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Media Diversion in Improving Quality of Life in Patients With Recurrent Gynecologic Cancers Receiving Chemotherapy

14. november 2019 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

67

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Wisconsin
      • Madison, Wisconsin, Forenede Stater, 53792
        • University of Wisconsin Hospital and Clinics

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Procedure: livskvalitetsvurdering
Hjælpestudier
Andre navne:
  • livskvalitetsvurdering
Andet: undersøgelsesadministration
Hjælpestudier
Procedure: mind-body intervention procedure
Participate in media diversion with humorous and non-humorous movies
Andre navne:
  • sind-krop interventioner
Eksperimentel: 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.
Procedure: livskvalitetsvurdering
Hjælpestudier
Andre navne:
  • livskvalitetsvurdering
Andet: undersøgelsesadministration
Hjælpestudier
Procedure: mind-body intervention procedure
Participate in media diversion with humorous and non-humorous movies
Andre navne:
  • sind-krop interventioner

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Wisconsin, Madison

Samarbejdspartnere

National Cancer Institute (NCI)

Efterforskere

  • Ledende efterforsker: Stephen Rose, University of Wisconsin, Madison

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

12. februar 2014

Primær færdiggørelse (Faktiske)

24. maj 2016

Studieafslutning (Faktiske)

8. februar 2017

Datoer for studieregistrering

Først indsendt

12. juli 2013

Først indsendt, der opfyldte QC-kriterier

12. juli 2013

Først opslået (Skøn)

17. juli 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

19. november 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. november 2019

Sidst verificeret

1. marts 2017

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • UW13037
  • P30CA014520 (U.S. NIH-bevilling/kontrakt)
  • A532820 (Anden identifikator: UW Madison)
  • NCI-2013-01284 (Registry Identifier: NCI Trial ID)
  • 2013-0618 (Anden identifikator: Institutional Review Board)
  • SMPH/OBSTET & GYNECOL/ (Anden identifikator: UW Madison)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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Betingelser

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Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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