- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05628246
Telemedicine Improves Pain-related Disabilities in Following up Cancer Pain Outpatient
Telemedicine Improves Pain-related Disabilities in Following up Cancer Pain Outpatient: A Prospective Non-randomized Study.
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Bangkok
-
Bangkoknoi, Bangkok, Thailand, 10700
- Faculty of medicine Siriraj Hospital Mahidol University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: In-person
Face to face at OPD
|
In-person
|
|
Experimental: Telemedicine
|
Telemedicine
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain interference
Time Frame: at 1 month
|
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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quality of life (QoL)
Time Frame: at 1 month
|
The quality of life will be assessed and compared using EuroQoL 5D5L between In-person group and telemedicine group.
|
at 1 month
|
|
Pain intensity
Time Frame: at 1 month, 2 months and 3 months
|
The pain intensity from BPI (Brief Pain Inventory), including worst, least, average, and current pain reduction, will be assessed and compared using the numerical rating (NRS) from 0-10; 0 designating "no pain" and 10 designating " worst possible pain" scale between the in-person group and the telemedicine group.
|
at 1 month, 2 months and 3 months
|
|
Economic study
Time Frame: At Baseline, 1 month, 2 month and 3 month
|
We conducted an economic study evaluation from the patient and caregiver perspective.
Costs analyzed included direct medical costs, direct non-medical costs (such as transportation and food), and indirect costs (total productivity loss).
We calculated the Incremental Cost-Effectiveness Ratio (ICER) to determine the economic value of telemedicine relative to in-person care.
The ICER was defined as the incremental difference in total direct costs divided by the incremental difference in clinical effectiveness across multiple outcomes, including EQ-5D-5L utility, EQ-VAS, PPS, total BPI reduction, and avoided increases in MEDD.
The results were further visualized on a cost-effectiveness plane.
|
At Baseline, 1 month, 2 month and 3 month
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Suratsawadee Wangnamthip, M.D., Mahidol University
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Si 310/2022
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pain, Chronic
-
University Rovira i VirgiliMinisterio de Ciencia e Innovación, SpainNot yet recruitingChronic Post-operative Pain | Chronic Postsurgical Pain | Chronic Post-surgical Pain | Chronic Postoperative PainSpain
-
Pain ConcernThe Thistle Foundation; Health and Social Care Alliance Scotland (the ALLIANCE) and other collaboratorsCompletedChronic Pain | Chronic Pain Syndrome | Chronic Pain, Widespread | Chronic Pain Due to Trauma | Chronic Pain Due to Malignancy (Finding) | Chronic Pain Due to Injury | Chronic Pain Post-Procedural | Chronic Pain HipUnited Kingdom
-
Bjorn AngKarolinska Institutet; The Swedish Research Council; Göteborg University; Forte; Dalarna...Not yet recruitingPain Management | Pain, Chronic | Chronic Pain, WidespreadSweden
-
University of FaisalabadNot yet recruiting
-
Universidade do Vale do ParaíbaCAPES Foundation - Ministry of Education, Brazil.Enrolling by invitationChronic Low Back Pain | Chronic Shoulder Pain | Chronic Knee PainBrazil
-
Vastra Gotaland RegionCompletedPain, Chronic | Widespread Chronic PainSweden
-
Washington D.C. Veterans Affairs Medical CenterRecruitingChronic Back Pain | Chronic Pain (back / Neck)United States
-
Connecticut Children's Medical CenterRecruitingChronic Pain | Pain, Chronic | Chronic Pain SyndromeUnited States
-
The University of Texas Health Science Center,...RecruitingJoint Pain | Chronic Knee Pain | Chronic Pain (Back / Neck) | Chronic Pain ManagementUnited States
-
Pamukkale UniversityCompletedElderly | Pain, Chronic | Chronic Knee PainTurkey
Clinical Trials on In-person
-
Mayo ClinicCompletedTelemedicine | Primary Health Care | Diagnosis | Therapeutics | Developing CountriesHonduras
-
University of VermontNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); University...Completed
-
University of California, DavisCompletedPediatrics | Physical Therapy Modalities | Physical and Rehabilitation MedicineUnited States
-
Norges idrettshøgskoleKristiania University College; ABEL TechnologiesRecruiting
-
Yale UniversityNational Institute of Mental Health (NIMH)Recruiting
-
VA Office of Research and DevelopmentUniversity of Pennsylvania; University of HawaiiCompleted
-
Peking University Third HospitalPeking University First Hospital; Peking Union Medical College HospitalCompletedAnterior Cruciate Ligament ReconstructionChina
-
Dr. Nazanin AlaviOnline PsychoTherapy ClinicCompletedDepressive Disorder | Anxiety Disorders | Post-Traumatic Stress Disorder | Mental Health IssueCanada
-
Palo Alto Veterans Institute for ResearchNational Center for Complementary and Integrative Health (NCCIH)CompletedMusculoskeletal Pain | Chronic PainUnited States
-
VASCage GmbHMed-El Corporation; Tirol Kiniken GmbH; Oroboros Instruments; Österreichische GesundheitskasseRecruiting