Media Diversion in Improving Quality of Life in Patients With Recurrent Gynecologic Cancers Receiving Chemotherapy

NCT ID: NCT01901835

Last Updated: 2019-11-19

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

NA

Total Enrollment

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-12

Study Completion Date

2017-02-08

Brief Summary

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This randomized clinical trial studies media diversion in improving quality of life in patients with recurrent gynecologic cancers receiving chemotherapy. Media diversion may improve mood and quality of life in patients having cancer treatment.

Detailed Description

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PRIMARY OBJECTIVES:

I. To analyze the impact of a media-based intervention on patient mood during the receipt of chemotherapy for recurrent gynecologic cancers.

OUTLINE: are randomized to 1 of 2 arms.

ARM I: Participants are provided headphones and a tablet and choose among a selection of humorous movies. Upon the third course of chemotherapy, participants are provided a selection of non-humorous movies.

ARM II: Participants are provided headphones and a tablet and choose among a selection of non-humorous movies. Upon the third course of chemotherapy, participants are provided a selection of humorous movies.

Conditions

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Female Reproductive Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Investigators

Study Groups

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Arm I (humorous followed by non-humorous movies)

Participants are provided headphones and a tablet and choose among a selection of humorous movies. Upon the third course of chemotherapy, participants are provided a selection of non-humorous movies.

Group Type EXPERIMENTAL

mind-body intervention procedure

Intervention Type PROCEDURE

Participate in media diversion with humorous and non-humorous movies

survey administration

Intervention Type OTHER

Ancillary studies

quality-of-life assessment

Intervention Type PROCEDURE

Ancillary studies

Arm II (non-humorous followed by humorous movies)

Participants are provided headphones and a tablet and choose among a selection of non-humorous movies. Upon the third course of chemotherapy, participants are provided a selection of humorous movies.

Group Type EXPERIMENTAL

mind-body intervention procedure

Intervention Type PROCEDURE

Participate in media diversion with humorous and non-humorous movies

survey administration

Intervention Type OTHER

Ancillary studies

quality-of-life assessment

Intervention Type PROCEDURE

Ancillary studies

Interventions

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mind-body intervention procedure

Participate in media diversion with humorous and non-humorous movies

Intervention Type PROCEDURE

survey administration

Ancillary studies

Intervention Type OTHER

quality-of-life assessment

Ancillary studies

Intervention Type PROCEDURE

Other Intervention Names

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mind-body interventions quality of life assessment

Eligibility Criteria

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Inclusion Criteria

* Subjects with pathologically-proven gynecologic malignancies
* Subjects who have previously completed primary treatment for a gynecologic malignancy
* Patients receiving chemotherapy for a recurrent gynecologic cancer at the University of Wisconsin-Madison Carbone Cancer Center (UWCCC)
* Patients must be English speaking
* Patients must have the ability to use audio media and read and understand written English

Exclusion Criteria

* Patients unable to use audio or video media due to auditory or ocular dysfunction
* Patients unable to read written English
* Patients who are prisoners or incarcerated
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stephen Rose

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

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University of Wisconsin Hospital and Clinics

Madison, Wisconsin, United States

Site Status

Countries

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United States

Related Links

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https://cancer.wisc.edu/

University of Wisconsin Carbone Cancer Center

Other Identifiers

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NCI-2013-01284

Identifier Type: REGISTRY

Identifier Source: secondary_id

2013-0618

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA014520

Identifier Type: NIH

Identifier Source: secondary_id

View Link

A532820

Identifier Type: OTHER

Identifier Source: secondary_id

SMPH/OBSTET & GYNECOL/

Identifier Type: OTHER

Identifier Source: secondary_id

UW13037

Identifier Type: -

Identifier Source: org_study_id

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