Health TrialsbyHealthPanel

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

ConditionsAdvanced SarcomaMetastatic Sarcoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCareAcross

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Digital support

    Behavioral

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

Treatment groups

108 Participants
are divided into 2 treatment groups
Group A: ControlNo intervention 0 interventions
Group B: InterventionExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
From enrollment, until study completion, average 1 year

Secondary outcomes

1

Overall Survival

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

Time frame
At study completion
2

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.

Time frame
At study completion.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

CareAcross

Lead sponsor

Hellenic Group of Sarcomas & Rare Cancers (HGSRC)

Collaborator

Source ClinicalTrials.gov
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