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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05856292
Other study ID # TarumanagaraU
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 1, 2022
Est. completion date June 30, 2022

Study information

Verified date May 2023
Source Tarumanagara University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This randomized prospective quantitative pilot study compared teach-back method to standardized educational method in patient and caregiver to improve cancer pain management


Description:

Even though there are comprehensive guidelines for cancer pain management, pain control among cancer patients and survivors is often suboptimal due to undertreatment. According to recent studies, the addition of educational interventions could improve pain relief in cancer patients. Both patients and family caregivers play an important role in delivering cancer pain self-management, especially at home. Providing knowledge for cancer pain management with optimal intervention could improve patient and caregiver outcomes. The Teach-back method, where patients and family caregivers are asked to repeat the instruction they've received from their health care professionals, can assess patients' understanding, repeat or modify the educational material if comprehension is not demonstrated. This pilot study compared the addition of the Teach-back method for cancer patients and their caregivers and its relation to cancer pain management.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date June 30, 2022
Est. primary completion date June 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Moderate to severe pain (pain scale 4 and above) - =18 years old - Signed the informed consent - Willing to cooperate until the end of studies - The patient is fully conscious and able to communicate well - Cared by a family caregiver - Family caregiver able to fully function as a caregiver Exclusion Criteria: - Near-death (dying) stage - Not willing to cooperate until the end of studies - Altered mental status and communication difficulties

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Teach Back
Standard cancer pain educational intervention enhanced with teach-back method
Placebo
Standard cancer pain educational intervention without enhancement

Locations

Country Name City State
Indonesia Dharmais National Cancer Centre Jakarta

Sponsors (1)

Lead Sponsor Collaborator
Tarumanagara University

Country where clinical trial is conducted

Indonesia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Cancer pain management Quality of cancer pain management. Patient Global Impression Change (PGIC) scale is used to measure the overall quality of life and satisfaction as a conclusion toward the intervention one month
Secondary Health Literacy using Health Literacy Short Form Survey Questionnaire (HLS-EU-SQ10-IDN) to measure the change in health literacy one month
Secondary Pain Level using Brief Pain Inventory (BPI) to measure the change in pain level weekly up to one month
Secondary Distress using distress thermometer to measure change in distress weekly up to one month
Secondary Belief using Barriers Questionnaire (BQ-13) to measure change in belief one month
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