Clinical trial NCT05628246: 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
Overall status: RECRUITING
Phase: NA
Conditions: Pain, Chronic
Cancer Pain
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2022-11-28
Enrollment: 206
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Pain interference
timeFrame: at 1 month
Secondary outcomes:
measure: Quality of life (QoL)
timeFrame: at 1 month
measure: Pain intensity
timeFrame: at 1 month, 2 months and 3 months
Other outcomes:
Locations:
city: Bangkoknoi
country: Thailand
facility: Faculty of medicine Siriraj Hospital Mahidol University
state: Bangkok
Study officials:
affiliation: Mahidol University
name: Suratsawadee Wangnamthip, M.D.
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.