Comedy in Chemotherapy (COMIC) Study

Queen's Medical Center

Status and phase: Completed; Phase 2

Conditions: Chemotherapy; Cancer

Treatments: Other: Humor intervention; Other: Non-humor intervention (distraction)

Study type: Interventional

Funder types: Other

Identifiers

NCT01037933

RA2007020

Hob Osterlund

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Humor intervention

Active Comparator group

Description:

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

Treatment:

Other: Humor intervention

Non-humor intervention

Active Comparator group

Description:

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

Treatment:

Other: Non-humor intervention (distraction)