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Clinical Trials/NCT05139199
NCT05139199
Completed
Not Applicable

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 site in 1 country80 target enrollmentFebruary 23, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pancreatic Cancer
Sponsor
Taipei Veterans General Hospital, Taiwan
Enrollment
80
Locations
1
Primary Endpoint
Quality of Life (EORTC QLQ-PAN26 )
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
February 23, 2022
End Date
August 1, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

Quality of Life (EORTC QLQ-PAN26 )

Time Frame: 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 )

Time Frame: 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.

Secondary Outcomes

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

Study Sites (1)

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