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
  Purpose

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.


Condition Intervention Phase
Cancer
Chemotherapy
Other: Humor intervention
Other: Non-humor intervention (distraction)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Comedy in Chemotherapy (COMIC) Study

Resource links provided by NLM:


Further study details as provided by Queen's Medical Centre:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 50
Study Start Date: February 2007
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

    -

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01037933

Locations
United States, Hawaii
The Queen's Medical Center
Honolulu, Hawaii, United States, 96813
Sponsors and Collaborators
Queen's Medical Centre
Queen Emma Nursing Research Institute
University of Hawaii
Investigators
Principal Investigator: Hob Osterlund, RN, MS The Queen's Medical Center
Study Director: Brad Willcox, MD The Queen's Medical Center
  More Information

Additional Information:
No publications provided

Responsible Party: Hob Osterlund, APRN Clinical Nurse Specialist, Pain and Palliative Care Department, The Queen's Medical Center
ClinicalTrials.gov Identifier: NCT01037933     History of Changes
Other Study ID Numbers: RA2007020, Hob Osterlund
Study First Received: December 21, 2009
Last Updated: December 22, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Queen's Medical Centre:
Cancer
Humor
Distraction
Comedy
Chemotherapy

ClinicalTrials.gov processed this record on July 20, 2014