NCT01037933

Comedy in Chemotherapy (COMIC) Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Queen's Medical Center · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cancer
• Chemotherapy

Interventions

Type	Name	Description
OTHER	Humor intervention	A 45-minute humorous DVD ("Bananas Bunch") using a portable DVD player.
OTHER	Non-humor intervention (distraction)	A 45-minute non-humorous DVD ("The A to Z of Steam Railways") using a portable DVD player

Timeline

• Start date: 2007-02-01
• Primary completion: 2009-01-01
• Completion: 2009-01-01
• First posted: 2009-12-23
• Last updated: 2009-12-23

Locations

1 site across 1 country: United States