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

Female Reproductive Cancer Clinical Trial

Official title:

The Effects of a Media Diversion on Quality of Life in Patients Receiving Chemotherapy for Recurrent Gynecologic Cancers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01901835
• Other study ID #: UW13037
• Secondary ID: NCI-2013-0128420
• Status: Completed
• Phase: N/A
• Start date: February 12, 2014
• Est. completion date: February 8, 2017

Study information

• Verified date: March 2017
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: February 8, 2017
• Est. primary completion date: May 24, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Female Reproductive Cancer

Intervention

Procedure:
• mind-body intervention procedure
Participate in media diversion with humorous and non-humorous movies

Other:
• survey administration
Ancillary studies

Procedure:
• quality-of-life assessment
Ancillary studies

Locations

Country	Name	City	State
United States	University of Wisconsin Hospital and Clinics	Madison	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient-reported mood using the Positive and Negative Affect Scale-Expanded Form (PANAS-X) instrument	Summarized in terms of means, standard deviations and ranges, stratified by group and assessment time point. Absolute and percentage changes from baseline within each group will be calculated and reported in terms of means and the corresponding 95% confidence intervals. Changes from baseline will be evaluated using a paired t-test. A Grizzle model for a 2 X 2 cross-over design will be used to compare changes in PANAS-X positive and negative affect scores between groups.	Up to day 1 of course 3 of chemotherapy
Secondary	Humor Styles Questionnaire (HSQ) total score	Summarized in terms of means, standard deviations and ranges, stratified by group and assessment time point. Absolute and percentage changes from baseline within each group will be calculated and reported in terms of means and the corresponding 95% confidence intervals. Changes from baseline will be evaluated using a paired t-test. A Grizzle model for a 2 X 2 cross-over design will be used to compare changes in HSQ total scores between groups.	Up to day 1 of course 3 of chemotherapy
Secondary	Brief Fatigue Inventory (BFI) total score	Summarized in terms of means, standard deviations and ranges, stratified by group and assessment time point. Absolute and percentage changes from baseline within each group will be calculated and reported in terms of means and the corresponding 95% confidence intervals. Changes from baseline will be evaluated using a paired t-test. A Grizzle model for a 2 X 2 cross-over design will be used to compare changes in BFI total scores between groups.	Up to day 1 of course 3 of chemotherapy
Secondary	Ease of use (EoS) score	Assessed with a Likert scale at the completion of the subject's participation to understand how the intervention may be improved should results of this study favor implementation into standard clinical procedure for future patients. Summarized in terms of medians and ranges, stratified by group and assessment time point. Changes from baseline within each group will be evaluated using a nonparametric Wilcoxon Signed Rank test	Up to day 1 of course 3 of chemotherapy
Secondary	Quality of materials (QOM) score	Assessed with a Likert scale at the completion of the subject's participation to understand how the intervention may be improved should results of this study favor implementation into standard clinical procedure for future patients. Summarized in terms of medians and ranges, stratified by group and assessment time point. Changes from baseline within each group will be evaluated using a nonparametric Wilcoxon Signed Rank test	Up to day 1 of course 3 of chemotherapy

External Links

•   University of Wisconsin Carbone Cancer Center