Study of the Impact of Digital Health Interventions on Symptom & Side-Effect Management in Metastatic Sarcoma Patients (SARC-Digital)
Observational, Randomized, Prospective Study of the Impact of Digital Health Interventions on Symptom and Side-Effect Management in Patients With Metastatic Sarcoma
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Athens, Hellas, 15562
- Rekruttering
- Metropolitan General Hospital
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Ta kontakt med:
- Investigator
- Telefonnummer: +302106502000
- E-post: info@metropolitan-general.gr
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Athens, Hellas, 15123
- Rekruttering
- Mitera Hospital
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Ta kontakt med:
- Investigator
- Telefonnummer: +302106869000
- E-post: info@hygeia.gr
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Athens, Hellas, 15123
- Rekruttering
- Hygeia Hospital
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Ta kontakt med:
- Investigator
- Telefonnummer: +302106867000
- E-post: info@hygeia.gr
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Athens, Hellas, 11525
- Rekruttering
- 401 General Military Hospital
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Ta kontakt med:
- Investigator
- Telefonnummer: +302107494009
- E-post: mededu401@gmail.com
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Athens, Hellas, 11527
- Rekruttering
- 251 Air Force General Hospital
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Ta kontakt med:
- Investigator
- Telefonnummer: +302107463399
- E-post: vivliothiki@251gna.gr
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Athens, Hellas, 12461
- Rekruttering
- Attikon Hospital, 2nd clinic
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Ta kontakt med:
- Investigator
- Telefonnummer: +302105831000
- E-post: politis@attikonhospital.gov.gr
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Athens, Hellas, 12461
- Rekruttering
- Attikon Hospital, 4th clinic
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Ta kontakt med:
- Investigator
- Telefonnummer: +302105831000
- E-post: politis@attikonhospital.gov.gr
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Athens, Hellas, Greece
- Rekruttering
- Ippokrateio General Hospital
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Ta kontakt med:
- Investigator
- Telefonnummer: +302132088000
- E-post: academic@hippocratio.gr
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Thessaloniki, Hellas, 54642
- Rekruttering
- Ippokratio General Hospital of Thessaloniki
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Ta kontakt med:
- Investigator
- Telefonnummer: +302313312000
- E-post: manager@ippokratio.gr
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Thessaloniki, Hellas, 56403
- Rekruttering
- Papageorgiou General Hospital
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Ta kontakt med:
- Investigator
- Telefonnummer: +302313323000
- E-post: kep@papageorgiou-hospital.gr
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Thessaloniki, Hellas, 54622
- Rekruttering
- Bioclinic
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Ta kontakt med:
- Investigator
- Telefonnummer: +302310372600
- E-post: the.bioclinic@bioclinic.gr
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
Inclusion Criteria:
- Age of ≥ 18 years.
- Diagnosis of locally advanced or metastatic sarcoma of any location and origin.
- Ability to understand and operate in a digital environment.
- Patients planned to start standard of care treatment within the next month, or are currently undergoing standard of care treatment of any line.
- Treatments include surgery, radiotherapy, chemotherapy, immunotherapy, targeted therapy, hormonal therapy, or any combination of the above.
Exclusion Criteria:
- Limited ability or willingness to report side-effects on an online platform.
- Performance status >3.
- Life expectancy of <6 months.
- Participation in an interventional clinical trial with investigational drugs or devices.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Ingen inngripen: Control
Participants in this group utilize the personalized digital platform to record adverse events as Patient-Reported Outcomes (PROs). They only receive an acknowledgement of their submission. Their standard clinical treatment and monitoring continue unaffected. |
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Eksperimentell: Intervention
Participants in this group utilize the personalized digital platform to record adverse events as Patient-Reported Outcomes (PROs). Additionally, they receive short textual personalized educational and supportive material online. Their standard clinical treatment and monitoring continue unaffected. |
Personalized educational and supportive material, based on each patients' adverse events reported as PROs, delivered via the online platform.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Side effect improvement
Tidsramme: From enrollment, until study completion, average 1 year
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Patient-Reported Outcomes (PROs) consisting of treatment related side-effects that patients themselves report on the online platform. The reported side-effects will be evaluated throughout the entire duration of the study. 10 side-effects will be captured (each measured as either present or absent) throughout the study:
Only data from patients who report at least 2 times will be eligible for outcome analysis. The following calculation and evaluation will be conducted: For each of the two Arms, the percentage of patients who at the final side-effect data collection reported fewer than 70% of the specific side-effects they had reported at previous side-effect data collection timepoints. |
From enrollment, until study completion, average 1 year
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Overall Survival
Tidsramme: At study completion
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Overall survival: Time to death, measured from time of enrollment
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At study completion
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Patient satisfaction
Tidsramme: At study completion.
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Assess patient satisfaction with the digital platform.
This will be measured by a single question posed to each patient, that will capture their satisfaction with the platform, on a Likert scale of 0-10.
Higher scores indicate a better outcome.
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At study completion.
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Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- SARC-Digital
Legemiddel- og utstyrsinformasjon, studiedokumenter
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