NCT02765269

Brief Summary

The purpose of this study is to determine whether the Intelligent Pain Management System (IPMS) could make recording and interfering pain timely among cancer patients with pain. The system's usability, feasibility, compliance, and satisfaction will also be assessed.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable pain

Timeline
Completed

Started May 2016

Geographic Reach
1 country

1 active site

Status
completed

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

April 25, 2016

Completed
6 days until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 6, 2016

Completed
6 months until next milestone

Results Posted

Study results publicly available

October 21, 2016

Completed
Last Updated

December 5, 2016

Status Verified

July 1, 2016

Enrollment Period

Same day

First QC Date

April 25, 2016

Results QC Date

July 13, 2016

Last Update Submit

October 23, 2016

Conditions

PainNeoplasms

Keywords

cancer painmobile applications

Outcome Measures

Primary Outcomes (1)

  • Feasibility of Mobile Application Assessed by Observing the Number of Daily Pain Assessments Recorded Among Patients

    The primary objective is to demonstrate that this mobile application is feasible by observing the numbers of daily pain assessment among patients.

    2 weeks

Secondary Outcomes (3)

  • Pain Management

    2 weeks

  • Users' Satisfaction (Questionnaire)

    2 weeks

  • Karnofsky Performance Score Evaluation

    2 weeks

Study Arms (2)

IPMS group

EXPERIMENTAL

Cancer patients with pain are asked to use the Intelligent Pain Management System as much as possible to record the degree and location of pain at least once every day. Through assessments of these pain record, physicians could give the patients appropriate advice.

Device: Intelligent Pain Management System

Control group

NO INTERVENTION

The control group are communicated through conventional method such as telephone calls or door-to-door visit to collect the pain assessment to guide doctors' therapy.

Interventions

Intelligent Pain Management SystemDEVICE

A mobile phone application which can record the pain the cancer patients have and can deliver these records to doctors in order that doctors give patients prescriptions promptly.

Also known as: IPMS
IPMS group

Eligibility Criteria

Age45 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • the patient was able to read Chinese and use smart phones;
  • the patient was diagnosed with cancer and has self-reported cancer pain within a month prior to the study;
  • the patient was being seen on a regular basis by the oncology team;
  • the patient was under standard analgesia treatments;
  • the patient was estimated to have over 3 months survival time.

You may not qualify if:

  • the patients who self-reported to have severe cognitive impairments or major comorbid illnesses that would interfere with pain assessment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xinhua Translational Institute for Cancer Pain, Shanghai

Shanghai, Shanghai Municipality, China

Location

Related Publications (1)

  • Sun Y, Jiang F, Gu JJ, Wang YK, Hua H, Li J, Cheng Z, Liao Z, Huang Q, Hu W, Ding G. Development and Testing of an Intelligent Pain Management System (IPMS) on Mobile Phones Through a Randomized Trial Among Chinese Cancer Patients: A New Approach in Cancer Pain Management. JMIR Mhealth Uhealth. 2017 Jul 25;5(7):e108. doi: 10.2196/mhealth.7178.

    PMID: 28743681DERIVED

MeSH Terms

Conditions

PainNeoplasmsCancer Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Gang Ding
Organization
Xinhua Translational Institute for Cancer Pain, Shanghai
021-69691540

Study Officials

  • Gang Ding

    Xinhua Hospital Affliated to Shanghai Jiao Tong University School of Medicine, Chongming Branch

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 25, 2016

First Posted

May 6, 2016

Study Start

May 1, 2016

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

December 5, 2016

Results First Posted

October 21, 2016

Record last verified: 2016-07

Locations

CN(1)