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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04503681
Other study ID # 20-009
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 1, 2021
Est. completion date October 31, 2023

Study information

Verified date November 2023
Source The Cooper Health System
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Patients diagnosed with cancer commonly have a high degree of anxiety during an initial oncology consultation, which may interfere with a patient's ability to retain information required to make informed treatment decisions. A previous study randomized breast cancer survivors (volunteers) to view either (a) a brief video depicting a standard initial consultation from an oncologist or (b) an identical consultation with the addition of compassionate statements from the oncologist, and found the compassionate statements reduced anxiety among the volunteers. However, it is currently unknown if watching a video containing compassionate statements from an oncologist prior to an actual initial oncology consultation will reduce anxiety among patients referred to a cancer center. The aim of this randomized control trial is to test if watching a brief video containing compassionate statements from an oncologist, compared to watching a standard introduction video, prior to an initial oncology consultation will reduce the degree of anxiety among patients referred to a cancer center. This is a prospective, randomized controlled clinical trial at an academic cancer center. The investigators will enroll adult patients scheduled for an initial oncology consultation. Subjects will be randomly assigned to receive a "standard introduction video" or "enhanced compassion video" for viewing prior to the initial oncology consultation. On arrival to the cancer center anxiety severity will be measured using the Hospital Anxiety and Depression scale (HADS). The HADS has two 7-item subscales (HADS Anxiety and HADS Depression) and is well-validated among oncology patients. Wilcoxon rank-sum test will be used to test for a difference in the HADS subscales between the two video groups.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Other:
Enhanced compassion video
Added five additional sentences to the standard introduction video. Those five sentences were compassion-focused statements. The compassionate statements added to the "enhanced compassion video" were based on the results of a recent systematic review of clinician compassionate behaviors, which found incorporating statements of support, acknowledgement, patient's perspective, emotion naming, and validation increased patient perception of compassion.
Standard introduction video
Standard introduction video sent to a new patient via email introducing the new patient to the cancer center prior to the initial consultation.

Locations

Country Name City State
United States Cooper University Health Care Camden New Jersey

Sponsors (1)

Lead Sponsor Collaborator
The Cooper Health System

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Anxiety subscale of the Hospital Anxiety and Depression scale (HADS) Seven item subscale. Each item is scored on a 4-point scale (0=not at all to 3=nearly all the time); thus, range from 0-21. Baseline (on arrival to the cancer center for an initial oncology consultant).
Secondary Depression subscale of the Hospital Anxiety and Depression scale Seven item subscale. Each item is scored on a 4-point scale (0=not at all to 3=nearly all the time); thus, range from 0-21. Baseline (on arrival to the cancer center for an initial oncology consultant).
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