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

Study design This study is a prospective, randomized, controlled, parallel-group clinical trial at a single university-based cancer center (MD Anderson Cancer Center at Cooper, Cooper University Health Care, Camden, New Jersey, USA). Potential subjects will be enrolled at the time of scheduling an initial cancer consultation. The Cooper University Hospital Institutional Review Board allowed alteration of the requirements of obtaining informed consent under 45 CFR 46.116(d) given the intervention was deemed no greater than minimal risk. 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." Emails will be sent to patients prior to obtaining informed consent to allow for viewing of the video prior to the initial oncology consultation and to keep the patients masked to the study hypotheses prior to the consultation. When the patients arrive to the MD Anderson 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.

Randomization and masking Patients will be randomly assigned to one of two groups, "standard introduction video" or "enhanced compassion video." An independent statistician will generate the group assignment sequence using a parallel design, 1:1 randomization schedule. Standard measures will be used to ensure appropriate concealment of group assignment. 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. Thus, the operators, investigators, and research statistician will be blinded to video allocation until after all study analyses have been completed.

Interventions As part of a currently ongoing clinical quality initiative at the study institution, when a new patient schedules an appointment for an initial cancer consultation the scheduling operator sends an email to the patient containing a link for a standard introduction video. For the purposes of this study a second "enhanced compassion video" was developed, which added five additional sentences to the standard introduction video. Those five sentences were compassion-focused statements. Both videos feature the same oncologist (i.e. Medical Director of MD Anderson Cancer Center at Cooper) and are identical aside from the additional compassionate 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.

Measurements and Data Collection After obtaining written informed consent a research questionnaire will be administered to patients at the cancer center prior to the initial cancer consultation. The questionnaire will assess the patients' perception of the video oncologist's compassion using the 5-item compassion measure, a previously validated patient-assessed measure of perceived compassion during patient care. Subject demographics, as well as clinical information pertaining to cancer diagnosis will be abstracted from the medical record.

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 subjects will be asked to complete the Hospital Anxiety and Depression scale (HADS). The HADS is a 14-item self-reported instrument that assesses anxiety and depressive symptoms in populations with medical conditions (both in- and out-patients). It has two 7-item subscales: HADS Anxiety and HADS Depression. Each item is scored on a 4-point scale (0=not at all to 3=nearly all the time); thus, each sub-scale can range from 0-21. The HADS has been extensively validated in oncology populations, and is a commonly used measure of anxiety and depression in oncology studies. The HADS Depression score will be analyzed as a secondary outcome. An additional secondary outcome measure will be the no-show rate for the initial consultation among each group. All data will be entered into Research Electronic Data Capture (REDCap), a secure, web-based application designed to support data capture for research studies, and export the data into Stata/SE 16.0 for Mac, StataCorp LP (College Station, TX, USA) for analysis.