Media Diversion in Improving Quality of Life in Patients With Recurrent Gynecologic Cancers Receiving Chemotherapy
14 november 2019 uppdaterad av: University of Wisconsin, Madison
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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
67
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Wisconsin
-
Madison, Wisconsin, Förenta staterna, 53792
- University of Wisconsin Hospital and Clinics
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Kvinna
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Arm I (humorous followed by non-humorous movies)
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.
|
Sidostudier
Andra namn:
Sidostudier
Participate in media diversion with humorous and non-humorous movies
Andra namn:
|
|
Experimentell: Arm II (non-humorous followed by humorous movies)
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.
|
Sidostudier
Andra namn:
Sidostudier
Participate in media diversion with humorous and non-humorous movies
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Patient-reported mood using the Positive and Negative Affect Scale-Expanded Form (PANAS-X) instrument
Tidsram: 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.
|
Up to day 1 of course 3 of chemotherapy
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Humor Styles Questionnaire (HSQ) total score
Tidsram: 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.
|
Up to day 1 of course 3 of chemotherapy
|
|
Brief Fatigue Inventory (BFI) total score
Tidsram: 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.
|
Up to day 1 of course 3 of chemotherapy
|
|
Ease of use (EoS) score
Tidsram: 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
|
Up to day 1 of course 3 of chemotherapy
|
|
Quality of materials (QOM) score
Tidsram: 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
|
Up to day 1 of course 3 of chemotherapy
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Stephen Rose, University of Wisconsin, Madison
Publikationer och användbara länkar
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Användbara länkar
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
12 februari 2014
Primärt slutförande (Faktisk)
24 maj 2016
Avslutad studie (Faktisk)
8 februari 2017
Studieregistreringsdatum
Först inskickad
12 juli 2013
Först inskickad som uppfyllde QC-kriterierna
12 juli 2013
Första postat (Uppskatta)
17 juli 2013
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
19 november 2019
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
14 november 2019
Senast verifierad
1 mars 2017
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- UW13037
- P30CA014520 (U.S.S. NIH-anslag/kontrakt)
- A532820 (Annan identifierare: UW Madison)
- NCI-2013-01284 (Registeridentifierare: NCI Trial ID)
- 2013-0618 (Annan identifierare: Institutional Review Board)
- SMPH/OBSTET & GYNECOL/ (Annan identifierare: UW Madison)
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .