TEAMS-pilot: Communication During Medical Consultations in Singapore -Pilot

• Sponsor: Duke-NUS Graduate Medical School (Other)
• Overall Status: Completed
• CT.gov ID: NCT03671382
• Collaborator: (none)
• Enrollment: 104
• Location: 1
• Arms: 2
• Actual Duration (Months): 6.1
• Patients Per Site Per Month: 17.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Communication Research	Behavioral: Communication Training Program and Patient Prompt Sheet	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 104 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Training Oncologists and Empowering Patients in Affective Communication During Medical Consultations in Singapore (TEAMS) - A Pilot Study
• Actual Study Start Date: Jul 31, 2018
• Actual Primary Completion Date: Feb 1, 2019
• Actual Study Completion Date: Feb 1, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Assess feasibility and acceptability of intervention [up to 3 months]

   Measured by proportion of intervention arm oncologists completing their intervention

Secondary Outcome Measures

1. Assess increase in number of empathic statements by oncologists [within 5 months]

   Measured by coding audio-recorded consultations post-intervention

2. Assess increase in number of questions related to their prognosis asked by patients [within 5 months]

   Measured by coding audio-recorded consultations post-intervention

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

1. 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Cancer Centre Singapore	Singapore		Singapore	169610

Sponsors and Collaborators

• Duke-NUS Graduate Medical School

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Chetna Malhotra, Assistant Professor, Duke-NUS Graduate Medical School
• ClinicalTrials.gov Identifier: NCT03671382
• Other Study ID Numbers: LCPC-IN
• First Posted: Sep 14, 2018
• Last Update Posted: Feb 8, 2019
• Last Verified: Feb 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Chetna Malhotra, Assistant Professor, Duke-NUS Graduate Medical School: Cancer

Study Results

No Results Posted as of Feb 8, 2019