Pain, ChronicNCT05628246
Telemedicine Versus In-Person Follow-up for Cancer Pain Management: An Equity and Cost Analysis Comparison Using a Prospective Quasi-Experimental Design
A study testing Telemedicine and In-person in people with Pain, Chronic and Cancer Pain, run by Mahidol University at 1 site in Thailand.
Trial 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%). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Chronic, Cancer Pain, Cancer Related Pain
- What is being tested?
- Telemedicine and In-person
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 193 participants
- Where
- 1 siteThailand
- Study dates
- 19 Jan 2023to 31 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age older than 18 years old
- Cancer patients who new visit as out patient at pain clinic, Siriraj hospital
Who cannot join
- Cannot read and write
- Confusion
- Unable to use the 0-10 Numerical Rating Scale (NRS) to rate pain intensity.
- Unstable clinical presentation
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Faculty of medicine Siriraj Hospital Mahidol University
Bangkoknoi, Bangkok, 10700
About this 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.
Read more
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.
Read the 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.
- Conditions
- Pain, Chronic, Cancer Pain, Cancer Related Pain
- Being tested
- Telemedicine, In-person
- Keywords
- telemedicine, cancer pain, Pain management, Health equity, Cost-effectiveness analysis, Therapeutic equivalence, Palliative care
- Medical subject headings
- Chronic Pain, Cancer Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelemedicineOther
Telemedicine
In-personOther
In-person
| Study group | Role | What they receive |
|---|---|---|
| In-person | Active comparator | Face to face at OPD Receives: Other: In-person |
| Telemedicine | Experimental | Telemedicine Receives: Other: Telemedicine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain interference
The pain interference will be assessed and compared using Brief Pain Inventory from 0-70 between In-person group and telemedicine group.
Measured: at 1 month
Secondary outcomes (6)
Pain intensity
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.
Measured: at 1 month, 2 months and 3 months
Quality of life (QoL)
The quality of life will be assessed and compared using EuroQoL 5D5L between In-person group and telemedicine group.
Measured: at 1 month
Functional status
Functional status evaluated using Palliative Performance Status Score
Measured: At baseline, 1 month, 2 month, 3 month
Opioid consumption
Opioid consumption is recorded using the Morphine Equivalent Daily Dosage
Measured: At baseline, 1 month, 2 month and 3 month
Economic study
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.
Measured: At Baseline, 1 month, 2 month and 3 month
Medication adverse effects
Medication adverse effects such as sedation, constipation and nausea and vomiting were evaluated using the sedation score, Rome IV, and 4 point scale of nausea and vomiting.
Measured: At baseline, 1-month, 2-month and 3-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2022
- Study start19 Jan 2023
- Primary completion31 Jan 2026
- Study completion31 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pain, ChronicStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 193 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Suratsawadee Wangnamthip, M.D., Study director, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05628246
- Sponsor's protocol ID
- Si 310/2022
- Other IDs
- RO16535048
- Status last verified
- May 2026
- First submitted
- 15 Nov 2022
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 33101621Wangnamthip 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.
PubMed 34336068Chaudakshetrin 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.
PubMed 19260241Pattanaphesaj 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.
PubMed 29958008
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telemedicine Versus In-Person Follow-up for Cancer Pain Management: An Equity and Cost Analysis Comparison Using a Prospective Quasi-Experimental Design
- ClinicalTrials.gov ID
- NCT05628246
- Acronym / sponsor ID
- Si 310/2022
- Conditions
- Pain, Chronic, Cancer Pain, Cancer Related Pain
- Keywords
- telemedicine, cancer pain, Pain management, Health equity, Cost-effectiveness analysis, Therapeutic equivalence, Palliative care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 193 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 19 Jan 2023 (actual)
- Primary completion
- 31 Jan 2026 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 28 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| In-person | Active comparator | Other: In-personFace to face at OPD |
| Telemedicine | Experimental | Other: TelemedicineTelemedicine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age older than 18 years old
- Cancer patients who new visit as out patient at pain clinic, Siriraj hospital
Key exclusion criteria (4 listed)
- Cannot read and write
- Confusion
- Unable to use the 0-10 Numerical Rating Scale (NRS) to rate pain intensity.
- Unstable clinical presentation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TelemedicineTelemedicine | Other | Telemedicine |
| In-personIn-person | Other | In-person |
Primary outcome
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.
6 secondary outcomes
Pain intensity
Time frame: at 1 month, 2 months and 3 months
Quality of life (QoL)
Time frame: at 1 month
Functional status
Time frame: At baseline, 1 month, 2 month, 3 month
Opioid consumption
Time frame: At baseline, 1 month, 2 month and 3 month
Economic study
Time frame: At Baseline, 1 month, 2 month and 3 month
Medication adverse effects
Time frame: At baseline, 1-month, 2-month and 3-month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- Results publication: PubMed 33101621Pang 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 publication: PubMed 34336068Wangnamthip 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 publication: PubMed 19260241Chaudakshetrin 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 publication: PubMed 29958008Pattanaphesaj 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suratsawadee Wangnamthip, M.D. study director
Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telemedicine and In-person in people with Pain, Chronic and Cancer Pain, run by Mahidol University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain interference (time frame: at 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05628246, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.