Pre-consultation Compassion Among Patients Referred to a Cancer Center
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|ClinicalTrials.gov Identifier: NCT04503681|
Recruitment Status : Recruiting
First Posted : August 7, 2020
Last Update Posted : June 23, 2021
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.
|Condition or disease||Intervention/treatment||Phase|
|Cancer Anxiety Compassion Empathy||Other: Enhanced compassion video Other: Standard introduction video||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||470 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Pre-consultation Compassion Intervention to Reduce Anxiety Among Patients Referred to a Cancer Center|
|Actual Study Start Date :||June 1, 2021|
|Estimated Primary Completion Date :||July 2022|
|Estimated Study Completion Date :||August 2022|
|Active Comparator: Standard introduction video||
Other: 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.
|Experimental: Enhanced compassion video||
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.
- Anxiety subscale of the Hospital Anxiety and Depression scale (HADS) [ Time Frame: Baseline (on arrival to the cancer center for an initial oncology consultant). ]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.
- Depression subscale of the Hospital Anxiety and Depression scale [ Time Frame: Baseline (on arrival to the cancer center for an initial oncology consultant). ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04503681
|Contact: Brian Robertsemail@example.com|
|United States, New Jersey|
|Cooper University Health Care||Recruiting|
|Camden, New Jersey, United States, 08103|
|Contact: Brian Roberts firstname.lastname@example.org|