Media Diversion in Improving Quality of Life in Patients With Recurrent Gynecologic Cancers Receiving Chemotherapy
14. november 2019 oppdatert 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.
Studieoversikt
Status
Fullført
Forhold
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Faktiske)
67
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Wisconsin
-
Madison, Wisconsin, Forente stater, 53792
- University of Wisconsin Hospital and Clinics
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Hunn
Beskrivelse
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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.
|
Hjelpestudier
Andre navn:
Hjelpestudier
Participate in media diversion with humorous and non-humorous movies
Andre navn:
|
|
Eksperimentell: 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.
|
Hjelpestudier
Andre navn:
Hjelpestudier
Participate in media diversion with humorous and non-humorous movies
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Patient-reported mood using the Positive and Negative Affect Scale-Expanded Form (PANAS-X) instrument
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Humor Styles Questionnaire (HSQ) total score
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Stephen Rose, University of Wisconsin, Madison
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Hjelpsomme linker
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
12. februar 2014
Primær fullføring (Faktiske)
24. mai 2016
Studiet fullført (Faktiske)
8. februar 2017
Datoer for studieregistrering
Først innsendt
12. juli 2013
Først innsendt som oppfylte QC-kriteriene
12. juli 2013
Først lagt ut (Anslag)
17. juli 2013
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
19. november 2019
Siste oppdatering sendt inn som oppfylte QC-kriteriene
14. november 2019
Sist bekreftet
1. mars 2017
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- UW13037
- P30CA014520 (U.S. NIH-stipend/kontrakt)
- A532820 (Annen identifikator: UW Madison)
- NCI-2013-01284 (Registeridentifikator: NCI Trial ID)
- 2013-0618 (Annen identifikator: Institutional Review Board)
- SMPH/OBSTET & GYNECOL/ (Annen identifikator: UW Madison)
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .