Communication During Medical Consultations in Singapore -Pilot (TEAMS-pilot)

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.

Study Overview

• Status: Completed
• Conditions: Communication Research
• Intervention / Treatment: Behavioral: Communication Training Program and Patient Prompt Sheet

• Study Type: Interventional
• Enrollment (Actual): 104
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 169610
    • National Cancer Centre Singapore

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Arm; Communication Training Program and Patient Prompt Sheet	Behavioral: Communication Training Program and Patient Prompt Sheet; 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.
No Intervention: Control Arm; Oncologists will not receive the communication skills training program and their patients will not receive the Patient Prompt Sheet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess feasibility and acceptability of intervention	Measured by proportion of intervention arm oncologists completing their intervention	up to 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess increase in number of empathic statements by oncologists	Measured by coding audio-recorded consultations post-intervention	within 5 months
Assess increase in number of questions related to their prognosis asked by patients	Measured by coding audio-recorded consultations post-intervention	within 5 months

Collaborators and Investigators

• Sponsor: Duke-NUS Graduate Medical School
• Investigators: Principal Investigator: Chetna Malhotra, MD, MPH, Duke-NUS Graduate Medical School

Study record dates

Study Major Dates

• Study Start (Actual): July 31, 2018
• Primary Completion (Actual): February 1, 2019
• Study Completion (Actual): February 1, 2019

Study Registration Dates

• First Submitted: September 2, 2018
• First Submitted That Met QC Criteria: September 13, 2018
• First Posted (Actual): September 14, 2018

Study Record Updates

• Last Update Posted (Actual): February 8, 2019
• Last Update Submitted That Met QC Criteria: February 6, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Cancer
• Other Study ID Numbers: LCPC-IN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No