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Completed

NCT Number: NCT01901835

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

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.

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Key information

Conditions

Female Reproductive Cancer

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, 53792, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

mind-body intervention procedure

Procedure

Participate in media diversion with humorous and non-humorous movies

Other names: mind-body interventions

Survey Administration

Other

Ancillary studies

quality-of-life assessment

Procedure

Ancillary studies

Other names: quality of life assessment

Primary outcomes

  1. Patient-reported mood using the Positive and Negative Affect Scale-Expanded Form (PANAS-X) instrument

    Time frame: Up to day 1 of course 3 of chemotherapy

    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.

Secondary outcomes

  1. Humor Styles Questionnaire (HSQ) total score

    Time frame: Up to day 1 of course 3 of chemotherapy

    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.

  2. Brief Fatigue Inventory (BFI) total score

    Time frame: Up to day 1 of course 3 of chemotherapy

    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.

  3. Ease of use (EoS) score

    Time frame: Up to day 1 of course 3 of chemotherapy

    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

  4. Quality of materials (QOM) score

    Time frame: Up to day 1 of course 3 of chemotherapy

    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

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Jul 17, 2013
Registry last updated
Nov 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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