Trial Outcomes & Findings for Intelligent Pain Management System for Assessing Pain in Cancer Patients (NCT NCT02765269)
NCT ID: NCT02765269
Last Updated: 2016-12-05
Results Overview
The primary objective is to demonstrate that this mobile application is feasible by observing the numbers of daily pain assessment among patients.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
46 participants
Primary outcome timeframe
2 weeks
Results posted on
2016-12-05
Participant Flow
Participant milestones
| Measure |
IPMS Group
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.
Intelligent Pain Management System: 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.
|
Control Group
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.
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
21
|
|
Overall Study
COMPLETED
|
25
|
21
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Intelligent Pain Management System for Assessing Pain in Cancer Patients
Baseline characteristics by cohort
| Measure |
IPMS Group
n=25 Participants
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.
Intelligent Pain Management System: 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.
|
Control Group
n=21 Participants
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.
|
Total
n=46 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Gender
Female
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Gender
Male
|
19 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Region of Enrollment
China
|
25 participants
n=5 Participants
|
21 participants
n=7 Participants
|
46 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 weeksThe primary objective is to demonstrate that this mobile application is feasible by observing the numbers of daily pain assessment among patients.
Outcome measures
| Measure |
IPMS Group
n=25 Participants
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.
Intelligent Pain Management System: 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.
|
Control Group
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.
|
|---|---|---|
|
Feasibility of Mobile Application Assessed by Observing the Number of Daily Pain Assessments Recorded Among Patients
|
2.37 pain assessments per day
Standard Deviation 0.53
|
—
|
SECONDARY outcome
Timeframe: 2 weeksNumerical rating scale allows a person to describe the intensity of his/her pain as a number usually ranging from 0 to 10, where "0" means "no pain" and "10" means pain as "bad as it could be". Higher values means worse outcomes. The investigators will compare average pain score assessed by numerical rating scale at the end of the trial period.
Outcome measures
| Measure |
IPMS Group
n=25 Participants
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.
Intelligent Pain Management System: 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.
|
Control Group
n=21 Participants
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.
|
|---|---|---|
|
Pain Management
|
2.20 scores on a scale
Standard Deviation 0.50
|
2.95 scores on a scale
Standard Deviation 0.59
|
SECONDARY outcome
Timeframe: 2 weeksPatients will be asked to complete a questionnaire after patients use it for 2 weeks.
Outcome measures
| Measure |
IPMS Group
n=25 Participants
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.
Intelligent Pain Management System: 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.
|
Control Group
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.
|
|---|---|---|
|
Users' Satisfaction (Questionnaire)
very much like IPMS
|
9 participants
|
—
|
|
Users' Satisfaction (Questionnaire)
like IMPS
|
16 participants
|
—
|
|
Users' Satisfaction (Questionnaire)
dislike IPMS
|
0 participants
|
—
|
SECONDARY outcome
Timeframe: 2 weeksThe Karnofsky performance score runs from 100 to 0, where 100 is "perfect" health and 0 is death. Higher values represent better outcomes.The investigators will compare average score between trial group and control group.
Outcome measures
| Measure |
IPMS Group
n=25 Participants
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.
Intelligent Pain Management System: 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.
|
Control Group
n=21 Participants
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.
|
|---|---|---|
|
Karnofsky Performance Score Evaluation
|
68.80 scores on a scale
Standard Deviation 7.23
|
56.19 scores on a scale
Standard Deviation 7.40
|
Adverse Events
IPMS Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Gang Ding
Xinhua Translational Institute for Cancer Pain, Shanghai
Phone: 021-69691540
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place