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Eine Selbstüberwachungsplattform zur Verfolgung der Arzneimittelsicherheit und -bedenken bei Krebspatienten

5. November 2026 aktualisiert von: University of Michigan Rogel Cancer Center

Patientenbeteiligung bei der Nutzung der Technologie zur Selbstverfolgung von Arzneimittelsicherheitsereignissen

This clinical trial evaluates the usefulness of a self-monitoring platform for tracking medication safety events and concerns in patients with lung, colorectal, breast, and prostate cancer. Patients receiving oral anticancer agents often encounter challenges in managing complex treatment regimens, potentially life-threatening toxicities, and drug-drug and drug-food interactions at home. To achieve the goal of medication safety, they need to become "vigilant partners" in medication and toxicity self-monitoring, including timely reporting of medication events to clinicians when their care transitions back home. In this study, patients use an online self-monitoring platform to track their experiences or concerns about taking their medications, including their experiences with symptoms. This platform may be a useful way for patients to track problems they have when taking their medications at home and may help them take better care of their health.

Studienübersicht

Status

Aktiv, nicht rekrutierend

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

71

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Vereinigte Staaten
    • Michigan
      • Ann Arbor, Michigan, Vereinigte Staaten, 48109
        • University of Michigan Comprehensive Cancer Center

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria:

  • Participants are adult patients (aged 18 years or older)
  • Diagnosed with lung, colorectal, breast, or prostate cancer
  • Are currently receiving active cancer treatments
  • Are self-managing one or more prescribed cancer medications
  • Participants must have access to technology devices (smartphone, tablet, computer) to track their experiences or concerns about medication safety events, or their family members can help them access technology devices to track the events or concerns
  • Speaks and reads English or has a support person (family member or friend) who can assist

Exclusion Criteria:

  • Can't access technology or do not use technology
  • Do not have access to the internet
  • Do not speak or read English
  • Not permitted to participate by their health care providers

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Versorgungsforschung
  • Zuteilung: N / A
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Health services research (self-monitoring platform)

Patients use the self-monitoring platform to track medication-related safety events and issues at home for 6 months. Patients may receive relevant educational materials and resources via the platform or by email and/or receive follow-up contact from a nurse practitioner as needed over the 6 months. Patients are encouraged to continue using the platform for an additional 6 months after the study period, as desired.
Sonstiges: Survey Administration

Ancillary studies

Sonstiges: Electronic Health Record Review

Ancillary studies

Sonstiges: Interview

Ancillary studies

Sonstiges: Educational Intervention

Receive educational materials and resources

Andere Namen:
  • Erziehung zum Eingreifen
  • Intervention durch Bildung
  • Intervention, pädagogisch
Verfahren: Follow-Up

Receive follow-up contact

Andere Namen:
  • Aktive Nachverfolgung
  • Nachsorge bei klinischen Anzeichen
  • CLSFUP
  • Nachverfolgen
  • nachverfolgen
  • Gefolgt
Sonstiges: Internet-Based Intervention

Use self-monitoring platform

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Self-reported system usability
Zeitfenster: Up to 6 months

Self-reported system usability will be assessed using the 10-item System Usability Scale. Will use descriptive statistics, such as mean and standard deviation for continuous variables, and frequency and percentage for categorical variables.
Up to 6 months
Perceived usefulness
Zeitfenster: Up to 6 months

Qualitative data, including brief interview data will be analyzed and summarized through content analysis.
Up to 6 months
Ease of use
Zeitfenster: Up to 6 months

Qualitative data, including brief interview data will be analyzed and summarized through content analysis.
Up to 6 months
Attitudes toward use
Zeitfenster: Up to 6 months

Qualitative data, including brief interview data will be analyzed and summarized through content analysis.
Up to 6 months
Intention to use and continuous use of the system over time
Zeitfenster: Up to 12 months

Qualitative data, including brief interview data will be analyzed and summarized through content analysis.
Up to 12 months
Self-reported patient engagement
Zeitfenster: Up to 6 months

Self-reported patient engagement will be measured by the 9-item Twente Engagement with Ehealth Technologies Scale (TWEETS), including three dimensions, behavioral engagement, cognitive engagement, and affective engagement. Will use the overall TWEETS score to evaluate patient engagement in this study, rather than analyzing each dimension separately. Will use descriptive statistics, such as mean and standard deviation for continuous variables, and frequency and percentage for categorical variables. Will use repeated measures analysis of variance to assess the changes in mean scores of patient engagement. Univariate associations between baseline personal and clinical factors and patient engagement at each time point will be assessed using correlation analyses (Pearson or Spearman), Chi-square tests, or non-parametric Mann-Whitney U tests, depending on the variable types. Multiple linear regressions will be conducted to assess associations between patient engagement and outcomes.
Up to 6 months
System usage over time
Zeitfenster: Up to 12 months

Will be objectively recorded by the system logs and analyzed using Google Analytics (dashboard only), including parameters like the number of logins, number of tab pages clicked, number of events or concerns self-tracked, and more. Will use descriptive statistics, such as mean and standard deviation for continuous variables, and frequency and percentage for categorical variables.
Up to 12 months
Patient activation levels
Zeitfenster: Up to 6 months

Patient activation levels will be measured by the Short Form of Patient Activation Measure. Will use descriptive statistics, such as mean and standard deviation for continuous variables, and frequency and percentage for categorical variables.
Up to 6 months
Medication self-management ability
Zeitfenster: Up to 6 months

Medication self-management ability will be measured by the Measure of Medication Self-Management. Will use descriptive statistics, such as mean and standard deviation for continuous variables, and frequency and percentage for categorical variables.
Up to 6 months
Symptom distress
Zeitfenster: Up to 6 months

Symptom distress will be measured by the 19-item MD Anderson Symptom Inventory. Will use descriptive statistics, such as mean and standard deviation for continuous variables, and frequency and percentage for categorical variables.
Up to 6 months
Health related quality of life
Zeitfenster: Up to 6 months

Health-related quality of life will be measured by the 27-item Functional Assessment of Cancer Therapy - General. Will use descriptive statistics, such as mean and standard deviation for continuous variables, and frequency and percentage for categorical variables.
Up to 6 months
Number of emergency room visits
Zeitfenster: Up to 12 months

Will be measured by both self-report and chart review. Will use descriptive statistics, such as mean and standard deviation for continuous variables, and frequency and percentage for categorical variables.
Up to 12 months
Number of hospitalizations
Zeitfenster: Up to 12 months

Will be measured by both self-report and chart review. Will use descriptive statistics, such as mean and standard deviation for continuous variables, and frequency and percentage for categorical variables.
Up to 12 months
User experiences with the system
Zeitfenster: Up to 6 months

Participants' user experiences with the system, such as perceived facilitators or barrios to system use, along with their suggestions for system improvement, will be collected through a brief individual interview. Qualitative data, including brief interview data will be analyzed and summarized through content analysis.
Up to 6 months

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Self-tracked, structured medication safety events or concerns
Zeitfenster: Up to 12 months

To understand the nature and causes of events and concerns, self-tracked, structured medication safety events or concerns tracking data from the system, such as the number and types of events or concerns self-tracked, will be summarized using descriptive statistics. The free-text tracking data from the system will be analyzed and summarized through content analysis or natural language processing techniques, depending on data volume.
Up to 12 months

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

University of Michigan Rogel Cancer Center

Mitarbeiter

Agency for Healthcare Research and Quality (AHRQ)

Ermittler

  • Hauptermittler: Yun Jiang, University of Michigan Rogel Cancer Center
  • Hauptermittler: Yang Gong, UTHealth Houston McWilliam School of Biomedical Informatics

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

9. Januar 2026

Primärer Abschluss (Geschätzt)

1. März 2027

Studienabschluss (Geschätzt)

1. März 2027

Studienanmeldedaten

Zuerst eingereicht

4. Dezember 2025

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

4. Dezember 2025

Zuerst gepostet (Tatsächlich)

18. Dezember 2025

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

9. November 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

5. November 2026

Zuletzt verifiziert

1. November 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • UMCC 2025.050
  • NCI-2025-08754 (Registrierungskennung: CTRP (Clinical Trial Reporting Program))
  • HUM00272763 (Andere Kennung: University of Michigan)
  • R01HS027846 (US-AHRQ-Zuschuss/Vertrag)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Produkt, das in den USA hergestellt und aus den USA exportiert wird

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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