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

NCT05856292 | Completed DMC

• 1 other identifier: TarumanagaraU
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Cancer Pain

Keywords

Cancer Pain; Education

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Health Literacy

  one month

• Pain Level

  weekly up to one month

• Distress

  weekly up to one month

• Belief

  one month

Study Arms (2)

Teach-Back

EXPERIMENTAL

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

Non-Teach-Back

PLACEBO COMPARATOR

No educational intervention, just standard educational methods

Other: Placebo

Interventions

Teach Back OTHER

Standard cancer pain educational intervention enhanced with teach-back method

Teach-Back

Placebo OTHER

Standard cancer pain educational intervention without enhancement

Non-Teach-Back

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Near-death (dying) stage
• Not willing to cooperate until the end of studies
• Altered mental status and communication difficulties

Sponsors & Collaborators

• Tarumanagara University: lead

Study Sites (1)

Dharmais National Cancer Centre

Jakarta, 11420, Indonesia

Location

MeSH Terms

Conditions

Cancer Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Group 1: Placebo Group 2: Teach-Back

Study Record Dates

• First Submitted: April 11, 2023
• First Posted: May 12, 2023
• Study Start: March 1, 2022
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: May 12, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)