
  • Sleep quality(Pittsburgh Sleep Quality Index )(3rd week after recruited)
  • Physical Activity(3-d Physical Record;Three-day activity record)(baseline)
  • Physical Activity(3-d Physical Record;Three-day activity record)(1st week after recruited)
  • Physical Activity(3-d Physical Record;Three-day activity record)(2nd week after recruited)
  • Physical Activity(3-d Physical Record;Three-day activity record)(3rd week after recruited)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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