NCT06791213

Brief Summary

According to the International Association for the Study of Pain (IASP), pain is an unpleasant sensory and emotional experience associated with, or resembling that associated with, actual or potential tissue damage . Despite advances in precision medicine, pain remains a common complaint among cancer patients, with 44.5% reporting pain and a 30.6% prevalence of moderate to severe pain. In Taiwan, over half of cancer patients experience pain in the week leading up to their outpatient visit, with 54% of oncology outpatients reporting pain issues. Of these, only 58% receive analgesics, with more medications given to those with worsening conditions. Pain significantly affects sleep, and over 50% of patients feel pain despite analgesic control. Research indicates that Asian patients often view cancer negatively, avoiding discussions about their condition, which normalizes their pain and potentially worsens it. Enhancing patient self-efficacy can increase satisfaction with pain management, and it is recommended that healthcare professionals develop interventions to improve pain management satisfaction. Self-management interventions have shown effectiveness in improving pain-related knowledge and quality of life. These interventions can encompass patient attitudes and knowledge, with guidance and consultation from nurses reinforcing information about pain management and medication adherence. In clinical settings, nurses may be too busy to provide comprehensive and consistent health education, leading to insufficient patient understanding of medications. Digital multimedia health education tools, which use visual aids, can better capture patients' attention and facilitate unrestricted learning regardless of time or place, leading to improved learning outcomes. This study aims to investigate the effectiveness of "digital multimedia" in reducing pain, enhancing medication adherence, and improving pain control satisfaction among patients. The goal is to overcome the limitations of busy healthcare providers, allowing patients to learn independently, understand pain and analgesic use, dispel myths about pain medications, and enhance pain control, ultimately improving self-care capabilities, pain control satisfaction, and quality of life.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
98

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 13, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 24, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2025

Completed
Last Updated

March 19, 2025

Status Verified

October 1, 2024

Enrollment Period

6 months

First QC Date

January 13, 2025

Last Update Submit

March 18, 2025

Conditions

Keywords

Cancer PainDigital Multimedia Health EducationAnalgesic AdherencePain Control Satisfaction

Outcome Measures

Primary Outcomes (3)

  • Cancer pain

    This study defines its operational terms using the Taiwanese version of the Brief Pain Inventory (BPI-T). Pain is assessed through the Numerical Rating Scale (NRS), which evaluates pain severity on a scale ranging from 0 to 10. Higher scores indic.

    From enrollment to the end of treatment at 12 weeks

  • Analgesic Adherence

    1. Calculate the total amount of pain medication consumed by patients and the total amount prescribed by physicians to determine the medication adherence percentage. Additionally, convert opioid prescriptions into morphine-equivalent doses to calculate the medication adherence percentage. 2. The 4-item Morisky Medication Adherence Scale (MMAS-4) was used for assessment. This structured measurement scale was originally developed by Morisky et al. (1986) and consists of four questions. The MMAS-4 scores indicate medication adherence, with higher scores representing greater adherence to prescribed medication.

    From enrollment to the end of treatment at 12 weeks

  • Pain Control Satisfaction

    The Pain Treatment Satisfaction Scale (PTSS) was adopted for psychometric assessment and validation in patients with acute and chronic pain. The scale evaluates various aspects, including pain severity, information about pain and its treatment, medication therapy, the effects of current pain medications, the route of administration, medication side effects, and satisfaction with current pain medications and overall care.

    From enrollment to the end of treatment at 12 weeks

Study Arms (2)

Treatment group

EXPERIMENTAL

Digital Multimedia Health Education

Other: Digital Multimedia Health Education

Control group

NO INTERVENTION

Interventions

This study aims to investigate the effectiveness of "digital multimedia" in reducing pain, enhancing medication adherence, and improving pain control satisfaction among patients. The goal is to overcome the limitations of busy healthcare providers, allowing patients to learn independently, understand pain and analgesic use, dispel myths about pain medications, and enhance pain control, ultimately improving self-care capabilities, pain control satisfaction, and quality of life.

Treatment group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults aged over 18 years.
  • Diagnosed with a solid tumor and reporting a pain score of 4 or higher.
  • Patients using prescribed strong opioid medications for pain management.
  • Conscious, capable of communicating in Mandarin, understanding Mandarin, or -Able to write in text.
  • Able to operate electronic devices (e.g., smartphones, tablets, or computers) independently, or with assistance from family members or caregivers.

You may not qualify if:

  • Patients with visual or auditory impairments.
  • Patients with cognitive impairments.
  • Diagnosed by a physician as having substance addiction (addictive substances include central nervous system depressants: opioids, heroin, ketamine; central nervous system stimulants: amphetamines, ecstasy, cocaine; and central nervous system hallucinogens: cannabis).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

13F., No. 119, Ln. 136, Sec. 3, Zhongshan Rd., Zhonghe Dist., New Taipei City 235 , Taiwan (R.O.C.)

New Taipei City, 235, Taiwan

Location

MeSH Terms

Conditions

Cancer Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2025

First Posted

January 24, 2025

Study Start

April 1, 2025

Primary Completion

October 1, 2025

Study Completion

November 1, 2025

Last Updated

March 19, 2025

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations