The Efficacy of Pain Management With Self-reporting Pain Monitoring System in Cancer Patient (pain)

The Efficacy of Pain Management With Self-reporting Pain Monitoring

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

Study Overview

• Status: Unknown
• Conditions: Pain
• Intervention / Treatment: Device: using device for scoring pain scale, named "ANAPA®"

Detailed Description

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

• Study Type: Interventional
• Enrollment (Anticipated): 68
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: DERSHENG SUN, MD, PhD; Phone Number: +82-31-820-3584; Email: ds-sun@hanmail.net
• Study Contact Backup: Name: HYESUNG WON, MD, PhD; Phone Number: +82-31-820-5247; Email: woncomet@catholic.ac.kr

Study Locations

• Korea, Republic of
  • Daejeon, Korea, Republic of
    • Daejeon St. Mary's Hospital, the Catholic University of Korea
  • Seoul, Korea, Republic of, 06591
    • Seoul St. Mary's Hospital, The Catholic University of Korea

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• life expectancy within 3 months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental; using device for scoring pain scale, named "ANAPA®"	Device: using device for scoring pain scale, named "ANAPA®"; wearable device for scoring pain scale

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: DERSHENG SUN
• Investigators: Principal Investigator: YOONHO KO, MD, PhD, Uijeongbu St. Mary's Hospital, The Catholic University of Korea

Study record dates

Study Major Dates

• Study Start (Anticipated): May 15, 2017
• Primary Completion (Anticipated): November 14, 2017
• Study Completion (Anticipated): April 14, 2018

Study Registration Dates

• First Submitted: January 19, 2016
• First Submitted That Met QC Criteria: April 12, 2017
• First Posted (Actual): April 17, 2017

Study Record Updates

• Last Update Posted (Actual): April 17, 2017
• Last Update Submitted That Met QC Criteria: April 12, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: cancer pain, wearable device
• Other Study ID Numbers: XC15EIMI0099KUD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No