Female Reproductive CancerNCT01901835
Media Diversion in Improving Quality of Life in Patients With Recurrent Gynecologic Cancers Receiving Chemotherapy
A study testing mind-body intervention procedure, survey administration and quality-of-life assessment in people with Female Reproductive Cancer, run by University of Wisconsin, Madison at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Female Reproductive Cancer
- What is being tested?
- mind-body intervention procedure, survey administration and quality-of-life assessment
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Feb 2014to 8 Feb 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792
About this study
Official title: 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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
- Conditions
- Female Reproductive Cancer
- Being tested
- mind-body intervention procedure, survey administration, quality-of-life assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mind-body intervention procedureProcedure or surgery
Also called mind-body interventions
Participate in media diversion with humorous and non-humorous movies
survey administrationOther
Ancillary studies
quality-of-life assessmentProcedure or surgery
Also called quality of life assessment
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: mind-body intervention procedure; Other: survey administration; Procedure: 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. Receives: Procedure: mind-body intervention procedure; Other: survey administration; Procedure: quality-of-life assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to day 1 of course 3 of chemotherapy
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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
Measured: 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
Measured: Up to day 1 of course 3 of chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2013 (estimated)
- Study start12 Feb 2014
- Primary completion24 May 2016
- Study completion8 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Female Reproductive CancerStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Stephen Rose, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01901835
- Sponsor's protocol ID
- UW13037
- Other IDs
- NCI-2013-01284, 2013-0618, P30CA014520, A532820, SMPH/OBSTET & GYNECOL/
- Status last verified
- Mar 2017
- First submitted
- 12 Jul 2013
- Last updated
- 19 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a Media Diversion on Quality of Life in Patients Receiving Chemotherapy for Recurrent Gynecologic Cancers
- ClinicalTrials.gov ID
- NCT01901835
- Acronym / sponsor ID
- UW13037
- Conditions
- Female Reproductive Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 12 Feb 2014
- Primary completion
- 24 May 2016 (actual)
- Study completion
- 8 Feb 2017 (actual)
- First posted
- 17 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
PRIMARY OBJECTIVES:
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (humorous followed by non-humorous movies) | Experimental | Procedure: mind-body intervention procedure, Other: survey administration, Procedure: quality-of-life assessmentParticipants 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 (non-humorous followed by humorous movies) | Experimental | Procedure: mind-body intervention procedure, Other: survey administration, Procedure: quality-of-life assessmentParticipants 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 may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mind-body intervention procedureAlso: mind-body interventionsParticipate in media diversion with humorous and non-humorous movies | Procedure or surgery | Arm I (humorous followed by non-humorous movies), Arm II (non-humorous followed by humorous movies) |
| survey administrationAncillary studies | Other | Arm I (humorous followed by non-humorous movies), Arm II (non-humorous followed by humorous movies) |
| quality-of-life assessmentAlso: quality of life assessmentAncillary studies | Procedure or surgery | Arm I (humorous followed by non-humorous movies), Arm II (non-humorous followed by humorous movies) |
Primary outcome
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.
4 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2019.
- University of Wisconsin Carbone Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen Rose principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mind-body intervention procedure, survey administration and quality-of-life assessment in people with Female Reproductive Cancer, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2019; AzTrials last refreshed its copy on 8 Nov 2026.