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)

NCT ID: NCT06805669

Last Updated: 2025-02-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

136 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-20

Study Completion Date

2027-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Sarcoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Early Referral to Palliative Care

Group Type EXPERIMENTAL

Early referral to palliative care

Intervention Type OTHER

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

Standard Treatment

Group Type OTHER

Standard Treatment

Intervention Type OTHER

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

Interventions

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Early referral to palliative care

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

Intervention Type OTHER

Standard Treatment

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mount Sinai Hospital, Canada

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Albiruni R. Abdul Razak

Role: PRINCIPAL_INVESTIGATOR

MOUNT SINAI HOSPITAL

Locations

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Mount Sinai Hospital

Toronto, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Clinical Trials Manager

Role: CONTACT

416-586-8440

Facility Contacts

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Clinical Trials Manager

Role: primary

4165868440

Other Identifiers

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SARC-004

Identifier Type: -

Identifier Source: org_study_id

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