NCT03117075

Brief Summary

To compare the pain scales between clinician evaluated and reported with wearable device by patients.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
68

participants targeted

Target at P25-P50 for not_applicable pain

Timeline
Completed

Started May 2017

Geographic Reach
1 country

2 active sites

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 19, 2016

Completed
1.2 years until next milestone

First Posted

Study publicly available on registry

April 17, 2017

Completed
28 days until next milestone

Study Start

First participant enrolled

May 15, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 14, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 14, 2018

Completed
Last Updated

April 17, 2017

Status Verified

April 1, 2017

Enrollment Period

6 months

First QC Date

January 19, 2016

Last Update Submit

April 12, 2017

Conditions

Pain

Keywords

cancer pain, wearable device

Outcome Measures

Primary Outcomes (1)

  • Actual difference of pain scales

    comparing the pain scale assessed by wearable device and that assessed by physician when out patient clinic.

    1 week after using wearable pain scale device - baseline and 1 week.

Study Arms (1)

Experimental

EXPERIMENTAL

using device for scoring pain scale, named "ANAPA®"

Device: using device for scoring pain scale, named "ANAPA®"

Interventions

using device for scoring pain scale, named "ANAPA®"DEVICE

wearable device for scoring pain scale

Experimental

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • over 20 year old
  • cancer pain with visual analog scale or numeric rating scale score \>/- 4
  • opioids candidates
  • with informed consent form

You may not qualify if:

  • life expectancy within 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Daejeon St. Mary's Hospital, the Catholic University of Korea

Daejeon, South Korea

Location

Seoul St. Mary's Hospital, the Catholic University of Korea

Seoul, 06591, South Korea

Location

MeSH Terms

Conditions

PainCancer Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • YOONHO KO, MD, PhD

    Uijeongbu St. Mary's Hospital, The Catholic University of Korea

    PRINCIPAL INVESTIGATOR

Central Study Contacts

DERSHENG SUN, MD, PhD

CONTACT

+82-31-820-3584ds-sun@hanmail.net

HYESUNG WON, MD, PhD

CONTACT

+82-31-820-5247woncomet@catholic.ac.kr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
clinical assistant professor

Study Record Dates

First Submitted

January 19, 2016

First Posted

April 17, 2017

Study Start

May 15, 2017

Primary Completion

November 14, 2017

Study Completion

April 14, 2018

Last Updated

April 17, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations

KR(2)