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

• Sponsor: Tarumanagara University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05856292
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Actual Duration (Months): 4
• Patients Per Site Per Month: 10.1

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Cancer Pain	Other: Teach Back; Other: Placebo	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Group 1: Placebo Group 2: Teach-BackGroup 1: Placebo Group 2: Teach-Back
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Improving Cancer Pain Management Through Teach-Back Educational Approach for Patients and Primary Caregivers: A Pilot Study
• Actual Study Start Date: Mar 1, 2022
• Actual Primary Completion Date: Jun 30, 2022
• Actual Study Completion Date: Jun 30, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Cancer pain management [one month]

   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

1. Health Literacy [one month]

   using Health Literacy Short Form Survey Questionnaire (HLS-EU-SQ10-IDN) to measure the change in health literacy

2. Pain Level [weekly up to one month]

   using Brief Pain Inventory (BPI) to measure the change in pain level

3. Distress [weekly up to one month]

   using distress thermometer to measure change in distress

4. Belief [one month]

   using Barriers Questionnaire (BQ-13) to measure change in belief

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dharmais National Cancer Centre	Jakarta		Indonesia	11420

Sponsors and Collaborators

• Tarumanagara University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ricky Dosan, Principal Investigator, Tarumanagara University
• ClinicalTrials.gov Identifier: NCT05856292
• Other Study ID Numbers: TarumanagaraU
• First Posted: May 12, 2023
• Last Update Posted: May 12, 2023
• Last Verified: May 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Ricky Dosan, Principal Investigator, Tarumanagara University: Cancer Pain; Education
• Additional relevant MeSH terms: Cancer Pain

Study Results

No Results Posted as of May 12, 2023