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

CareAcross108 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

108

Conditions

Advanced Sarcoma Metastatic Sarcoma

Interventions

Digital supportBEHAVIORAL

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (11)

401 General Military Hospital

Athens, Greece

RECRUITING

251 Air Force General Hospital

Athens, Greece

RECRUITING

Outcomes

Primary Outcomes

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

Overall Survival

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

Time frame: 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.

Time frame: At study completion.

Data from ClinicalTrials.gov

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