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Telemedicine Improves Pain-related Disabilities in Following up Cancer Pain Outpatient

Primary Purpose

Pain, Chronic, Cancer Pain

Status
Recruiting
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Telemedicine
In-person
Sponsored by
Mahidol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Pain, Chronic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age older than 18 years old Cancer patients who new visit as out patient at pain clinic, Siriraj hospital Exclusion Criteria: Cannot read and write Confusion Unable to use the 0-10 Numerical Rating Scale (NRS) to rate pain intensity. Unstable clinical presentation

Sites / Locations

  • Faculty of medicine Siriraj Hospital Mahidol UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

In-person

Telemedicine

Arm Description

Face to face at OPD

Telemedicine

Outcomes

Primary Outcome Measures

Pain interference
The pain interference will be assessed and compared using Brief Pain Inventory from 0-70 between In-person group and telemedicine group.

Secondary Outcome Measures

Quality of life (QoL)
The quality of life will be assessed and compared using EuroQoL 5D5L between In-person group and telemedicine group.
Pain intensity
The pain reduction will be assessed and compared using numerical rating (NRS) from 0-10; 0 designating "no pain" and 10 designating " worst possible pain" scale between In-person group and telemedicine group.

Full Information

First Posted
November 15, 2022
Last Updated
January 26, 2023
Sponsor
Mahidol University
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1. Study Identification

Unique Protocol Identification Number
NCT05628246
Brief Title
Telemedicine Improves Pain-related Disabilities in Following up Cancer Pain Outpatient
Official Title
Telemedicine Improves Pain-related Disabilities in Following up Cancer Pain Outpatient: A Prospective Non-randomized Study.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 19, 2023 (Actual)
Primary Completion Date
July 17, 2025 (Anticipated)
Study Completion Date
July 17, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mahidol University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Cancer is the second leading cause of death worldwide, with approximately 18.1 million new cases and 9.6 million deaths reported in 2018. Cancer-related pain is experienced by 50-70% of patients, with a higher prevalence at advanced disease stages (66.4%). Since the development of WHO's cancer pain guidelines, several studies have reported good relief of symptoms and suffering for a majority of patients. Recent reports suggest that up to 50% of patients still report insufficient pain control. Patients with cancer often present with multiple symptoms and functional decline. Evidence supports multidisciplinary approaches to address symptoms and suffering, including early palliative care referral From review literatures we found that the telemedicine group had significantly higher quality of life than the usual care group. In addition, the telemedicine group had lower anxiety and depression scores than the usual care group. Therefore, we will conduct the non-randomized controlled study of using telemedicine comparing to conventional in-person at OPD in hospitalized cancer pain patients. The purpose of this study is to assess the pain interference by using the Brief Pain Inventory (BPI) and to compare between the in-person group and the telemedicine group. To assess the cost-effectiveness of telemedicine for reducing symptoms associated with cancer and its treatment.
Detailed Description
The pain interference will be assessed and compared using Brief Pain Inventory from 0-70 between In-person group and telemedicine group at 1 month.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Chronic, Cancer Pain

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
206 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
In-person
Arm Type
Active Comparator
Arm Description
Face to face at OPD
Arm Title
Telemedicine
Arm Type
Experimental
Arm Description
Telemedicine
Intervention Type
Other
Intervention Name(s)
Telemedicine
Intervention Description
Telemedicine
Intervention Type
Other
Intervention Name(s)
In-person
Intervention Description
In-person
Primary Outcome Measure Information:
Title
Pain interference
Description
The pain interference will be assessed and compared using Brief Pain Inventory from 0-70 between In-person group and telemedicine group.
Time Frame
at 1 month
Secondary Outcome Measure Information:
Title
Quality of life (QoL)
Description
The quality of life will be assessed and compared using EuroQoL 5D5L between In-person group and telemedicine group.
Time Frame
at 1 month
Title
Pain intensity
Description
The pain reduction will be assessed and compared using numerical rating (NRS) from 0-10; 0 designating "no pain" and 10 designating " worst possible pain" scale between In-person group and telemedicine group.
Time Frame
at 1 month, 2 months and 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age older than 18 years old Cancer patients who new visit as out patient at pain clinic, Siriraj hospital Exclusion Criteria: Cannot read and write Confusion Unable to use the 0-10 Numerical Rating Scale (NRS) to rate pain intensity. Unstable clinical presentation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Suratsawadee Wangnamthip, M.D.
Phone
+66-81-926-1509
Email
suratsawadee.wan@mahidol.ac.th
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suratsawadee Wangnamthip, M.D.
Organizational Affiliation
Mahidol University
Official's Role
Study Director
Facility Information:
Facility Name
Faculty of medicine Siriraj Hospital Mahidol University
City
Bangkoknoi
State/Province
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suratsawadee Wangnamthip, M.D.
Phone
+66-81-926-1509
Email
suratsawadee.wan@mahidol.ac.th
First Name & Middle Initial & Last Name & Degree
Suratsawadee Wangnamthip, M.D.

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33101621
Citation
Pang L, Liu Z, Lin S, Liu Z, Liu H, Mai Z, Liu Z, Chen C, Zhao Q. The effects of telemedicine on the quality of life of patients with lung cancer: a systematic review and meta-analysis. Ther Adv Chronic Dis. 2020 Oct 7;11:2040622320961597. doi: 10.1177/2040622320961597. eCollection 2020.
Results Reference
result
PubMed Identifier
34336068
Citation
Wangnamthip S, Panchoowong S, Donado C, Lobo K, Phankhongsap P, Sriveerachai P, Euasobhon P, Rushatamukayanunt P, Mandee S, Zinboonyahgoon N, Berde CB. The Effectiveness of Cancer Pain Management in a Tertiary Hospital Outpatient Pain Clinic in Thailand: A Prospective Observational Study. Pain Res Manag. 2021 Jul 20;2021:5599023. doi: 10.1155/2021/5599023. eCollection 2021.
Results Reference
result
PubMed Identifier
19260241
Citation
Chaudakshetrin P. Validation of the Thai Version of Brief Pain Inventory (BPI-T) in cancer patients. J Med Assoc Thai. 2009 Jan;92(1):34-40.
Results Reference
result
PubMed Identifier
29958008
Citation
Pattanaphesaj J, Thavorncharoensap M, Ramos-Goni JM, Tongsiri S, Ingsrisawang L, Teerawattananon Y. The EQ-5D-5L Valuation study in Thailand. Expert Rev Pharmacoecon Outcomes Res. 2018 Oct;18(5):551-558. doi: 10.1080/14737167.2018.1494574. Epub 2018 Jul 6.
Results Reference
result

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Telemedicine Improves Pain-related Disabilities in Following up Cancer Pain Outpatient

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