Cancer Clinical Trial
Official title:
Comedy in Chemotherapy (COMIC) Study
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. ;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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