Comedy in Chemotherapy (COMIC) Study

Cancer Clinical Trial

— COMIC  

Official title:

Comedy in Chemotherapy (COMIC) Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01037933
• Other study ID #: RA2007020
• Secondary ID: Hob Osterlund
• Status: Completed
• Phase: Phase 2
• First received: December 21, 2009
• Last updated: December 22, 2009
• Start date: February 2007
• Est. completion date: January 2009

Study information

• Verified date: December 2009
• Source: Queen's Medical Centre
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

1. Diagnosis of cancer

2. Receiving intravenous chemotherapy in the OPO clinic at QMC

3. Has a minimum appointment time in OPO of two hours

4. Age 21 or older

5. Speaks English

Exclusion Criteria:

1. Blind

2. Deaf

3. Diagnosis of head/neck cancer

4. Severe oral mucositis

5. Cognitively impaired

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cancer
• Chemotherapy

Intervention

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

Locations

Country	Name	City	State
United States	The Queen's Medical Center	Honolulu	Hawaii

Sponsors (3)

Lead Sponsor	Collaborator
Queen's Medical Centre	Queen Emma Nursing Research Institute, University of Hawaii

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To compare changes in symptoms related to cancer and chemotherapy after a humor vs. non-humor intervention		One day	No
Secondary	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	No

External Links

•   The Queen's Medical Center