A Pre-consultation Compassion Intervention to Reduce Anxiety Among Patients Referred to a Cancer Center
Phase: NA
Conditions: Cancer, Anxiety, Compassion, Empathy
Sponsor: The Cooper Health System

A pre-consultation compassion video to reduce anxiety among patients referred 
to a cancer center: a randomized control trial 
 
Protocol 
 
4/18/21 
 
 
 
 
 
 
 

Participants 
We will enroll adult patients scheduled for an initial cancer consultation at MD Anderson Cancer 
Center at Cooper. Inclusion criteria include: 1) age ≥ 18 years; 2) scheduled for an initial cancer 
consultation. We will exclude 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. 
 
Intervention, randomization and masking 
All new adult patients scheduled for an initial cancer consultation at MD Anderson Cancer 
Center at Cooper will be randomized to receive an email containing a link for either the 
“standard introduction video” or the “enhanced compassion video.” Subjects will receive either 
an information only standard introduction video (76 seconds) or an enhanced compassion video 
(107 seconds). The two videos featured the same oncologist (i.e. Medical Director of the cancer 
center) and are identical except the enhanced compassion video contains five additional 
compassion-focused statements. An independent statistician will generate the group 
assignment sequence using a parallel design, 1:1 simple randomization schedule. The 
randomization assignments will be kept in a sequential list and maintained in the scheduling 
operator office. At the time of scheduling an initial consultation, appointment operators will 
identify the next assignment in the series, which will be labeled either “Video A” or “Video B.” 
The operators will then send the appropriate email containing a link to a website for the 
matching video. The independent statistician will maintain the code link for the videos. When the 
patients arrive to the Cancer Center waiting room for his/her initial cancer consultation they will 
be approached by research staff to obtain written informed consent to complete the research 
questionnaire and for use of data. 
 
 
 

Outcome measures 
The primary outcome measure will be anxiety severity on arrival to the cancer center for the 
initial consultation. As part of the research questionnaire patients will be asked to complete the 
Hospital Anxiety and Depression scale (HADS). The HADS Depression score will be analyzed 
as a secondary outcome. 
 
Statistical analysis: 
We will use the Wilcoxon rank-sum test to test for a difference in the HADS anxiety scale 
between the two video groups and quantile regression to report the median difference with 95% 
CI. For our secondary outcome measure we will repeat the same analyses using the HADS 
depression scale in place of the HADS anxiety scale. We will perform all analyses using 
intention to treat principle.