SarcomaSARQUALITYNCT06805669
This is a Randomized Study of Early Involvement of Palliative Care Along Side Standard Treatment Versus Standard Treatment Alone in Newly Diagnosed Patients With Advanced or Metastatic Soft Tissue Sarcoma (SARQUALITY)
A study testing Early referral to palliative care and Standard Treatment in people with Sarcoma, run by Mount Sinai Hospital, Canada at 1 site in Canada.
Trial summary
The goal of this study is to learn whether early referral to palliative care improves quality of life for patients with advanced sarcoma. Participants enrolled in this study will complete quality of life questionnaires before starting their treatment, and every 6 weeks for 24 weeks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcoma
- What is being tested?
- Early referral to palliative care and Standard Treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteCanada
- Study dates
- 20 Mar 2024to Oct 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
- Signed written and voluntary informed consent.
- Have histologically documented advanced sarcoma, either locally advanced not amenable to curative treatment, or metastatic.
- Age ≥ 18 years.
- Have not received any previous systemic treatment with palliative intent for advanced sarcoma.
- Performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) performance scale.
- Life expectancy > 6 months.
- Willing/able to complete questionnaires.
Who cannot join
- Clinical evidence of cognitive impairment that would preclude the ability to provide informed consent and complete questionnaires, at investigator´s discretion.
- Patient in need of urgent home support services or symptom management through a palliative care team.
- Patient is being actively followed by a palliative care physician.
- Active psychiatric disorder or drug abuse.
- Insufficient English literacy to complete questionnaires.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Mount Sinai Hospital
Toronto, Ontario, M5G 1X5
Clinical Trials Manager, 4165868440, Oncology.Research@sinaihealth.ca
Albiruni R. Abdul Razak
About this study
Official title: Integrating Early Palliative Care in Advanced SARcoma Patients for Enhanced QUALITY of Life: the SARQUALITY Study
The goal of this study is to learn whether early referral to palliative care improves quality of life for patients with advanced sarcoma.
Participants enrolled in this study will complete quality of life questionnaires before starting their treatment, and every 6 weeks for 24 weeks.
- Conditions
- Sarcoma
- Being tested
- Early referral to palliative care, Standard Treatment
- Keywords
- Sarcoma, Palliative Care
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early referral to palliative careOther
Participant will be referred to palliative care at start of systemic treatment
Standard TreatmentOther
Participants will be referred to palliative care upon appearance of uncontrollable symptoms.
| Study group | Role | What they receive |
|---|---|---|
| Early Referral to Palliative Care | Experimental | Not described Receives: Other: Early referral to palliative care |
| Standard Treatment | Other | Not described Receives: Other: Standard Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the difference of Health Related Quality of Life (HRQoL) for sarcoma patients who receive early palliative care versus not
HRQoL will be assessed using ESAS-r (Edmonton Symptom Assessment System - revised) and EORTC QLQ-C30 (European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire C-30).
Measured: From enrollment/baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2025
- Study start20 Mar 2024
- Primary completionApr 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- None (open label)
- Enrolment
- 136 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mount Sinai Hospital, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Albiruni R. Abdul Razak, Principal investigator, MOUNT SINAI HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06805669
- Sponsor's protocol ID
- SARC-004
- Acronym
- SARQUALITY
- Status last verified
- Jan 2025
- First submitted
- 23 Jan 2025
- Last updated
- 3 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Only IPD used in the results publication will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrating Early Palliative Care in Advanced SARcoma Patients for Enhanced QUALITY of Life: the SARQUALITY Study
- ClinicalTrials.gov ID
- NCT06805669
- Acronym / sponsor ID
- SARQUALITY / SARC-004
- Conditions
- Sarcoma
- Keywords
- Sarcoma, Palliative Care
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- Mount Sinai Hospital, CanadaUniversity, hospital or other
- Study start
- 20 Mar 2024 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 3 Feb 2025 (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 goal of this study is to learn whether early referral to palliative care improves quality of life for patients with advanced sarcoma.
Participants enrolled in this study will complete quality of life questionnaires before starting their treatment, and every 6 weeks for 24 weeks.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Referral to Palliative Care | Experimental | Other: Early referral to palliative care |
| Standard Treatment | Other | Other: Standard Treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Signed written and voluntary informed consent.
- Have histologically documented advanced sarcoma, either locally advanced not amenable to curative treatment, or metastatic.
- Age ≥ 18 years.
- Have not received any previous systemic treatment with palliative intent for advanced sarcoma.
- Performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) performance scale.
Key exclusion criteria (5 listed)
- Clinical evidence of cognitive impairment that would preclude the ability to provide informed consent and complete questionnaires, at investigator´s discretion.
- Patient in need of urgent home support services or symptom management through a palliative care team.
- Patient is being actively followed by a palliative care physician.
- Active psychiatric disorder or drug abuse.
- Insufficient English literacy to complete questionnaires.
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 |
|---|---|---|
| Early referral to palliative careParticipant will be referred to palliative care at start of systemic treatment | Other | Early Referral to Palliative Care |
| Standard TreatmentParticipants will be referred to palliative care upon appearance of uncontrollable symptoms. | Other | Standard Treatment |
Primary outcome
To determine the difference of Health Related Quality of Life (HRQoL) for sarcoma patients who receive early palliative care versus not
Time frame: From enrollment/baseline to 12 weeks
HRQoL will be assessed using ESAS-r (Edmonton Symptom Assessment System - revised) and EORTC QLQ-C30 (European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire C-30).
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 3 Feb 2025.
- Individual participant dataSharing planned: Yes. Only IPD used in the results publication will be shared.
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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.
Albiruni R. Abdul Razak principal investigator
MOUNT SINAI HOSPITAL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early referral to palliative care and Standard Treatment in people with Sarcoma, run by Mount Sinai Hospital, Canada at 1 site in Canada.
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 7 inclusion and 5 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 3 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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?
Contact Clinical Trials Manager (416-586-8440, Oncology.Research@sinaihealth.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the difference of Health Related Quality of Life (HRQoL) for sarcoma patients who receive early palliative care versus not (time frame: From enrollment/baseline to 12 weeks). 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 3 Feb 2025.