Effectiveness of Auricular Point Acupressure in Improving Quality of Life in Patients With Pancreatic Cancer

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05139199
• Other study ID #: 2021-12-005A
• Status: Completed
• Phase: N/A
• Start date: February 23, 2022
• Est. completion date: August 1, 2023

Study information

• Verified date: August 2022
• Source: Taipei Veterans General Hospital, Taiwan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: August 1, 2023
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Paitent who aged over 20, with clear consciousness, is capable of communicating with Chinese, and is able to perform ear acupoints by himself/herself.

2. Pancreatic Cancer patients who received chemotherapy in inpatient and outpatient department.

3. The subject who agrees and is willing to participate in the research after explaining the purpose of the research.

Exclusion Criteria:

1. Patient who is younger than 20 years old, illiterate, or is unable to cooperate with intervention measures.

2. Patient who is not suitable for ear acupoint pressing after evaluated by the attending physician.

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Behavioral:
• Auricular Point Acupressure group
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.

Locations

Country	Name	City	State
Taiwan	Taipei Veterans General Hospital	Taipei county

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Veterans General Hospital, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of Life (EORTC QLQ-C30 )	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'a 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.	baseline
Primary	Quality of Life (EORTC QLQ-C30 )	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'a 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.	1st week after recruited
Primary	Quality of Life (EORTC QLQ-C30 )	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'a 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.	2nd week after recruited
Primary	Quality of Life (EORTC QLQ-C30 )	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'a 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.	3rd week after recruited
Primary	Quality of Life (EORTC QLQ-C30 )	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'a 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.	4th week after recruited
Primary	Quality of Life (EORTC QLQ-PAN26 )	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'a 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.	baseline
Primary	Quality of Life (EORTC QLQ-PAN26 )	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'a 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.	1st week after recruited
Primary	Quality of Life (EORTC QLQ-PAN26 )	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'a 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.	2nd week after recruited
Primary	Quality of Life (EORTC QLQ-PAN26 )	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'a 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.	3rd week after recruited
Primary	Quality of Life (EORTC QLQ-PAN26 )	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'a 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.	4th week after recruited
Secondary	Fatigue(Brief Fatigue Inventory-Taiwan , BFI-T)	This scale was evaluated by self-assessment of various clinical problems for 24 hours.The BFI-T have 9 questions. Retest reliability was 0.89-0.91.	baseline
Secondary	Fatigue(Brief Fatigue Inventory-Taiwan , BFI-T)	This scale was evaluated by self-assessment of various clinical problems for 24 hours.The BFI-T have 9 questions. Retest reliability was 0.89-0.91.	1st week after recruited
Secondary	Fatigue(Brief Fatigue Inventory-Taiwan , BFI-T)	This scale was evaluated by self-assessment of various clinical problems for 24 hours.The BFI-T have 9 questions. Retest reliability was 0.89-0.91.	2nd week after recruited
Secondary	Fatigue(Brief Fatigue Inventory-Taiwan , BFI-T)	This scale was evaluated by self-assessment of various clinical problems for 24 hours.The BFI-T have 9 questions. Retest reliability was 0.89-0.91.	3rd week after recruited
Secondary	Fatigue(Brief Fatigue Inventory-Taiwan , BFI-T)	This scale was evaluated by self-assessment of various clinical problems for 24 hours.The BFI-T have 9 questions. Retest reliability was 0.89-0.91.	4th week after recruited
Secondary	Sleep quality(Pittsburgh Sleep Quality Index )	The Pittsburgh Sleep Quality Index (PSQI) consists of 19 self-rated questions and 5 questions rated by the bed partner or roommate. The reliability and validity of Cronbach'a was 0.83. About lower scores the higher the total score, the better the quality of sleep.	baseline
Secondary	Sleep quality(Pittsburgh Sleep Quality Index )	The Pittsburgh Sleep Quality Index (PSQI) consists of 19 self-rated questions and 5 questions rated by the bed partner or roommate. The reliability and validity of Cronbach'a was 0.83. About lower scores the higher the total score, the better the quality of sleep.	1st week after recruited
Secondary	Sleep quality(Pittsburgh Sleep Quality Index )	The Pittsburgh Sleep Quality Index (PSQI) consists of 19 self-rated questions and 5 questions rated by the bed partner or roommate. The reliability and validity of Cronbach'a was 0.83. About lower scores the higher the total score, the better the quality of sleep.	2nd week after recruited
Secondary	Sleep quality(Pittsburgh Sleep Quality Index )	The Pittsburgh Sleep Quality Index (PSQI) consists of 19 self-rated questions and 5 questions rated by the bed partner or roommate. The reliability and validity of Cronbach'a was 0.83. About lower scores the higher the total score, the better the quality of sleep.	3rd week after recruited
Secondary	Sleep quality(Pittsburgh Sleep Quality Index )	The Pittsburgh Sleep Quality Index (PSQI) consists of 19 self-rated questions and 5 questions rated by the bed partner or roommate. The reliability and validity of Cronbach'a was 0.83. About lower scores the higher the total score, the better the quality of sleep.	4th week after recruited
Secondary	Physical Activity(3-d Physical Record;Three-day activity record)	The design to estimate energy expenditure. Two days could be any day of the week, but the 3rd day had to be either a Saturday or a Sunday. A day was divided into 96 periods of 15 mins each, energy expenditure was qualified on a scale from 1 to 9.	baseline
Secondary	Physical Activity(3-d Physical Record;Three-day activity record)	The design to estimate energy expenditure. Two days could be any day of the week, but the 3rd day had to be either a Saturday or a Sunday. A day was divided into 96 periods of 15 mins each, energy expenditure was qualified on a scale from 1 to 9.	1st week after recruited
Secondary	Physical Activity(3-d Physical Record;Three-day activity record)	The design to estimate energy expenditure. Two days could be any day of the week, but the 3rd day had to be either a Saturday or a Sunday. A day was divided into 96 periods of 15 mins each, energy expenditure was qualified on a scale from 1 to 9.	2nd week after recruited
Secondary	Physical Activity(3-d Physical Record;Three-day activity record)	The design to estimate energy expenditure. Two days could be any day of the week, but the 3rd day had to be either a Saturday or a Sunday. A day was divided into 96 periods of 15 mins each, energy expenditure was qualified on a scale from 1 to 9.	3rd week after recruited
Secondary	Physical Activity(3-d Physical Record;Three-day activity record)	The design to estimate energy expenditure. Two days could be any day of the week, but the 3rd day had to be either a Saturday or a Sunday. A day was divided into 96 periods of 15 mins each, energy expenditure was qualified on a scale from 1 to 9.	4th week after recruited
Secondary	Physical Activity(Exercise Counseling and Programming Preferences)	Exercise preferences were assessed by questions related to exercise counseling and exercise programming.	baseline