Clinical trial NCT03671382: Communication During Medical Consultations in Singapore -Pilot
Official title: Training Oncologists and Empowering Patients in Affective Communication During Medical Consultations in Singapore (TEAMS) - A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Communication Research
Keywords: Cancer
Lead sponsor: Duke-NUS Graduate Medical School
Sponsor class: OTHER
First posted: 2018-09-14
Enrollment: 104
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

The inclusion criteria for oncologists are

1. All consultants and senior residents/registrars in the Departments of Medical Oncology at National Cancer Centre, Singapore
2. Able to allow audio-recording during consultation

The inclusion criteria for patients are

1. Age ≥ 21 years old
2. Patients who are consulting an oncologist who is participating in the study
3. Patients who are Singaporeans or Singapore Permanent Residents
4. Diagnosis of stage IV cancer (with metastasis to visceral organs)
5. Able to allow audio-recording during consultation

Exclusion Criteria:

The exclusion criteria for oncologists are

a. Rejecting audio-recording during consultation

The exclusion criteria for patients are

1. Age ≤ 21 years old
2. Patients who are not Singaporeans or Singapore Permanent Residents
3. Rejecting audio-recording during consultation
4. Patients with psychiatric or cognitive disorder.

Primary outcomes:
measure: Assess feasibility and acceptability of intervention
timeFrame: up to 3 months
Secondary outcomes:
measure: Assess increase in number of empathic statements by oncologists
timeFrame: within 5 months
measure: Assess increase in number of questions related to their prognosis asked by patients
timeFrame: within 5 months
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National Cancer Centre Singapore
Study officials:
affiliation: Duke-NUS Graduate Medical School
name: Chetna Malhotra, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: