Advanced Sarcoma, Metastatic Sarcoma
Conditions
Keywords
digital oncology, quality of life, qol, patient reported outcomes, PRO, supportive care, digital therapeutics
Brief summary
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
BEHAVIORALDigital support
Personalized educational and supportive material, based on each patients' adverse events reported as PROs, delivered via the online platform.
Sponsors
CareAcross
Hellenic Group of Sarcomas & Rare Cancers (HGSRC)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Side effect improvement | From enrollment, until study completion, average 1 year | 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: * Fatigue * Dry skin * Rash * Constipation * Nausea * Lymphedema * Vomiting * Mucositis * Neuropathy * Sexual dysfunction 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | At study completion | Overall survival: Time to death, measured from time of enrollment |
| Patient satisfaction | At study completion. | 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. |
Countries
Greece
Outcome results
None listed