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Trial record 3 of 26614 for:    DOLORES

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

This study is not yet open for participant recruitment.
Verified April 2017 by DERSHENG SUN, The Catholic University of Korea
Sponsor:
ClinicalTrials.gov Identifier:
NCT03117075
First Posted: April 17, 2017
Last Update Posted: April 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
DERSHENG SUN, The Catholic University of Korea
  Purpose
To compare the pain scales between clinician evaluated and reported with wearable device by patients.

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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The Efficacy of Pain Management With Self-reporting Pain Monitoring

Further study details as provided by DERSHENG SUN, The Catholic University of Korea:

Primary Outcome Measures:
  • Actual difference of pain scales [ Time Frame: 1 week after using wearable pain scale device - baseline and 1 week. ]
    comparing the pain scale assessed by wearable device and that assessed by physician when out patient clinic.


Estimated Enrollment: 68
Anticipated Study Start Date: May 15, 2017
Estimated Study Completion Date: April 14, 2018
Estimated Primary Completion Date: November 14, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03117075


Contacts
Contact: DERSHENG SUN, MD, PhD +82-31-820-3584 ds-sun@hanmail.net
Contact: HYESUNG WON, MD, PhD +82-31-820-5247 woncomet@catholic.ac.kr

Locations
Korea, Republic of
Daejeon St. Mary's Hospital, the Catholic University of Korea Active, not recruiting
Daejeon, Korea, Republic of
Seoul St. Mary's Hospital, the Catholic University of Korea Active, not recruiting
Seoul, Korea, Republic of, 06591
Sponsors and Collaborators
DERSHENG SUN
Investigators
Principal Investigator: YOONHO KO, MD, PhD Uijeongbu St. Mary's Hospital, the Catholic University of Korea
  More Information

Responsible Party: DERSHENG SUN, clinical assistant professor, The Catholic University of Korea
ClinicalTrials.gov Identifier: NCT03117075     History of Changes
Other Study ID Numbers: XC15EIMI0099KUD
First Submitted: January 19, 2016
First Posted: April 17, 2017
Last Update Posted: April 17, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by DERSHENG SUN, The Catholic University of Korea:
cancer pain, wearable device