Study of the Impact of Digital Health Interventions on Symptom & Side-Effect Management in Metastatic Sarcoma Patients (SARC-Digital)

June 7, 2026 updated by: CareAcross

Observational, Randomized, Prospective Study of the Impact of Digital Health Interventions on Symptom and Side-Effect Management in Patients With Metastatic Sarcoma

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

108

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Athens, Greece, 15562
      • Athens, Greece, 15123
        • Recruiting
        • Mitera hospital
        • Contact:
      • Athens, Greece, 15123
        • Recruiting
        • Hygeia Hospital
        • Contact:
      • Athens, Greece, 11525
        • Recruiting
        • 401 General Military Hospital
        • Contact:
      • Athens, Greece, 11527
        • Recruiting
        • 251 Air Force General Hospital
        • Contact:
      • Athens, Greece, 12461
      • Athens, Greece, 12461
      • Athens, Greece, Greece
        • Recruiting
        • Ippokrateio General Hospital
        • Contact:
      • Thessaloniki, Greece, 54642
        • Recruiting
        • Ippokratio General Hospital of Thessaloniki
        • Contact:
      • Thessaloniki, Greece, 56403
      • Thessaloniki, Greece, 54622

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 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.
Experimental: 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.
Behavioral: Digital support
Personalized educational and supportive material, based on each patients' adverse events reported as PROs, delivered via the online platform.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Side effect improvement
Time Frame: 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.
From enrollment, until study completion, average 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: At study completion
Overall survival: Time to death, measured from time of enrollment
At study completion
Patient satisfaction
Time Frame: 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.
At study completion.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CareAcross

Collaborators

Hellenic Group of Sarcomas & Rare Cancers (HGSRC)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 22, 2023

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

February 1, 2027

Study Registration Dates

First Submitted

April 21, 2026

First Submitted That Met QC Criteria

June 7, 2026

First Posted (Actual)

June 11, 2026

Study Record Updates

Last Update Posted (Actual)

June 11, 2026

Last Update Submitted That Met QC Criteria

June 7, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SARC-Digital

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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