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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03671382
Other study ID # LCPC-IN
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 31, 2018
Est. completion date February 1, 2019

Study information

Verified date February 2019
Source Duke-NUS Graduate Medical School
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 104
Est. completion date February 1, 2019
Est. primary completion date February 1, 2019
Accepts healthy volunteers No
Gender All
Age group 21 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Singapore National Cancer Centre Singapore Singapore

Sponsors (1)

Lead Sponsor Collaborator
Duke-NUS Graduate Medical School

Country where clinical trial is conducted

Singapore, 

Outcome

Type Measure Description Time frame Safety issue
Primary Assess feasibility and acceptability of intervention Measured by proportion of intervention arm oncologists completing their intervention up to 3 months
Secondary Assess increase in number of empathic statements by oncologists Measured by coding audio-recorded consultations post-intervention within 5 months
Secondary Assess increase in number of questions related to their prognosis asked by patients Measured by coding audio-recorded consultations post-intervention within 5 months
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