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NCT Number: NCT07642375

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

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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Key information

Conditions

Advanced Sarcoma Metastatic Sarcoma Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Sarcoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

251 Air Force General Hospital, Athens, Greece

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Digital support

Behavioral

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Overall Survival

    Time frame: At study completion

    Overall survival: Time to death, measured from time of enrollment

  2. 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.

Sponsors and collaborators

Lead sponsor

CareAcross

Industry

Collaborators

  • Hellenic Group of Sarcomas & Rare Cancers (HGSRC)

Registry information

Official study title

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

Acronym: SARC-Digital

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Jun 11, 2026
Registry last updated
Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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