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

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

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

Conditions
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Pancreatic Cancer

Intervention / Treatment
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* Behavioral: Auricular Point Acupressure group


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chemotherapy, Fatigue, Sleep Quality, Physical Activity, Quality of Life