Cancer PainNCT05856292
Improving Cancer Pain Management Through Teach-Back Educational Approach for Patients and Primary Caregivers: A Pilot Study
A study testing Teach Back in people with Cancer Pain, run by Tarumanagara University at 1 site in Indonesia.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer Pain
- What is being tested?
- Teach Back
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Mar 2022to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Near-death (dying) stage
- Not willing to cooperate until the end of studies
- Altered mental status and communication difficulties
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Cancer Pain
- Being tested
- Teach Back, Placebo
- Keywords
- Cancer Pain, Education
- Medical subject headings
- Cancer Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Teach BackOther
Standard cancer pain educational intervention enhanced with teach-back method
PlaceboOther
Standard cancer pain educational intervention without enhancement
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Teach Back |
| Non-Teach-Back | Placebo comparator | No educational intervention, just standard educational methods Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: one month
Secondary outcomes (4)
Health Literacy
using Health Literacy Short Form Survey Questionnaire (HLS-EU-SQ10-IDN) to measure the change in health literacy
Measured: one month
Pain Level
using Brief Pain Inventory (BPI) to measure the change in pain level
Measured: weekly up to one month
Distress
using distress thermometer to measure change in distress
Measured: weekly up to one month
Belief
using Barriers Questionnaire (BQ-13) to measure change in belief
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2023
- Study start1 Mar 2022
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group 1: Placebo Group 2: Teach-Back
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tarumanagara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ricky Dosan, Tarumanagara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05856292
- Sponsor's protocol ID
- TarumanagaraU
- Status last verified
- May 2023
- First submitted
- 11 Apr 2023
- Last updated
- 12 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Cancer Pain Management Through Teach-Back Educational Approach for Patients and Primary Caregivers: A Pilot Study
- ClinicalTrials.gov ID
- NCT05856292
- Acronym / sponsor ID
- TarumanagaraU
- Conditions
- Cancer Pain
- Keywords
- Cancer Pain, Education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Tarumanagara UniversityUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 12 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Group 1: Placebo Group 2: Teach-Back
| Arm | Type | Receives |
|---|---|---|
| Teach-Back | Experimental | Other: Teach BackThe 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 |
| Non-Teach-Back | Placebo comparator | Other: PlaceboNo educational intervention, just standard educational methods |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- Near-death (dying) stage
- Not willing to cooperate until the end of studies
- Altered mental status and communication difficulties
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Teach BackStandard cancer pain educational intervention enhanced with teach-back method | Other | Teach-Back |
| PlaceboStandard cancer pain educational intervention without enhancement | Other | Non-Teach-Back |
Primary outcome
Cancer pain management
Time frame: 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
4 secondary outcomes
Health Literacy
Time frame: one month
Pain Level
Time frame: weekly up to one month
Distress
Time frame: weekly up to one month
Belief
Time frame: one month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Teach Back in people with Cancer Pain, run by Tarumanagara University at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cancer pain management (time frame: one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2023.