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

Sponsor
Mahidol University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05628246
Collaborator
(none)
206
1
2
29.9
6.9

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Telemedicine
  • Other: In-person
N/A

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

Study Type:
Interventional
Anticipated Enrollment :
206 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Health Services Research
Official Title:
Telemedicine Improves Pain-related Disabilities in Following up Cancer Pain Outpatient: A Prospective Non-randomized Study.
Actual Study Start Date :
Jan 19, 2023
Anticipated Primary Completion Date :
Jul 17, 2025
Anticipated Study Completion Date :
Jul 17, 2025

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: In-person

Face to face at OPD

Other: In-person
In-person

Experimental: Telemedicine

Telemedicine

Other: Telemedicine
Telemedicine

Outcome Measures

Primary Outcome Measures

  1. Pain interference [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.

Secondary Outcome Measures

  1. Quality of life (QoL) [at 1 month]

    The quality of life will be assessed and compared using EuroQoL 5D5L between In-person group and telemedicine group.

  2. Pain intensity [at 1 month, 2 months and 3 months]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Faculty of medicine Siriraj Hospital Mahidol University Bangkoknoi Bangkok Thailand 10700

Sponsors and Collaborators

  • Mahidol University

Investigators

  • Study Director: Suratsawadee Wangnamthip, M.D., Mahidol University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mahidol University
ClinicalTrials.gov Identifier:
NCT05628246
Other Study ID Numbers:
  • Si 310/2022
First Posted:
Nov 28, 2022
Last Update Posted:
Jan 27, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 27, 2023