Comedy in Chemotherapy (COMIC) Study

Queen's Medical Center50 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Cancer Chemotherapy

Interventions

Humor interventionOTHER

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

Non-humor intervention (distraction)OTHER

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

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

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 \-

Locations (1)

The Queen's Medical Center

Honolulu, Hawaii, United States

Outcomes

Primary Outcomes

To compare changes in symptoms related to cancer and chemotherapy after a humor vs. non-humor intervention

Time frame: One day

Secondary Outcomes

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

Data from ClinicalTrials.gov

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