En selvmonitoringsplatform til overvågning af lægemiddelsikkerhed og bekymringer hos kræftpatienter
Patientinddragelse i brug af teknologien til selvregistrering af medicinsikkerhedshændelser
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.
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Michigan
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Ann Arbor, Michigan, Forenede Stater, 48109
- University of Michigan Comprehensive Cancer Center
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-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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. |
Ancillary studies Ancillary studies Ancillary studies Receive educational materials and resources
Andre navne:
Receive follow-up contact
Andre navne:
Use self-monitoring platform |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Self-reported system usability
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Self-tracked, structured medication safety events or concerns
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Yun Jiang, University of Michigan Rogel Cancer Center
- Ledende efterforsker: Yang Gong, UTHealth Houston McWilliam School of Biomedical Informatics
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Urogenitale sygdomme
- Genitale sygdomme
- Genitale neoplasmer, mandlige
- Urogenitale neoplasmer
- Neoplasmer efter sted
- Neoplasmer
- Kønssygdomme, mandlige
- Prostatasygdomme
- Mandlige urogenitale sygdomme
- Tarmsygdomme
- Luftvejssygdomme
- Gastrointestinale neoplasmer
- Neoplasmer i fordøjelsessystemet
- Sygdomme i fordøjelsessystemet
- Gastrointestinale sygdomme
- Intestinale neoplasmer
- Endetarmssygdomme
- Lungesygdomme
- Neoplasmer i luftvejene
- Thoracale neoplasmer
- Tyktarmssygdomme
- Hudsygdomme
- Brystsygdomme
- Hud- og bindevævssygdomme
- Prostatiske neoplasmer
- Lungeneoplasmer
- Kolorektale neoplasmer
- Brystneoplasmer
- Sundhedsvæsenets kvalitet, adgang og evaluering
- Undersøgelsesteknikker
- Epidemiologiske metoder
- Dataindsamling
- Evalueringsmekanismer til sundhedsvæsenet
- Sundhedskvalitet
- Folkesundhed
- Miljø og folkesundhed
- Sundhedstjenester
- Sundhedsfaciliteter Arbejdsstyrke og tjenester
- Børns sundhedsydelser
- Fællesskabets sundhedsydelser
- Forebyggende sundhedsydelser
- Socioøkonomiske faktorer
- Befolkningsegenskaber
- Immunologiske teknikker
- Genetiske teknikker
- Epidemiologiske undersøgelser
- Epidemiologiske undersøgelsesegenskaber
- Kromatinimmunudfældning
- Nukleotid-sekventering med høj kapacitet
- Sekvensanalyse
- Sekvensanalyse, DNA
- Immunudfældning
- Kohortundersøgelser
- Metoder
- Interviews som emne
- Tidlig indgriben, uddannelsesmæssig
- Uddannelsesstatus
- Kromatinimmunudfældningssekvensering
- Opfølgningsundersøgelser
Andre undersøgelses-id-numre
- UMCC 2025.050
- NCI-2025-08754 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- HUM00272763 (Anden identifikator: University of Michigan)
- R01HS027846 (U.S.A. AHRQ bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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