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Completed

NCT Number: NCT05139199

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.

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Key information

Conditions

Pancreatic Cancer Behavior Digestive System Diseases Digestive System Neoplasms Dyssomnias Endocrine Gland Neoplasms Endocrine System Diseases Fatigue Mental Disorders Motor Activity Neoplasms Neoplasms by Site Nervous System Diseases Pancreatic Diseases Pancreatic Neoplasms Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Taipei Veterans General Hospital

Taipei County, 112, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Auricular Point Acupressure group

Behavioral

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.

Primary outcomes

  1. Quality of Life (EORTC QLQ-C30 )

    Time frame: baseline

    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.

  2. Quality of Life (EORTC QLQ-C30 )

    Time frame: 1st 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.

  3. Quality of Life (EORTC QLQ-C30 )

    Time frame: 2nd 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.

  4. Quality of Life (EORTC QLQ-C30 )

    Time frame: 3rd 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.

  5. 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.

  6. Quality of Life (EORTC QLQ-PAN26 )

    Time frame: baseline

    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.

  7. Quality of Life (EORTC QLQ-PAN26 )

    Time frame: 1st 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.

  8. Quality of Life (EORTC QLQ-PAN26 )

    Time frame: 2nd 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.

  9. Quality of Life (EORTC QLQ-PAN26 )

    Time frame: 3rd 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.

  10. 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.

Secondary outcomes

  1. Fatigue(Brief Fatigue Inventory-Taiwan , BFI-T)

    Time frame: baseline

    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.

  2. Fatigue(Brief Fatigue Inventory-Taiwan , BFI-T)

    Time frame: 1st week after recruited

    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.

  3. Fatigue(Brief Fatigue Inventory-Taiwan , BFI-T)

    Time frame: 2nd week after recruited

    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.

  4. Fatigue(Brief Fatigue Inventory-Taiwan , BFI-T)

    Time frame: 3rd week after recruited

    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.

  5. Fatigue(Brief Fatigue Inventory-Taiwan , BFI-T)

    Time frame: 4th week after recruited

    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.

  6. Sleep quality(Pittsburgh Sleep Quality Index )

    Time frame: baseline

    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.

  7. Sleep quality(Pittsburgh Sleep Quality Index )

    Time frame: 1st week after recruited

    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.

  8. Sleep quality(Pittsburgh Sleep Quality Index )

    Time frame: 2nd week after recruited

    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.

  9. Sleep quality(Pittsburgh Sleep Quality Index )

    Time frame: 3rd week after recruited

    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.

  10. Sleep quality(Pittsburgh Sleep Quality Index )

    Time frame: 4th week after recruited

    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.

  11. Physical Activity(3-d Physical Record;Three-day activity record)

    Time frame: baseline

    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.

  12. Physical Activity(3-d Physical Record;Three-day activity record)

    Time frame: 1st week after recruited

    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.

  13. Physical Activity(3-d Physical Record;Three-day activity record)

    Time frame: 2nd week after recruited

    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.

  14. Physical Activity(3-d Physical Record;Three-day activity record)

    Time frame: 3rd week after recruited

    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.

  15. Physical Activity(3-d Physical Record;Three-day activity record)

    Time frame: 4th week after recruited

    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.

  16. Physical Activity(Exercise Counseling and Programming Preferences)

    Time frame: baseline

    Exercise preferences were assessed by questions related to exercise counseling and exercise programming.

Sponsors and collaborators

Lead sponsor

Taipei Veterans General Hospital, Taiwan

Other Gov

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 1, 2021
Registry last updated
Aug 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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