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2022-02-23
2023-08-01
2023-08-01
80
NCT05139199
Taipei Veterans General Hospital, Taiwan
Taipei Veterans General Hospital, Taiwan
INTERVENTIONAL
Effectiveness of Auricular Point Acupressure in Improving Quality of Life in Patients With Pancreatic Cancer
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.
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2021-07-29 | N/A | 2023-08-21 |
2021-11-24 | N/A | 2023-08-23 |
2021-12-01 | N/A | 2022-08 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Supportive Care
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
Single
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
|
| NO_INTERVENTION: usual-care group These participants follows the standard Chemotherapy follow-up consisting of counseling by nurses and doctors. |
| Primary Outcome Measures | 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 | 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 |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
20 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
