NCT03671382

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 31, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 2, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 14, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
Last Updated

February 8, 2019

Status Verified

February 1, 2019

Enrollment Period

6 months

First QC Date

September 2, 2018

Last Update Submit

February 6, 2019

Conditions

Keywords

Cancer

Outcome Measures

Primary Outcomes (1)

  • Assess feasibility and acceptability of intervention

    Measured by proportion of intervention arm oncologists completing their intervention

    up to 3 months

Secondary Outcomes (2)

  • Assess increase in number of empathic statements by oncologists

    within 5 months

  • Assess increase in number of questions related to their prognosis asked by patients

    within 5 months

Study Arms (2)

Intervention Arm

EXPERIMENTAL

Communication Training Program and Patient Prompt Sheet

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

Interventions

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.

Intervention Arm

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All consultants and senior residents/registrars in the Departments of Medical Oncology at National Cancer Centre, Singapore
  • Able to allow audio-recording during consultation
  • Age ≥ 21 years old
  • Patients who are consulting an oncologist who is participating in the study
  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cancer Centre Singapore

Singapore, 169610, Singapore

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Chetna Malhotra, MD, MPH

    Duke-NUS Graduate Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 2, 2018

First Posted

September 14, 2018

Study Start

July 31, 2018

Primary Completion

February 1, 2019

Study Completion

February 1, 2019

Last Updated

February 8, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations