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Improving Symptom Self-management in Adolescents & Young Adults With Cancer (CSCAT2)

20 december 2017 uppdaterad av: Virginia Commonwealth University
This study evaluates the use of the Computerized Symptom Capture Tool (C-SCAT), which creates an image of the symptoms the participant is experiencing, for improving symptom self-management in adolescents and young adults with cancer. In this one-group trial, participants will complete the C-SCAT and use it during two clinic visits with their oncology providers.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

Unrelieved symptoms lead to poorer quality of life for adolescents and young adults (AYAs) with cancer. Strategies are needed to help AYAs manage symptoms. The investigators developed the Computerized Symptom Capture Tool (C-SCAT), a novel way to assess symptoms where AYAs create a picture of their symptoms using images and text on an iPad app. The resulting image shows symptoms/symptom clusters, priority symptoms and relationships between symptoms and has potential to support AYA's symptom self-management. Facilitating the self-management process, including self-efficacy, self-regulation behaviors, and patient-provider communication, is essential for improving symptom outcomes.

Studietyp

Observationell

Inskrivning (Faktisk)

30

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • Missouri
      • Kansas City, Missouri, Förenta staterna, 64108
        • The Childrens Mercy Hospital
    • Virginia
      • Richmond, Virginia, Förenta staterna, 23298
        • Virginia Commonwealth University/Massey Cancer Center

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

15 år till 29 år (Barn, Vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

pediatric and adult oncology clinics at the Virginia Commonwealth University Health System (VCUHS). Patients and parents of minor patients will be approached as inpatients or as outpatients at Massey Cancer Center Fellows Clinic and at the Pediatric Oncology Clinic.

Beskrivning

Inclusion Criteria:

  • 15 to 29 years of age with a diagnosis of cancer (primary, relapsed/recurrent, refractory, progressive, or secondary malignancy) receiving myelosuppressive chemotherapy.
  • Completion of at least one cycle of therapy for cancer and anticipated to have at least two additional cycles of myelosuppressive chemotherapy as part of the treatment plan.
  • Ability to speak and understand English as required to complete the C-SCAT and study measures.
  • Ability to use a tablet computer.

Exclusion Criteria:

  • Cognitive and/or physical inabilities to complete the proposed study measures as determined by self--report, parent report of minor, or medical chart.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
Intervention / Behandling
C-SCAT
C-SCAT arm: Completes and uses Computerized Symptom Capture Tool (C-SCAT) during visit with provider for two clinic visits.
Enhet: Computer Symptom Capture Tool
C-SCAT is an investigator developed app that is delivered via an iPad. The original CSCAT included the 30 symptoms from the Memorial Symptom Assessment Scale. The recently updated version includes two additional symptoms "feeling bloated" and "sexual dysfunction" that are included in the adult version of the MSAS.21 These symptoms were added based on feedback from the initial AYA sample of 13-29 year olds and in consideration of the developmental perspectives of the AYA population.The CSCAT allows the user to create an image of his or her symptom experience.
Andra namn:
  • C-SCAT

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in self-efficacy of symptom management measured by PROMIS Self-efficacy of symptom management scale.
Tidsram: Baseline, immediately after first provider visit (approx. 2 -4 weeks from baseline) and then immediately after second provider visit (approx. 6-8 weeks from baseline)
Baseline, immediately after first provider visit (approx. 2 -4 weeks from baseline) and then immediately after second provider visit (approx. 6-8 weeks from baseline)
Change in patient-provider communication from patient perspective measured by Patient-Provider Communication Scale.
Tidsram: Baseline, immediately after first provider visit (approx. 2 -4 weeks from baseline) and then immediately after second provider visit (approx. 6-8 weeks from baseline)
Baseline, immediately after first provider visit (approx. 2 -4 weeks from baseline) and then immediately after second provider visit (approx. 6-8 weeks from baseline)
Change in self-regulation of symptoms assessed by an audio-taped semi-structured interview.
Tidsram: Within 24 hours after first provider visit (approx. 2 -4 weeks from baseline) and Within 24 hours after second provider visit (approx. 6-8 weeks from baseline)
Semi-structured interviews to address how using the C-SCAT impacts self-regulation behaviors, such as self-monitoring, reflective thinking, and decision-making
Within 24 hours after first provider visit (approx. 2 -4 weeks from baseline) and Within 24 hours after second provider visit (approx. 6-8 weeks from baseline)
Change in provider's usefulness of using C-SCAT assessed by Provider Questionnaire.
Tidsram: After first provider visit (approx. 2 -4 weeks from baseline) and after second provider visit (approx. 6-8 weeks from baseline)
After first provider visit (approx. 2 -4 weeks from baseline) and after second provider visit (approx. 6-8 weeks from baseline)
Change in provider's usefulness of using C-SCAT assessed by providers' documentation of symptoms in the electronic health record.
Tidsram: After first provider visit (approx. 2 -4 weeks from baseline) and after second provider visit (approx. 6-8 weeks from baseline)
After first provider visit (approx. 2 -4 weeks from baseline) and after second provider visit (approx. 6-8 weeks from baseline)

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Virginia Commonwealth University

Samarbetspartners

National Cancer Institute (NCI)
St. Baldrick's Foundation

Utredare

  • Huvudutredare: Suzanne W. Ameringer, Ph.D., Virginia Commonwealth University

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 (Faktisk)

1 november 2016

Primärt slutförande (Faktisk)

25 oktober 2017

Avslutad studie (Faktisk)

25 oktober 2017

Studieregistreringsdatum

Först inskickad

6 november 2016

Först inskickad som uppfyllde QC-kriterierna

22 november 2016

Första postat (Uppskatta)

28 november 2016

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

22 december 2017

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

20 december 2017

Senast verifierad

1 december 2017

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • MCC-16-12876
  • HM20007402 (Annan identifierare: IRB)

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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 .

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