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

NCT05139199 | Completed

• 1 other identifier: 2021-12-005A
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Conditions

Pancreatic Cancer

Keywords

Chemotherapy; Fatigue; Sleep Quality; Physical Activity; Quality of Life

Outcome Measures

Primary Outcomes (10)

• 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 Outcomes (16)

• Fatigue(Brief Fatigue Inventory-Taiwan , BFI-T)

  baseline

• Fatigue(Brief Fatigue Inventory-Taiwan , BFI-T)

  1st week after recruited

• Fatigue(Brief Fatigue Inventory-Taiwan , BFI-T)

  2nd week after recruited

• Fatigue(Brief Fatigue Inventory-Taiwan , BFI-T)

  3rd week after recruited

• Fatigue(Brief Fatigue Inventory-Taiwan , BFI-T)

  4th week after recruited

Study Arms (2)

Auricular Point Acupressure

EXPERIMENTAL

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

usual-care group

NO INTERVENTION

These participants follows the standard Chemotherapy follow-up consisting of counseling by nurses and doctors.

Interventions

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.

Auricular Point Acupressure

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead

Study Sites (1)

Taipei Veterans General Hospital

Taipei County, 112, Taiwan

Location

Related Publications (1)

• Gao WL, Chen HM, Liu CY, Huang TH, Li CP, Hsu SJ, Lee PC, Lee KC. Effects of Auricular Acupressure on Fatigue, Sleep Quality, Physical Activity, and Quality of Life in Pancreatic Cancer Patients Undergoing Chemotherapy: A Randomized Controlled Trial. Cancer Nurs. 2025 Apr 18. doi: 10.1097/NCC.0000000000001498. Online ahead of print.

  PMID: 40179142 DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms; Fatigue; Sleep Initiation and Maintenance Disorders; Motor Activity

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Behavior

Study Officials

• Hui-Mei Chen, PhD

  National Taipei University of Nursing and Health Sciences

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2021
• First Posted: December 1, 2021
• Study Start: February 23, 2022
• Primary Completion: August 1, 2023
• Study Completion: August 1, 2023
• Last Updated: August 23, 2023

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 12 months and ending 36 months following article publication
• Access Criteria: Researchers who provide a methodologically sound proposal and receive the authors consent.

Locations

TW (1)