The Efficacy of Pain Management With Self-reporting Pain... | NCT03117075

Studies
The Efficacy of Pain Management With Self-reporting Pain Monitoring System in Cancer Patient

NCT03117075

Sponsor

DERSHENG SUN

Status

Unknown status

Last Update Posted

Apr 17, 2017Actual

Enrollment

68Estimated

Phase

Not Applicable

Conditions

Pain

Interventions

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

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 15, 2017Estimated

Primary Completion Date

Nov 14, 2017Estimated

Completion Date

Apr 14, 2018Estimated

First Submitted Date

Jan 19, 2016

First Submission Date that Met QC Criteria

Apr 12, 2017

First Posted Date

Apr 17, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 12, 2017

Last Update Posted Date

Apr 17, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

68Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Experimental	Experimental	using device for scoring pain scale, named "ANAPA®"	Device: using device for scoring pain scale, named "ANAPA®"

Interventions

Name	Type	Description	Arm Group Labels	Other Names
using device for scoring pain scale, named "ANAPA®"	Device	wearable device for scoring pain scale	Experimental

Outcomes Module

Primary Outcomes

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.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
DERSHENG SUN, MD, PhD	Contact	+82-31-820-3584		ds-sun@hanmail.net
HYESUNG WON, MD, PhD	Contact	+82-31-820-5247		woncomet@catholic.ac.kr

Overall Officials

Name	Affiliation	Role
YOONHO KO, MD, PhD	Uijeongbu St. Mary's Hospital, The Catholic University of Korea	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Daejeon St. Mary's Hospital, the Catholic University of Korea		Daejeon			South Korea
Seoul St. Mary's Hospital, the Catholic University of Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010146	Pain
D000072716	Cancer Pain

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided