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Comedy in Chemotherapy (COMIC) Study

Comedy in Chemotherapy (COMIC) Study

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01037933
Acronym
COMIC
Enrollment
50
Registered
2009-12-23
Start date
2007-02-28
Completion date
2009-01-31
Last updated
2009-12-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer, Chemotherapy

Keywords

Cancer, Humor, Distraction, Comedy, Chemotherapy

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.

Interventions

OTHERHumor intervention

A 45-minute humorous DVD (Bananas Bunch) using a portable DVD player.

OTHERNon-humor intervention (distraction)

A 45-minute non-humorous DVD (The A to Z of Steam Railways) using a portable DVD player

Sponsors

Queen Emma Nursing Research Institute
CollaboratorUNKNOWN
University of Hawaii
CollaboratorOTHER
Queen's Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No

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 \-

Design outcomes

Primary

MeasureTime frame
To compare changes in symptoms related to cancer and chemotherapy after a humor vs. non-humor interventionOne day

Secondary

MeasureTime 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.One day

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026