Advanced SarcomaSARC-DigitalNCT07642375
Study of the Impact of Digital Health Interventions on Symptom & Side-Effect Management in Metastatic Sarcoma Patients
A study testing Digital support in people with Advanced Sarcoma and Metastatic Sarcoma, run by CareAcross at 11 sites in Greece.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Sarcoma, Metastatic Sarcoma
- What is being tested?
- Digital support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 11 sitesGreece
- Study dates
- 22 Aug 2023to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
11 sites in 1 country
Greece11 sites, 11 recruiting
- Recruiting
401 General Military Hospital
Athens, 11525
Investigator, +302107494009, mededu401@gmail.com
- Recruiting
251 Air Force General Hospital
Athens, 11527
Investigator, +302107463399, vivliothiki@251gna.gr
- Recruiting
Attikon Hospital, 2nd clinic
Athens, 12461
Investigator, +302105831000, politis@attikonhospital.gov.gr
- Recruiting
Attikon Hospital, 4th clinic
Athens, 12461
Investigator, +302105831000, politis@attikonhospital.gov.gr
- Recruiting
Hygeia hospital
Athens, 15123
Investigator, +302106867000, info@hygeia.gr
- Recruiting
Mitera hospital
Athens, 15123
Investigator, +302106869000, info@hygeia.gr
- Recruiting
Metropolitan General Hospital
Athens, 15562
Investigator, +302106502000, info@metropolitan-general.gr
- Recruiting
Ippokrateio General Hospital
Athens, Greece
Investigator, +302132088000, academic@hippocratio.gr
- Recruiting
Bioclinic
Thessaloniki, 54622
Investigator, +302310372600, the.bioclinic@bioclinic.gr
- Recruiting
Ippokratio General Hospital of Thessaloniki
Thessaloniki, 54642
Investigator, +302313312000, manager@ippokratio.gr
- Recruiting
Papageorgiou General Hospital
Thessaloniki, 56403
Investigator, +302313323000, kep@papageorgiou-hospital.gr
About this study
Official title: 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.
- Conditions
- Advanced Sarcoma, Metastatic Sarcoma
- Being tested
- Digital support
- Keywords
- digital oncology, quality of life, qol, patient reported outcomes, PRO, supportive care, digital therapeutics
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital supportBehavioural
Personalized educational and supportive material, based on each patients' adverse events reported as PROs, delivered via the online platform.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | 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 | 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. Receives: Behavioral: Digital support |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment, until study completion, average 1 year
Secondary outcomes (2)
Overall Survival
Overall survival: Time to death, measured from time of enrollment
Measured: 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.
Measured: At study completion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2026
- Study start22 Aug 2023
- Primary completionAug 2026 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced SarcomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CareAcross
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hellenic Group of Sarcomas & Rare Cancers (HGSRC)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07642375
- Sponsor's protocol ID
- SARC-Digital
- Acronym
- SARC-Digital
- Status last verified
- Mar 2026
- First submitted
- 21 Apr 2026
- Last updated
- 11 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational, Randomized, Prospective Study of the Impact of Digital Health Interventions on Symptom and Side-Effect Management in Patients With Metastatic Sarcoma
- ClinicalTrials.gov ID
- NCT07642375
- Acronym / sponsor ID
- SARC-Digital / SARC-Digital
- Conditions
- Advanced Sarcoma, Metastatic Sarcoma
- Keywords
- digital oncology, quality of life, qol, patient reported outcomes, PRO, supportive care, digital therapeutics
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- CareAcrossIndustry (pharma, biotech, devices)
- Collaborators
- Hellenic Group of Sarcomas & Rare Cancers (HGSRC)
- Study start
- 22 Aug 2023 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 11 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –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 | Behavioral: Digital supportParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital supportPersonalized educational and supportive material, based on each patients' adverse events reported as PROs, delivered via the online platform. | Behavioural | Intervention |
Primary outcome
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.
2 secondary outcomes
Overall Survival
Time frame: At study completion
Patient satisfaction
Time frame: At study completion.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital support in people with Advanced Sarcoma and Metastatic Sarcoma, run by CareAcross at 11 sites in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Side effect improvement (time frame: From enrollment, until study completion, average 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.