Overview

This trial is active, not recruiting.

Condition female reproductive cancer
Treatments mind-body intervention procedure, survey administration, quality-of-life assessment
Sponsor University of Wisconsin, Madison
Collaborator National Cancer Institute (NCI)
Start date February 2014
End date May 2016
Trial size 67 participants
Trial identifier NCT01901835, 2013-0618, NCI-2013-01284, P30CA014520, UW13037

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking single blind (investigator)
Primary purpose supportive care
Arm
(Experimental)
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.
mind-body intervention procedure mind-body interventions
Participate in media diversion with humorous and non-humorous movies
survey administration
Ancillary studies
quality-of-life assessment quality of life assessment
Ancillary studies
(Experimental)
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.
mind-body intervention procedure mind-body interventions
Participate in media diversion with humorous and non-humorous movies
survey administration
Ancillary studies
quality-of-life assessment quality of life assessment
Ancillary studies

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
Humor Styles Questionnaire (HSQ) total score
time frame: Up to day 1 of course 3 of chemotherapy
Brief Fatigue Inventory (BFI) total score
time frame: Up to day 1 of course 3 of chemotherapy
Ease of use (EoS) score
time frame: Up to day 1 of course 3 of chemotherapy
Quality of materials (QOM) score
time frame: Up to day 1 of course 3 of chemotherapy

Eligibility Criteria

Female participants at least 18 years old.

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

Additional Information

Official title The Effects of a Media Diversion on Quality of Life in Patients Receiving Chemotherapy for Recurrent Gynecologic Cancers
Principal investigator Stephen Rose
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by University of Wisconsin, Madison.
Location data was received from the National Cancer Institute and was last updated in April 2016.