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

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

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.

Study Overview

• Status: Completed
• Conditions: Female Reproductive Cancer
• Intervention / Treatment: Procedure: quality-of-life assessment; Other: survey administration; Procedure: mind-body intervention procedure

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 67
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • University of Wisconsin Hospital and Clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: quality-of-life assessment; Ancillary studies; Other Names: quality of life assessment; Other: survey administration; Ancillary studies; Procedure: mind-body intervention procedure; Participate in media diversion with humorous and non-humorous movies; Other Names: mind-body interventions
Experimental: 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.	Procedure: quality-of-life assessment; Ancillary studies; Other Names: quality of life assessment; Other: survey administration; Ancillary studies; Procedure: mind-body intervention procedure; Participate in media diversion with humorous and non-humorous movies; Other Names: mind-body interventions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Stephen Rose, University of Wisconsin, Madison

Publications and helpful links

Helpful Links

• University of Wisconsin Carbone Cancer Center

Study record dates

Study Major Dates

• Study Start: February 12, 2014
• Primary Completion (Actual): May 24, 2016
• Study Completion (Actual): February 8, 2017

Study Registration Dates

• First Submitted: July 12, 2013
• First Submitted That Met QC Criteria: July 12, 2013
• First Posted (Estimate): July 17, 2013

Study Record Updates

• Last Update Posted (Actual): November 19, 2019
• Last Update Submitted That Met QC Criteria: November 14, 2019
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: UW13037; P30CA014520 (U.S. NIH Grant/Contract); A532820 (Other Identifier: UW Madison); NCI-2013-01284 (Registry Identifier: NCI Trial ID); 2013-0618 (Other Identifier: Institutional Review Board); SMPH/OBSTET & GYNECOL/ (Other Identifier: UW Madison)