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Comedy in Chemotherapy (COMIC) Study

NCT ID: NCT01037933

Last Updated: 2009-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2009-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cancer Chemotherapy

Keywords

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Cancer Humor Distraction Comedy Chemotherapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Humor intervention

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

Group Type ACTIVE_COMPARATOR

Humor intervention

Intervention Type OTHER

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

Non-humor intervention

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

Group Type ACTIVE_COMPARATOR

Non-humor intervention (distraction)

Intervention Type OTHER

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

Interventions

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Humor intervention

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

Intervention Type OTHER

Non-humor intervention (distraction)

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

Intervention Type OTHER

Eligibility Criteria

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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

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Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Queen Emma Nursing Research Institute

UNKNOWN

Sponsor Role collaborator

University of Hawaii

OTHER

Sponsor Role collaborator

Queen's Medical Center

OTHER

Sponsor Role lead

Responsible Party

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The Queen's Medical Center

Principal Investigators

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Hob Osterlund, RN, MS

Role: PRINCIPAL_INVESTIGATOR

The Queen's Medical Center

Brad Willcox, MD

Role: STUDY_DIRECTOR

The Queen's Medical Center

Locations

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The Queen's Medical Center

Honolulu, Hawaii, United States

Site Status

Countries

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United States

Related Links

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http://queens.org

The Queen's Medical Center

Other Identifiers

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Hob Osterlund

Identifier Type: -

Identifier Source: secondary_id

RA2007020

Identifier Type: -

Identifier Source: org_study_id