Back to resultsImproving Cancer Pain Management Through Teach-Back Educational Approach for Patients and Primary Caregivers: A Pilot Study
Primary Purpose
Cancer Pain
Status
Completed
Phase
Not Applicable
Locations
Indonesia
Study Type
Interventional
Intervention
Teach Back
Placebo
Sponsored by
About this trial
This is an interventional supportive care trial for Cancer Pain focused on measuring Cancer Pain, Education
Eligibility Criteria
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
Sites / Locations
- Dharmais National Cancer Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Teach-Back
Non-Teach-Back
Arm Description
The intervention group were educated using the standard educational method with the addition of Teach-back enhancement. It consists of 5 steps: Triage, Tools, Take Responsibility, Tell Me, and Try Again. The Triage, Tools, and Try Again focus on effective information delivery, while the Take Responsibility and Tell Me evaluate the patient's ability to receive the information
No educational intervention, just standard educational methods
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Health Literacy
using Health Literacy Short Form Survey Questionnaire (HLS-EU-SQ10-IDN) to measure the change in health literacy
Pain Level
using Brief Pain Inventory (BPI) to measure the change in pain level
Distress
using distress thermometer to measure change in distress
Belief
using Barriers Questionnaire (BQ-13) to measure change in belief
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05856292
Brief Title
Improving Cancer Pain Management Through Teach-Back Educational Approach for Patients and Primary Caregivers: A Pilot Study
Official Title
Improving Cancer Pain Management Through Teach-Back Educational Approach for Patients and Primary Caregivers: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
June 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tarumanagara University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This randomized prospective quantitative pilot study compared teach-back method to standardized educational method in patient and caregiver to improve cancer pain management
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer Pain
Keywords
Cancer Pain, Education
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Group 1: Placebo Group 2: Teach-Back
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Teach-Back
Arm Type
Experimental
Arm Description
The intervention group were educated using the standard educational method with the addition of Teach-back enhancement. It consists of 5 steps: Triage, Tools, Take Responsibility, Tell Me, and Try Again. The Triage, Tools, and Try Again focus on effective information delivery, while the Take Responsibility and Tell Me evaluate the patient's ability to receive the information
Arm Title
Non-Teach-Back
Arm Type
Placebo Comparator
Arm Description
No educational intervention, just standard educational methods
Intervention Type
Other
Intervention Name(s)
Teach Back
Intervention Description
Standard cancer pain educational intervention enhanced with teach-back method
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Standard cancer pain educational intervention without enhancement
Primary Outcome Measure Information:
Title
Cancer pain management
Description
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
Time Frame
one month
Secondary Outcome Measure Information:
Title
Health Literacy
Description
using Health Literacy Short Form Survey Questionnaire (HLS-EU-SQ10-IDN) to measure the change in health literacy
Time Frame
one month
Title
Pain Level
Description
using Brief Pain Inventory (BPI) to measure the change in pain level
Time Frame
weekly up to one month
Title
Distress
Description
using distress thermometer to measure change in distress
Time Frame
weekly up to one month
Title
Belief
Description
using Barriers Questionnaire (BQ-13) to measure change in belief
Time Frame
one month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Dharmais National Cancer Centre
City
Jakarta
ZIP/Postal Code
11420
Country
Indonesia
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Improving Cancer Pain Management Through Teach-Back Educational Approach for Patients and Primary Caregivers: A Pilot Study
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