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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
Sponsor:
Information provided by (Responsible Party):
Brian Roberts, The Cooper Health System

Brief 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.


Condition or disease Intervention/treatment Phase
Cancer Anxiety Compassion Empathy Other: Enhanced compassion video Other: Standard introduction video Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 470 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age ≥ 18 years
  • scheduled for an initial oncology consultation

Exclusion Criteria:

  • patients who do not have an active email address or are medically unable to complete the research questionnaire at the time of the initial cancer consultation.

Information from the National Library of Medicine

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


Contacts
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Contact: Brian Roberts 856-342-2352 roberts-brian-w@cooperhealth.edu

Locations
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United States, New Jersey
Cooper University Health Care Recruiting
Camden, New Jersey, United States, 08103
Contact: Brian Roberts       roberts-brian-w@cooperhealth.edu   
Sponsors and Collaborators
The Cooper Health System
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Brian Roberts, Study Director, The Cooper Health System
ClinicalTrials.gov Identifier: NCT04503681    
Other Study ID Numbers: 20-009
First Posted: August 7, 2020    Key Record Dates
Last Update Posted: June 23, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: After review and approval by our study data use committee, we will allow other researchers who submit to us a suitable protocol to have access to the complete de-identified datasets used and/or analyzed during the study, in comma separated value format together with a data dictionary.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Analytic Code

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Anxiety Disorders
Mental Disorders