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

CareAcross

Status: Enrolling

Conditions: Advanced Sarcoma; Metastatic Sarcoma

Treatments: Behavioral: Digital support

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT07642375

SARC-Digital

Details and patient eligibility

About

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.

Enrollment: 108 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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108 participants in 2 patient groups

Control

No Intervention group

Description:

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 group

Description:

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.

Treatment:

Behavioral: Digital support