Comedy in Chemotherapy (COMIC) Study
COMIC
2 other identifiers
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 cancer
Started Feb 2007
Shorter than P25 for phase_2 cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2009
CompletedFirst Submitted
Initial submission to the registry
December 21, 2009
CompletedFirst Posted
Study publicly available on registry
December 23, 2009
CompletedDecember 23, 2009
December 1, 2009
1.9 years
December 21, 2009
December 22, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To compare changes in symptoms related to cancer and chemotherapy after a humor vs. non-humor intervention
One day
Secondary Outcomes (1)
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
Study Arms (2)
Humor intervention
ACTIVE COMPARATORA 45-minute humorous DVD ("Bananas Bunch") using a portable DVD player.
Non-humor intervention
ACTIVE COMPARATORA 45-minute non-humorous DVD "The A to Z of Steam Railways" using a portable DVD player.
Interventions
A 45-minute humorous DVD ("Bananas Bunch") using a portable DVD player.
A 45-minute non-humorous DVD ("The A to Z of Steam Railways") using a portable DVD player
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Blind
- Deaf
- Diagnosis of head/neck cancer
- Severe oral mucositis
- Cognitively impaired
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Queen's Medical Centerlead
- Queen Emma Nursing Research Institutecollaborator
- University of Hawaiicollaborator
Study Sites (1)
The Queen's Medical Center
Honolulu, Hawaii, 96813, United States
Related Links
MeSH Terms
Conditions
Study Officials
- PRINCIPAL INVESTIGATOR
Hob Osterlund, RN, MS
The Queen's Medical Center
- STUDY DIRECTOR
Brad Willcox, MD
The Queen's Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
December 21, 2009
First Posted
December 23, 2009
Study Start
February 1, 2007
Primary Completion
January 1, 2009
Study Completion
January 1, 2009
Last Updated
December 23, 2009
Record last verified: 2009-12