Comedy in Chemotherapy (COMIC) Study

This study has been completed.

Sponsor:

Collaborators:

Queen Emma Nursing Research Institute

University of Hawaii

Information provided by:

Queen's Medical Centre

ClinicalTrials.gov Identifier:

NCT01037933

First received: December 21, 2009

Last updated: December 22, 2009

Last verified: December 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

December 21, 2009

Last Updated Date

December 22, 2009

Start Date ^ICMJE

February 2007

Primary Completion Date

January 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

To compare changes in symptoms related to cancer and chemotherapy after a humor vs. non-humor intervention [ Time Frame: One day ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01037933 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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. [ Time Frame: One day ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Comedy in Chemotherapy (COMIC) Study

Official Title ^ICMJE

Comedy in Chemotherapy (COMIC) Study

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

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

Condition ^ICMJE

Cancer
Chemotherapy

Intervention ^ICMJE

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

Study Arm (s)

Active Comparator: Humor intervention
A 45-minute humorous DVD ("Bananas Bunch") using a portable DVD player.

Intervention: Other: Humor intervention
Active Comparator: Non-humor intervention
A 45-minute non-humorous DVD "The A to Z of Steam Railways" using a portable DVD player.

Intervention: Other: Non-humor intervention (distraction)

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

January 2009

Primary Completion Date

January 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

-

Gender

Both

Ages

21 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01037933

Other Study ID Numbers ^ICMJE

RA2007020, Hob Osterlund

Has Data Monitoring Committee

Responsible Party

Hob Osterlund, APRN Clinical Nurse Specialist, Pain and Palliative Care Department, The Queen's Medical Center

Study Sponsor ^ICMJE

Queen's Medical Centre

Collaborators ^ICMJE

Queen Emma Nursing Research Institute
University of Hawaii

Investigators ^ICMJE

Principal Investigator:	Hob Osterlund, RN, MS	The Queen's Medical Center
Study Director:	Brad Willcox, MD	The Queen's Medical Center

Information Provided By

Queen's Medical Centre

Verification Date

December 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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