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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2013-01284 | Registry Identifier | NCI Trial ID | |
| 2013-0618 | Other Identifier | Institutional Review Board | |
| P30CA014520 | U.S. NIH Grant/Contract | View source | |
| A532820 | Other Identifier | UW Madison | |
| SMPH/OBSTET & GYNECOL/ | Other Identifier | UW Madison |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mind-body intervention procedure | Procedure | Participate in media diversion with humorous and non-humorous movies |
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| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephen Rose | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin Hospital and Clinics | Madison | Wisconsin | 53792 | United States |
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| Label | URL |
|---|---|
| University of Wisconsin Carbone Cancer Center | View source |
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|
| survey administration | Other | Ancillary studies |
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| quality-of-life assessment | Procedure | Ancillary studies |
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| 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 |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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