Improving Cancer Pain Management Through Teach-Back Educational Approach for Patients and Primary Caregivers: A Pilot Study

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

Study Overview

• Status: Completed
• Conditions: Cancer Pain
• Intervention / Treatment: Other: Teach Back; Other: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Indonesia
  • Jakarta, Indonesia, 11420
    • Dharmais National Cancer Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Teach-Back; 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	Other: Teach Back; Standard cancer pain educational intervention enhanced with teach-back method
Placebo Comparator: Non-Teach-Back; No educational intervention, just standard educational methods	Other: Placebo; Standard cancer pain educational intervention without enhancement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health Literacy	using Health Literacy Short Form Survey Questionnaire (HLS-EU-SQ10-IDN) to measure the change in health literacy	one month
Pain Level	using Brief Pain Inventory (BPI) to measure the change in pain level	weekly up to one month
Distress	using distress thermometer to measure change in distress	weekly up to one month
Belief	using Barriers Questionnaire (BQ-13) to measure change in belief	one month

Collaborators and Investigators

• Sponsor: Tarumanagara University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Actual): June 30, 2022
• Study Completion (Actual): June 30, 2022

Study Registration Dates

• First Submitted: April 11, 2023
• First Submitted That Met QC Criteria: May 3, 2023
• First Posted (Actual): May 12, 2023

Study Record Updates

• Last Update Posted (Actual): May 12, 2023
• Last Update Submitted That Met QC Criteria: May 3, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Education; Cancer Pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Cancer Pain
• Other Study ID Numbers: TarumanagaraU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No