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Comparing Early referral to palliative care with Standard Treatment for sarcoma

Official title: 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)

Integrating Early Palliative Care in Advanced SARcoma Patients for Enhanced QUALITY of Life: the SARQUALITY Study

Condition: SarcomaSponsor: Mount Sinai Hospital, CanadaTarget enrollment: 136
  • 2 groups
  • One site, in Toronto
  • Recruiting
Mount Sinai Hospital, Toronto, Ontario

Interventions

  • Other intervention

    Early referral to palliative care

    Participant will be referred to palliative care at start of systemic treatment

  • Other intervention

    Standard Treatment

    Participants will be referred to palliative care upon appearance of uncontrollable symptoms.

Canadian Sites (1)

1 of 1 recruiting

  • Mount Sinai Hospital

    Toronto, Ontario

    Recruiting

Eligibility Criteria

See who this study is looking for12 criteria

The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.

Inclusion

  • +Age ≥ 18 years.
  • +Performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) performance scale.
  • +Signed written and voluntary informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →.
  • +Have histologically documented advanced sarcoma, either locally advanced not amenable to curative treatment, or metastatic.
  • +Have not received any previous systemic treatment with palliative intent for advanced sarcoma.
  • +Life expectancy \> 6 months.
  • +Willing/able to complete questionnaires.

Exclusion

  • Clinical evidence of cognitive impairment that would preclude the ability to provide informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → and complete questionnaires, at investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →´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.
5 concepts to explore on this page · up to 1,300 pointsTap any term to learn what it means.

In plain language

Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.

Learning 
What this study is

This study is testing a way to improve comfort and quality of life alongside other care.

This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.

From the trial registry

Built from these fields:

  • designModule.designInfo.primaryPurpose
  • designModule.phases
Who receives what

There are 2 groups in this study.

Group A receives Early referral to palliative care.

Registry label: A: Early Referral to Palliative Care

Group B receives Standard TreatmentStandard of careThe treatment normally given for a condition outside a study.Read more →.

Registry label: B: Standard Treatment

From the trial registry

Built from these fields:

  • armsInterventionsModule.armGroups[].label
  • armsInterventionsModule.armGroups[].type
  • armsInterventionsModule.armGroups[].interventionNames
How the study is run

Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.

This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.

From the trial registry

Built from these fields:

  • designModule.designInfo.allocation
  • designModule.designInfo.maskingInfo.masking
Is there a placebo?

This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.

From the trial registry

Built from these fields:

  • armsInterventionsModule.armGroups[].type
  • armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for

The study lists a minimum age of 18 years, with no upper limit given.

The study is open to people of any sex.

The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.

These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.

From the trial registry

Built from these fields:

  • eligibilityModule.minimumAge
  • eligibilityModule.sex
  • eligibilityModule.healthyVolunteers
How big and how long

The study aims to enrol about 136 people.

The study is currently expected to finish around October 2027.

The main measurement is taken over: From enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more →/baselineBaselineYour starting measurements, taken before treatment begins.Read more → to 12 weeks.

From the trial registry

Built from these fields:

  • designModule.enrollmentInfo.count
  • statusModule.completionDateStruct.date
  • outcomesModule.primaryOutcomes[].timeFrame
What the study measures

To determine the difference of Health Related Quality of Life (HRQoL) for sarcoma patients who receive early palliative care versus not — measured over From enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more →/baselineBaselineYour starting measurements, taken before treatment begins.Read more → to 12 weeks.

From the trial registry

Built from these fields:

  • outcomesModule.primaryOutcomes[].measure
  • outcomesModule.primaryOutcomes[].timeFrame

Source: NCT06805669 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.

Not medical advice. What do these terms mean?

What is being tested — in plain terms

About Early referral to palliative careOther

Participant will be referred to palliative care at start of systemic treatment

From the trial registry — its own words, unedited.

What a other is here: An intervention the registry did not place in another category.

Read the full explanation → · in clinical review

About Standard TreatmentOther

Participants will be referred to palliative care upon appearance of uncontrollable symptoms.

From the trial registry — its own words, unedited.

What a other is here: An intervention the registry did not place in another category.

Read the full explanation → · in clinical review

Common questions

Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.

Am I eligible for this trial?

Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.

What the study lists: a minimum age of 18 years.

The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.

The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.

From the trial registry
  • eligibilityModule.minimumAge
  • eligibilityModule.eligibilityCriteria
Is there a placebo?

This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.

From the trial registry
  • armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?

This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.

Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.

From the trial registry
  • designModule.designInfo.maskingInfo.masking
  • designModule.designInfo.allocation
Who can join?

The study lists a minimum age of 18 years, with no upper limit given.

It is open to people of any sex.

It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.

Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.

From the trial registry
  • eligibilityModule.minimumAge
  • eligibilityModule.sex
  • eligibilityModule.healthyVolunteers
How long would this take?

The study's main measurement is taken over: From enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more →/baselineBaselineYour starting measurements, taken before treatment begins.Read more → to 12 weeks.

The study as a whole is currently expected to finish around 2027-10.

How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.

From the trial registry
  • outcomesModule.primaryOutcomes[].timeFrame
  • statusModule.completionDateStruct.date
How many people are taking part?

The study aims to enrol about 136 people.

From the trial registry
  • designModule.enrollmentInfo.count
Where is this happening?

This study lists one location: Toronto, Ontario, Canada.

Sites can open and close during a study, so confirm with the team before travelling.

From the trial registry
  • trial_locations

About This Trial

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.

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This page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.