Study of the Impact of Digital Health Interventions on Symptom & Side-Effect Management in Metastatic Sarcoma Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Digital support.
- Who it may be relevant to
- Registry conditions: Advanced Sarcoma, Metastatic Sarcoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Greece
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Observational, Randomized, Prospective Study of the Impact of Digital Health Interventions on Symptom and Side-Effect Management in Patients With Metastatic Sarcoma
Overview
The objective of this prospective study is to capture the quality of life of patients with locally advanced or metastatic sarcoma, and investigate the effectiveness of support provided through a personalized web-based platform.
Interventions
- Behavioral Digital support
Personalized educational and supportive material, based on each patients' adverse events reported as PROs, delivered via the online platform.
Primary outcome measures
- Side effect improvement [Time frame: From enrollment, until study completion, average 1 year]
Secondary outcome measures (2)
- Overall Survival [Time frame: At study completion]
- Patient satisfaction [Time frame: At study completion.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Supportive care
Study locations
Greece · 11 centers
- 401 General Military Hospital — Athens
- 251 Air Force General Hospital — Athens
- Attikon Hospital, 2nd clinic — Athens
- Attikon Hospital, 4th clinic — Athens
- Hygeia hospital — Athens
- Mitera hospital — Athens
- Metropolitan General Hospital — Athens
- Ippokrateio General Hospital — Athens
- … and 3 more centers
Identifiers
NCT: NCT07642375 · SARC-Digital