Communication ResearchTEAMS-pilotNCT03671382
Communication During Medical Consultations in Singapore -Pilot
A study testing Communication Training Program and Patient Prompt Sheet in people with Communication Research, run by Duke-NUS Graduate Medical School at 1 site in Singapore.
Trial summary
Despite advanced cancer patients and their caregivers frequently experiencing psychological distress and wanting to know about their prognosis, oncologists rarely respond with empathy and provide adequate information regarding patient prognosis. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Communication Research
- What is being tested?
- Communication Training Program and Patient Prompt Sheet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteSingapore
- Study dates
- 31 Jul 2018to 1 Feb 2019
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The inclusion criteria for oncologists are
- All consultants and senior residents/registrars in the Departments of Medical Oncology at National Cancer Centre, Singapore
- Able to allow audio-recording during consultation
- The inclusion criteria for patients are
- Age ≥ 21 years old
- Patients who are consulting an oncologist who is participating in the study
Show all 9Show fewer
- Patients who are Singaporeans or Singapore Permanent Residents
- Diagnosis of stage IV cancer (with metastasis to visceral organs)
- Able to allow audio-recording during consultation
Who cannot join
- The exclusion criteria for oncologists are
- Rejecting audio-recording during consultation
- The exclusion criteria for patients are
- Age ≤ 21 years old
- Patients who are not Singaporeans or Singapore Permanent Residents
- Rejecting audio-recording during consultation
- Patients with psychiatric or cognitive disorder.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Training Oncologists and Empowering Patients in Affective Communication During Medical Consultations in Singapore (TEAMS) - A Pilot Study
Despite advanced cancer patients and their caregivers frequently experiencing psychological distress and wanting to know about their prognosis, oncologists rarely respond with empathy and provide adequate information regarding patient prognosis. We aim to address the communication gap during consultations by developing an Oncologist E-Learning Communications Skills Training Program guiding physicians on how to recognize and respond to patient/caregiver distress and to disclose prognosis; and a Patient Prompt Sheet to encourage discussions of psychological distress and prognosis. We will assess the feasibility of delivering this two-component intervention program within a cancer center in Singapore through a 2-arm randomized controlled trial in which 8 oncologists will be randomly assigned to Control Arm (n=4) and Intervention Arm (n=4). Oncologists in the intervention arm will receive the E-Learning Program. Their patients will also receive the Patient Prompt Sheet before their consultation with oncologist. After completion of oncologist intervention we will audio-record and survey 3 patients with Stage IV cancer and their caregivers per oncologist before and after their consultations. If the study is shown to be feasible and acceptable, then its effectiveness will be assessed in a larger trial.
- Conditions
- Communication Research
- Being tested
- Communication Training Program and Patient Prompt Sheet
- Keywords
- Cancer
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Communication Training Program and Patient Prompt SheetBehavioural
The intervention being delivered is a two-component intervent. First component is the Oncologist Communication Skills Training Program. This is an e-learning module teaching oncologists to recognize and respond to patient/caregiver distress, provide information including prognosis and discuss goals of care. The second component is a patient prompt sheet which will be administered to three patients of intervention arm oncologists in the waiting area at least 30 minutes before their consultation. The sheet includes structured questions for patients to ask the oncologist about diagnosis and prognosis and will prompt patients to label and express their emotions in a direct manner.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | Communication Training Program and Patient Prompt Sheet Receives: Behavioral: Communication Training Program and Patient Prompt Sheet |
| Control Arm | No intervention | Oncologists will not receive the communication skills training program and their patients will not receive the Patient Prompt Sheet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess feasibility and acceptability of intervention
Measured by proportion of intervention arm oncologists completing their intervention
Measured: up to 3 months
Secondary outcomes (2)
Assess increase in number of empathic statements by oncologists
Measured by coding audio-recorded consultations post-intervention
Measured: within 5 months
Assess increase in number of questions related to their prognosis asked by patients
Measured by coding audio-recorded consultations post-intervention
Measured: within 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2018
- Study start31 Jul 2018
- Primary completion1 Feb 2019
- Study completion1 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Communication ResearchStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke-NUS Graduate Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chetna Malhotra, Duke-NUS Graduate Medical School
- Investigators
- Chetna Malhotra, MD, MPH, Principal investigator, Duke-NUS Graduate Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03671382
- Sponsor's protocol ID
- LCPC-IN
- Acronym
- TEAMS-pilot
- Status last verified
- Feb 2019
- First submitted
- 2 Sep 2018
- Last updated
- 8 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- 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 8 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Training Oncologists and Empowering Patients in Affective Communication During Medical Consultations in Singapore (TEAMS) - A Pilot Study
- ClinicalTrials.gov ID
- NCT03671382
- Acronym / sponsor ID
- TEAMS-pilot / LCPC-IN
- Conditions
- Communication Research
- Keywords
- Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Duke-NUS Graduate Medical SchoolUniversity, hospital or other
- Study start
- 31 Jul 2018 (actual)
- Primary completion
- 1 Feb 2019 (actual)
- Study completion
- 1 Feb 2019 (actual)
- First posted
- 14 Sep 2018 (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.
Despite advanced cancer patients and their caregivers frequently experiencing psychological distress and wanting to know about their prognosis, oncologists rarely respond with empathy and provide adequate information regarding patient prognosis. We aim to address the communication gap during consultations by developing an Oncologist E-Learning Communications Skills Training Program guiding physicians on how to recognize and respond to patient/caregiver distress and to disclose prognosis; and a Patient Prompt Sheet to encourage discussions of psychological distress and prognosis. We will assess the feasibility of delivering this two-component intervention program within a cancer center in Singapore through a 2-arm randomized controlled trial in which 8 oncologists will be randomly assigned to Control Arm (n=4) and Intervention Arm (n=4). Oncologists in the intervention arm will receive the E-Learning Program. Their patients will also receive the Patient Prompt Sheet before their consultation with oncologist. After completion of oncologist intervention we will audio-record and survey 3 patients with Stage IV cancer and their caregivers per oncologist before and after their consultations. If the study is shown to be feasible and acceptable, then its effectiveness will be assessed in a larger trial.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Behavioral: Communication Training Program and Patient Prompt SheetCommunication Training Program and Patient Prompt Sheet |
| Control Arm | No intervention | –Oncologists will not receive the communication skills training program and their patients will not receive the Patient Prompt Sheet |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- The inclusion criteria for oncologists are
- All consultants and senior residents/registrars in the Departments of Medical Oncology at National Cancer Centre, Singapore
- Able to allow audio-recording during consultation
- The inclusion criteria for patients are
- Age ≥ 21 years old
Key exclusion criteria (7 listed)
- The exclusion criteria for oncologists are
- Rejecting audio-recording during consultation
- The exclusion criteria for patients are
- Age ≤ 21 years old
- Patients who are not Singaporeans or Singapore Permanent Residents
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 |
|---|---|---|
| Communication Training Program and Patient Prompt SheetThe intervention being delivered is a two-component intervent. First component is the Oncologist Communication Skills Training Program. This is an e-learning module teaching oncologists to recognize and respond to patient/caregiver distress, provide information including prognosis and discuss goals of care. The second component is a patient prompt sheet which will be administered to three patients of intervention arm oncologists in the waiting area at least 30 minutes before their consultation. The sheet includes structured questions for patients to ask the oncologist about diagnosis and prognosis and will prompt patients to label and express their emotions in a direct manner. | Behavioural | Intervention Arm |
Primary outcome
Assess feasibility and acceptability of intervention
Time frame: up to 3 months
Measured by proportion of intervention arm oncologists completing their intervention
2 secondary outcomes
Assess increase in number of empathic statements by oncologists
Time frame: within 5 months
Assess increase in number of questions related to their prognosis asked by patients
Time frame: within 5 months
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 8 Feb 2019.
- 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.
Chetna Malhotra, MD, MPH principal investigator
Duke-NUS Graduate Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Communication Training Program and Patient Prompt Sheet in people with Communication Research, run by Duke-NUS Graduate Medical School at 1 site in Singapore.
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 9 inclusion and 7 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 8 Feb 2019. 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 Singapore. 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. 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?
Assess feasibility and acceptability of intervention (time frame: up to 3 months). 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 8 Feb 2019.