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Pancreatic CancerNCT05139199

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

A study testing Auricular Point Acupressure group in people with Pancreatic Cancer, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 80 years
Conditions the study is for
Pancreatic Cancer
What is being tested?
Auricular Point Acupressure group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteTaiwan
Study dates
23 Feb 2022to 1 Aug 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Taiwan1 site
  • Taipei Veterans General Hospital

    Taipei County, 112

Other trials in Taiwan

About this study

Official title: 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.
Read the 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.

Being tested
Auricular Point Acupressure group
Keywords
Chemotherapy, Fatigue, Sleep Quality, Physical Activity, Quality of Life
Medical subject headings
Pancreatic Neoplasms, Fatigue, Sleep Initiation and Maintenance Disorders, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Auricular Point Acupressure groupBehavioural

    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.

Study groups in NCT05139199
Study groupRoleWhat they receive
Auricular Point AcupressureExperimentalA 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.
Receives: Behavioral: Auricular Point Acupressure group
usual-care groupNo interventionThese participants follows the standard Chemotherapy follow-up consisting of counseling by nurses and doctors.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: baseline

  2. 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.

    Measured: 1st week after recruited

  3. 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.

    Measured: 2nd week after recruited

  4. 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.

    Measured: 3rd week after recruited

  5. 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.

    Measured: 4th week after recruited

  6. 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.

    Measured: baseline

  7. 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.

    Measured: 1st week after recruited

  8. 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.

    Measured: 2nd week after recruited

  9. 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.

    Measured: 3rd week after recruited

  10. 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.

    Measured: 4th week after recruited

Secondary outcomes (16)
  1. 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.

    Measured: baseline

  2. 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.

    Measured: 1st week after recruited

  3. 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.

    Measured: 2nd week after recruited

  4. 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.

    Measured: 3rd week after recruited

  5. 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.

    Measured: 4th week after recruited

  6. 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.

    Measured: baseline

  7. 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.

    Measured: 1st week after recruited

  8. 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.

    Measured: 2nd week after recruited

  9. 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.

    Measured: 3rd week after recruited

  10. 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.

    Measured: 4th week after recruited

  11. 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.

    Measured: baseline

  12. 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.

    Measured: 1st week after recruited

  13. 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.

    Measured: 2nd week after recruited

  14. 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.

    Measured: 3rd week after recruited

  15. 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.

    Measured: 4th week after recruited

  16. Physical Activity(Exercise Counseling and Programming Preferences)

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

    Measured: baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Dec 2021
  2. Study start23 Feb 2022
  3. Primary completion1 Aug 2023
  4. Study completion1 Aug 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05139199
Sponsor's protocol ID
2021-12-005A
Status last verified
Aug 2022
First submitted
29 Jul 2021
Last updated
23 Aug 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices)

Publications

  • 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.

    PubMed 40179142

Questions about this trial

What is this clinical trial studying?

A study testing Auricular Point Acupressure group in people with Pancreatic Cancer, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Quality of Life (EORTC QLQ-C30 ) (time frame: baseline). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05139199, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2023.

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