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Completed

NCT Number: NCT01037933

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.

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Key information

Conditions

Cancer Chemotherapy Neoplasms

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The Queen's Medical Center

Honolulu, Hawaii, 96813, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of cancer
  • Receiving intravenous chemotherapy in the OPO clinic at QMC
  • Has a minimum appointment time in OPO of two hours
  • Age 21 or older
  • Speaks English

Exclusion criteria

  • Blind
  • Deaf
  • Diagnosis of head/neck cancer
  • Severe oral mucositis
  • Cognitively impaired

-

Treatment and study plan

Humor intervention

Other

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

Primary outcomes

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

    Time frame: One day

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Queen's Medical Center

Other

Collaborators

  • Queen Emma Nursing Research Institute
  • University of Hawaii

Registry information

Acronym: COMIC

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Dec 23, 2009
Registry last updated
Dec 23, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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