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| Name | Class |
|---|---|
| Hellenic Group of Sarcomas & Rare Cancers (HGSRC) | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | 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. | |
| Intervention | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Digital support | Behavioral | Personalized educational and supportive material, based on each patients' adverse events reported as PROs, delivered via the online platform. |
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| Measure | Description | Time Frame |
|---|---|---|
| Side effect improvement | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Overall survival: Time to death, measured from time of enrollment | At study completion |
| Patient satisfaction | 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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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 401 General Military Hospital | Recruiting | Athens | 11525 | Greece |
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| At study completion. |
| 251 Air Force General Hospital | Recruiting | Athens | 11527 | Greece |
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| Attikon Hospital, 2nd clinic | Recruiting | Athens | 12461 | Greece |
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| Attikon Hospital, 4th clinic | Recruiting | Athens | 12461 | Greece |
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| Hygeia hospital | Recruiting | Athens | 15123 | Greece |
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| Mitera hospital | Recruiting | Athens | 15123 | Greece |
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| Metropolitan General Hospital | Recruiting | Athens | 15562 | Greece |
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| Ippokrateio General Hospital | Recruiting | Athens | Greece | Greece |
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| Bioclinic | Recruiting | Thessaloniki | 54622 | Greece |
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| Ippokratio General Hospital of Thessaloniki | Recruiting | Thessaloniki | 54642 | Greece |
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| Papageorgiou General Hospital | Recruiting | Thessaloniki | 56403 | Greece |
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| ID | Term |
|---|---|
| D012509 | Sarcoma |
| ID | Term |
|---|---|
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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