Comedy in Chemotherapy (COMIC) Study

Study Overview
=================
Brief Summary
-----------------
Primary aims: To compare changes in (a) symptoms related to cancer and chemotherapy, (b) a marker of immune function (salivary immunoglobulin A), and (c) a hormonal marker of emotional stress (salivary cortisol) between two groups of patients who view a humorous or non-humorous DVD. Secondary aim: To describe the perception of patients, caregivers, and nurses regarding the overall intervention experience.

Detailed Description
-----------------
Patients were recruited from the Outpatient Oncology (OPO) clinic at QMC. After signing an informed consent, patients receiving intravenous chemotherapy were randomly assigned to view a 45-minute humorous DVD or non-humorous DVD. The following measurements were obtained before and after patients viewed the DVD: Edmonton Symptom Assessment Scale (ESAS) and the state portion of the Spielberger State-Trait Anxiety Index (STAI-S) to assess symptoms related to cancer and chemotherapy, salivary immunoglobulin A (IgA) to assess immune function and salivary cortisol to assess emotional stress. In addition, patients, caregivers, and nurses were asked open-ended questions after the intervention to ascertain their impression of the overall intervention experience. Multiple analysis of covariance (MANCOVA) were be used to analyze changes in ESAS, STAI-S, IgA and cortisol within and between the two groups.

Official Title
-----------------
Comedy in Chemotherapy (COMIC) Study

Conditions
-----------------
Cancer, Chemotherapy

Intervention / Treatment
-----------------
* Other: Humor intervention
* Other: Non-humor intervention (distraction)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of cancer Receiving intravenous chemotherapy in the OPO clinic at QMC Has a minimum appointment time in OPO of two hours Age 21 or older Speaks English Exclusion Criteria: Blind Deaf Diagnosis of head/neck cancer Severe oral mucositis Cognitively impaired -

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Humor intervention<br>A 45-minute humorous DVD (Bananas Bunch) using a portable DVD player. | Other: Humor intervention<br>* A 45-minute humorous DVD (Bananas Bunch) using a portable DVD player.<br>|
| Active Comparator: Non-humor intervention<br>A 45-minute non-humorous DVD The A to Z of Steam Railways using a portable DVD player. | Other: Non-humor intervention (distraction)<br>* A 45-minute non-humorous DVD (The A to Z of Steam Railways) using a portable DVD player<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare changes in symptoms related to cancer and chemotherapy after a humor vs. non-humor intervention |  | One day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare changes in a marker of immune function (salivary immunoglobulin A), and a hormonal marker of emotional stress (salivary cortisol) between two groups of patients who view a humorous or non-humorous DVD. |  | One day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cancer, Humor, Distraction, Comedy, Chemotherapy