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
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
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Athens, Grekland, 15562
- Rekrytering
- Metropolitan General Hospital
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Kontakt:
- Investigator
- Telefonnummer: +302106502000
- E-post: info@metropolitan-general.gr
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Athens, Grekland, 15123
- Rekrytering
- Mitera Hospital
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Kontakt:
- Investigator
- Telefonnummer: +302106869000
- E-post: info@hygeia.gr
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Athens, Grekland, 15123
- Rekrytering
- Hygeia Hospital
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Kontakt:
- Investigator
- Telefonnummer: +302106867000
- E-post: info@hygeia.gr
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Athens, Grekland, 11525
- Rekrytering
- 401 General Military Hospital
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Kontakt:
- Investigator
- Telefonnummer: +302107494009
- E-post: mededu401@gmail.com
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Athens, Grekland, 11527
- Rekrytering
- 251 Air Force General Hospital
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Kontakt:
- Investigator
- Telefonnummer: +302107463399
- E-post: vivliothiki@251gna.gr
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Athens, Grekland, 12461
- Rekrytering
- Attikon Hospital, 2nd clinic
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Kontakt:
- Investigator
- Telefonnummer: +302105831000
- E-post: politis@attikonhospital.gov.gr
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Athens, Grekland, 12461
- Rekrytering
- Attikon Hospital, 4th clinic
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Kontakt:
- Investigator
- Telefonnummer: +302105831000
- E-post: politis@attikonhospital.gov.gr
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Athens, Grekland, Greece
- Rekrytering
- Ippokrateio General Hospital
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Kontakt:
- Investigator
- Telefonnummer: +302132088000
- E-post: academic@hippocratio.gr
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Thessaloniki, Grekland, 54642
- Rekrytering
- Ippokratio General Hospital of Thessaloniki
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Kontakt:
- Investigator
- Telefonnummer: +302313312000
- E-post: manager@ippokratio.gr
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Thessaloniki, Grekland, 56403
- Rekrytering
- Papageorgiou General Hospital
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Kontakt:
- Investigator
- Telefonnummer: +302313323000
- E-post: kep@papageorgiou-hospital.gr
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Thessaloniki, Grekland, 54622
- Rekrytering
- Bioclinic
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Kontakt:
- Investigator
- Telefonnummer: +302310372600
- E-post: the.bioclinic@bioclinic.gr
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Inget ingripande: 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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Experimentell: 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Side effect improvement
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Overall Survival
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
Sponsor
Samarbetspartners
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- SARC-Digital
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