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CompletedNCT05856292Updated May 12, 2023

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

An interventional study of Teach Back and Placebo in Cancer Pain, sponsored by Tarumanagara University. Completed at 1 site in Indonesia. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-05-12.

Sponsored by Tarumanagara University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 1 year 1 month after the study started (first participant enrolled Mar 2022, registered Apr 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Cancer Pain

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Keywords

  • Cancer Pain
  • Education
03

In context

Cancer Pain

310 studies on the registry are indexed under Cancer Pain; 73 are open to participants now.

This study's enrollment of 40 is below the median of 62 across 235 interventional studies indexed under Cancer Pain.

Browse Cancer Pain studies →

Lead sponsor

Tarumanagara University is the lead sponsor of 11 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Moderate to severe pain (pain scale 4 and above)
  • ≥18 years old
  • Signed the
  • 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

Exclusion Criteria:

  • Near-death (dying) stage
  • Not willing to cooperate until the end of studies
  • Altered mental status and communication difficulties
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • 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

  • Placebo comparator
    Non-Teach-Back

    No educational intervention, just standard educational methods

    Other: Placebo

Interventions

  • OtherTeach Back

    Standard cancer pain educational intervention enhanced with teach-back method

  • OtherPlacebo

    Standard cancer pain educational intervention without enhancement

06

What researchers measure

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

    Time frame: one month

Secondary outcomes

  1. Health Literacy

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

    Time frame: one month

  2. Pain Level

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

    Time frame: weekly up to one month

  3. Distress

    using distress thermometer to measure change in distress

    Time frame: weekly up to one month

  4. Belief

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

    Time frame: one month

07

Study locations

1 site
  • Dharmais National Cancer Centre
    Jakarta, 11420, Indonesia
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 12, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05856292
Lead sponsor
Tarumanagara University
Responsible party
Ricky Dosan (Principal Investigator, Tarumanagara University) — Principal investigator
First posted
May 12, 2023
Start date
Mar 1, 2022
Primary completion
Jun 30, 2022
Completion
Jun 30, 2022
Last update
May 12, 2023

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.

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