NCT04040140

Brief Summary

The aims of this proposal are to (1) examine the feasibility of providing a training course of Auricular Point Acupressure (APA) for clinical oncology nurses who can integrate APA into real-world nursing care settings and (2) examine the effectiveness of APA on cancer-related pain (CRP) under the usual conditions.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2019

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 30, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 31, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

October 8, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2021

Completed
Last Updated

August 13, 2021

Status Verified

August 1, 2021

Enrollment Period

1.3 years

First QC Date

July 30, 2019

Last Update Submit

August 6, 2021

Conditions

Keywords

Auricular Point AcupressureCancer-related PainAcupressureNursing education

Outcome Measures

Primary Outcomes (3)

  • Change in Pain Intensity as assessed by the Brief Pain Inventory (BPI) short form

    Pain intensity in the last 24 hours (1) at its worst and (2) on average will both be measured on a scale of 0 (no pain) to 10 (pain as bad as you can imagine).

    Baseline (pre-treatment), APA Intervention (one session, 1 day), Follow-up (3 consecutive days after treatment, starting the first day treatment is given).

  • Change in Pain Interference as assessed by the Brief Pain Inventory (BPI) short form

    Pain interference with general activity, mood, walking ability, normal work, relationships with other people, sleep and enjoyment of life will be measured on a scale of 0 (does not interfere) to 10 (completely interferes).

    Baseline (pre-treatment), APA Intervention (one session, 1 day), Follow-up (3 consecutive days after treatment, starting the first day treatment is given).

  • Change in Dose of Analgesic Use

    Dose of analgesic use will be collected in electronic health record (EHR) as part of routine nursing assessments for patient care.

    Baseline (pre-treatment), APA Intervention (one session, 1 day), Follow-up (3 consecutive days after treatment, starting the first day treatment is given).

Secondary Outcomes (2)

  • Change in Fatigue as assessed by a 0 to 10 scale

    Baseline (pre-treatment), APA Intervention (one session, 1 day), Follow-up (3 consecutive days after treatment, starting the first day treatment is given).

  • Change in Quality of Sleep as assessed by a 0 to 10 scale

    Baseline (pre-treatment), APA Intervention (one session, 1 day), Follow-up (3 consecutive days after treatment, starting the first day treatment is given).

Study Arms (1)

APA Treatment

EXPERIMENTAL

Oncology patients with a pain rating of four or greater will receive APA treatment for patients' cancer-related pain. The ear points will be determined by the corresponding body points related to the patient's specific pain. Pain data will be tracked by electronic surveys and Electronic Health Records.

Other: APA Treatment

Interventions

Light touch using vaccaria seeds on corresponding ear points related to patient's pain.

APA Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Cancer patients with worst pain rated as 4 or more on a 0-10 numeric rating scale in the last 24 hours, which will use the EPIC pain scale
  • Able to read and write English
  • Able to apply pressure to the seeds taped to the ears. Patients with any cancer type will be eligible for this study so long as the patients are experiencing cancer-related pain
  • Owns a smartphone

You may not qualify if:

  • Is delirious
  • Has ear skin disease
  • Non-English speaker
  • Has latex allergy to the tape used for this study
  • Women who are pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231, United States

Location

Related Publications (1)

  • Van de Castle B, Lukkahatai N, Billing BL, Huang X, Wu H, Zhang J, Abdi S, Kameoka J, Smith TJ. Nurse-Administered Auricular Point Acupressure for Cancer-Related Pain. Integr Cancer Ther. 2023 Jan-Dec;22:15347354231198086. doi: 10.1177/15347354231198086.

MeSH Terms

Conditions

Cancer Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Chao Hsing Yeh, PhD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 30, 2019

First Posted

July 31, 2019

Study Start

October 8, 2019

Primary Completion

January 30, 2021

Study Completion

January 30, 2021

Last Updated

August 13, 2021

Record last verified: 2021-08

Locations