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MyPatientPal: An App to Help Patients Manage Their Cancer Care

1. mars 2021 oppdatert av: Felicity Harper
MyPatientPal was developed in collaboration with both patient and oncologist stakeholders, is designed to facilitate such patient self-management through the daily reporting of side effects and medications.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

MyPatientPal is a patient app that is designed to help patients track and manage treatment side effects and medication adherence on a daily basis. Side effects (e.g., pain, fatigue, diarrhea, nausea) can be physically and emotionally debilitating, and when uncontrolled, can cause treatment complications, resulting in unscheduled care costs, patient out-of-pocket costs, and delays or discontinuation of treatment. The app allows personalization of daily entries such that patients can select the specific medications and dosage and side effects (using items from the NCI Common Terminology Criteria for Adverse Events) that they and/or their providers want to track. A charting feature provides an easy-to-read display of patients' daily reports, summarizing the intensity and frequency of side effects and medication use either by week or by month. These reports can also be printed out and shared with providers.

Studietype

Intervensjonell

Registrering (Faktiske)

40

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Michigan
      • Detroit, Michigan, Forente stater, 48201
        • Barbara Ann Karmanos Cancer Institute

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 til 75 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Have a diagnosis of any solid tumor cancer
  • Be starting treatment using an oral cancer therapeutic agent
  • Be able to speak, read, and write English
  • Willing and able to use their smartphone to use MyPatientPal

Exclusion Criteria:

  • Patients with cognitive or perceptual disturbances

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Annen
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Annen: Single-Arm Smartphone App Use
All patients in this single-arm study will use a smartphone-based app, MyPatientPal, to enter symptoms and track medications related to their cancer treatment. No drugs will be administered for the purposes of this behavioral study.
Annen: MyPatientPal smartphone app
All patients in this single-arm study will use a smartphone-based app, MyPatientPal, to enter symptoms and track medications related to their cancer treatment. No drugs will be administered for the purposes of this behavioral study.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Treatment-related symptoms
Tidsramme: Symptoms will be reported weekly via the internet for weeks 1-4 and daily for weeks 5-8 via the smartphone app
The frequency of treatment-related symptoms will be examined as the primary outcome. Patients will report the frequency and severity of symptoms selected from a symptom survey that consists of a list of 17 symptoms derived from the National Cancer Institute (NCI) CTCAE (Common Terminology Criteria for Adverse Events). Examples include diarrhea, constipation, vomiting, fever, and fatigue. Patients will be asked to mark the frequency of each symptom using a 5-point rating scale (from 0=none to 4=very severe). A total symptom impact score will be calculated by summing item responses across all symptoms. The investigators will compare the overall mean difference between the weekly and daily reporting phases.
Symptoms will be reported weekly via the internet for weeks 1-4 and daily for weeks 5-8 via the smartphone app

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Adherence to medications
Tidsramme: Adherence will be reported weekly via the internet for weeks 1-4 and daily for weeks 5-8 via the smartphone app
Patient adherence to oral chemotherapy will be examined as a secondary outcome. Patients will report any medications they are taking related to their treatment. Each report will consist of them answering a forced-choice question about whether each of their self-selected medications was taken (0=yes, 1=no). The investigators will compare the ratio of total days of adherence/total number of days per medication between the weekly and daily reporting phases. There will be no set number of medications that will be assessed given that patients will self-select their own medications, but on average, patients will report on 3 medications. Examples may include Xeloda, Ibrance, Femara, Tamoxifen, Remeron, Reglan, or Compazine.
Adherence will be reported weekly via the internet for weeks 1-4 and daily for weeks 5-8 via the smartphone app
Patient self-efficacy
Tidsramme: Patient self-efficacy will be reported weekly via the internet for weeks 1-4 and daily for weeks 5-8 via the smartphone app
Patient self-efficacy will be examined as a secondary outcome. Patient self-efficacy for managing treatment side effects will be assessed with a 13-item version of the Chronic Pain Self-Efficacy Scale, which has been modified for a cancer population. Items assess patients' self-efficacy for managing and coping with side effects. Examples are "How certain is the participant that they can control their fatigue?" and "How certain is the participant that they can cope with mild to moderate pain?" Items are rated on a 10-point Likert scale ranging from 10 = very uncertain and 100 = very certain and items scores are summed for a total score.
Patient self-efficacy will be reported weekly via the internet for weeks 1-4 and daily for weeks 5-8 via the smartphone app

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Felicity Harper

Etterforskere

  • Hovedetterforsker: Felicity Harper, PhD, Associate Professor/PI

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 (Faktiske)

1. oktober 2018

Primær fullføring (Faktiske)

8. oktober 2019

Studiet fullført (Faktiske)

11. oktober 2019

Datoer for studieregistrering

Først innsendt

22. september 2018

Først innsendt som oppfylte QC-kriteriene

22. september 2018

Først lagt ut (Faktiske)

25. september 2018

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

2. mars 2021

Siste oppdatering sendt inn som oppfylte QC-kriteriene

1. mars 2021

Sist bekreftet

1. mars 2021

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • 2018-063

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

Nei

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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. .

Kliniske studier på MyPatientPal smartphone app

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Sponsorer og samarbeidspartnere

Medisinsk tilstand

Legemiddelintervensjoner

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Forhold

Sjeldne sykdommer

Legemiddelintervensjoner

Kosttilskudd

Sponsor / samarbeidspartnere

Steder

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