NCT01901835

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 12, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 17, 2013

Completed
7 months until next milestone

Study Start

First participant enrolled

February 12, 2014

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 24, 2016

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 8, 2017

Completed
Last Updated

November 19, 2019

Status Verified

March 1, 2017

Enrollment Period

2.3 years

First QC Date

July 12, 2013

Last Update Submit

November 14, 2019

Conditions

Female Reproductive Cancer

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Humor Styles Questionnaire (HSQ) total score

    Up to day 1 of course 3 of chemotherapy

  • Brief Fatigue Inventory (BFI) total score

    Up to day 1 of course 3 of chemotherapy

  • Ease of use (EoS) score

    Up to day 1 of course 3 of chemotherapy

  • Quality of materials (QOM) score

    Up to day 1 of course 3 of chemotherapy

Study Arms (2)

Arm I (humorous followed by non-humorous movies)

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.

Procedure: mind-body intervention procedureOther: survey administrationProcedure: quality-of-life assessment

Arm II (non-humorous followed by humorous movies)

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.

Procedure: mind-body intervention procedureOther: survey administrationProcedure: quality-of-life assessment

Interventions

mind-body intervention procedurePROCEDURE

Participate in media diversion with humorous and non-humorous movies

Also known as: mind-body interventions
Arm I (humorous followed by non-humorous movies)Arm II (non-humorous followed by humorous movies)
survey administrationOTHER

Ancillary studies

Arm I (humorous followed by non-humorous movies)Arm II (non-humorous followed by humorous movies)
quality-of-life assessmentPROCEDURE

Ancillary studies

Also known as: quality of life assessment
Arm I (humorous followed by non-humorous movies)Arm II (non-humorous followed by humorous movies)

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, 53792, United States

Location

Related Links

MeSH Terms

Interventions

Mind-Body Therapies

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Officials

  • Stephen Rose

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 12, 2013

First Posted

July 17, 2013

Study Start

February 12, 2014

Primary Completion

May 24, 2016

Study Completion

February 8, 2017

Last Updated

November 19, 2019

Record last verified: 2017-03

Locations

US(1)