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

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

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.

Study Overview

• Status: Completed
• Conditions: Pancreatic Cancer
• Intervention / Treatment: Behavioral: Auricular Point Acupressure group

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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei county, Taiwan, 112
    • Taipei Veterans General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Auricular Point Acupressure; 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.	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.
No Intervention: usual-care group; These participants follows the standard Chemotherapy follow-up consisting of counseling by nurses and doctors.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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'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.	baseline
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'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.	1st week after recruited
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'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.	2nd week after recruited
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'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.	3rd week after recruited
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'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.	4th week after recruited
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'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.	baseline
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'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.	1st week after recruited
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'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.	2nd week after recruited
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'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.	3rd week after recruited
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'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.	4th week after recruited

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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'α was 0.83. About lower scores the higher the total score, the better the quality of sleep.	baseline
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'α was 0.83. About lower scores the higher the total score, the better the quality of sleep.	1st week after recruited
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'α was 0.83. About lower scores the higher the total score, the better the quality of sleep.	2nd week after recruited
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'α was 0.83. About lower scores the higher the total score, the better the quality of sleep.	3rd week after recruited
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'α was 0.83. About lower scores the higher the total score, the better the quality of sleep.	4th week after recruited
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
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
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
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
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
Physical Activity(Exercise Counseling and Programming Preferences)	Exercise preferences were assessed by questions related to exercise counseling and exercise programming.	baseline

Collaborators and Investigators

• Sponsor: Taipei Veterans General Hospital, Taiwan
• Investigators: Study Chair: Hui-Mei Chen, PhD, National Taipei University of Nursing and Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): February 23, 2022
• Primary Completion (Actual): August 1, 2023
• Study Completion (Actual): August 1, 2023

Study Registration Dates

• First Submitted: July 29, 2021
• First Submitted That Met QC Criteria: November 24, 2021
• First Posted (Actual): December 1, 2021

Study Record Updates

• Last Update Posted (Actual): August 23, 2023
• Last Update Submitted That Met QC Criteria: August 21, 2023
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Physical Activity; Quality of Life; Fatigue; Sleep Quality; Chemotherapy
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms
• Other Study ID Numbers: 2021-12-005A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices)
• IPD Sharing Time Frame: Beginning 12 months and ending 36 months following article publication
• IPD Sharing Access Criteria: Researchers who provide a methodologically sound proposal and receive the authors consent.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No