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Comedy in Chemotherapy (COMIC) Study

Q

Queen's Medical Center

Status and phase

Completed
Phase 2

Conditions

Chemotherapy
Cancer

Treatments

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

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

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)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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