NCT07642375

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
8mo left

Started Aug 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

11 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress82%
Aug 2023Feb 2027

Study Start

First participant enrolled

August 22, 2023

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

April 21, 2026

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 11, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Last Updated

June 11, 2026

Status Verified

March 1, 2026

Enrollment Period

2.9 years

First QC Date

April 21, 2026

Last Update Submit

June 7, 2026

Conditions

Advanced SarcomaMetastatic Sarcoma

Keywords

digital oncologyquality of lifeqolpatient reported outcomesPROsupportive caredigital therapeutics

Outcome Measures

Primary Outcomes (1)

  • 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: * 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.

    From enrollment, until study completion, average 1 year

Secondary Outcomes (2)

  • Overall Survival

    At study completion

  • Patient satisfaction

    At study completion.

Study Arms (2)

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.

Behavioral: Digital support

Interventions

Digital supportBEHAVIORAL

Personalized educational and supportive material, based on each patients' adverse events reported as PROs, delivered via the online platform.

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

401 General Military Hospital

Athens, 11525, Greece

RECRUITING

251 Air Force General Hospital

Athens, 11527, Greece

RECRUITING

Attikon Hospital, 2nd clinic

Athens, 12461, Greece

RECRUITING

Attikon Hospital, 4th clinic

Athens, 12461, Greece

RECRUITING

Hygeia hospital

Athens, 15123, Greece

RECRUITING

Mitera hospital

Athens, 15123, Greece

RECRUITING

Metropolitan General Hospital

Athens, 15562, Greece

RECRUITING

Ippokrateio General Hospital

Athens, Greece, Greece

RECRUITING

Bioclinic

Thessaloniki, 54622, Greece

RECRUITING

Ippokratio General Hospital of Thessaloniki

Thessaloniki, 54642, Greece

RECRUITING

Papageorgiou General Hospital

Thessaloniki, 56403, Greece

RECRUITING

MeSH Terms

Conditions

Sarcoma

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2026

First Posted

June 11, 2026

Study Start

August 22, 2023

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

February 1, 2027

Last Updated

June 11, 2026

Record last verified: 2026-03

Locations

GR(11)