CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 374 enrolled
Drug / intervention
Enhanced compassion video +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04503681
NCT04503681N/ACompleted

A Pre-consultation Compassion Intervention to Reduce Anxiety Among Patients Referred to a Cancer Center

The Cooper Health System·interventional·Posted Aug 7, 2020·Updated Nov 21, 2024

In Brief

A clinical study evaluating Enhanced compassion video and Standard introduction video for Cancer and 3 related conditions. Completed, enrolled 374 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedAug 7, 2020
Enrollment StartJun 1, 2021
Primary CompletionOct 31, 2023
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 5.9 years ago

Interventions

Enhanced compassion videoother

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 videoother

Standard introduction video sent to a new patient via email introducing the new patient to the cancer center prior to the initial consultation.