Comedy in Chemotherapy (COMIC) Study (COMIC)

December 22, 2009 updated by: Queen's Medical Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Hawaii
      • Honolulu, Hawaii, United States, 96813
        • The Queen's Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
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.
Time Frame: One day
One day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Queen's Medical Center

Collaborators

University of Hawaii
Queen Emma Nursing Research Institute

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Primary Completion (Actual)

January 1, 2009

Study Completion (Actual)

January 1, 2009

Study Registration Dates

First Submitted

December 21, 2009

First Submitted That Met QC Criteria

December 22, 2009

First Posted (Estimate)

December 23, 2009

Study Record Updates

Last Update Posted (Estimate)

December 23, 2009

Last Update Submitted That Met QC Criteria

December 22, 2009

Last Verified

December 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • RA2007020
  • Hob Osterlund

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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