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

Study Overview
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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.

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

Conditions
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Female Reproductive Cancer

Intervention / Treatment
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* Procedure: mind-body intervention procedure
* Other: survey administration
* Procedure: quality-of-life assessment


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I (humorous followed by non-humorous movies)<br>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: mind-body intervention procedure<br>* Participate in media diversion with humorous and non-humorous movies<br>* Other names: mind-body interventions;Other: survey administration<br>* Ancillary studies<br>Procedure: quality-of-life assessment<br>* Ancillary studies<br>* Other names: quality of life assessment;|
| Experimental: Arm II (non-humorous followed by humorous movies)<br>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: mind-body intervention procedure<br>* Participate in media diversion with humorous and non-humorous movies<br>* Other names: mind-body interventions;Other: survey administration<br>* Ancillary studies<br>Procedure: quality-of-life assessment<br>* Ancillary studies<br>* Other names: quality of life assessment;|

What is the study measuring?
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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 |