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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)

Mount Sinai Hospital, Canada logo

Mount Sinai Hospital, Canada

Status

Enrolling

Conditions

Sarcoma

Treatments

Other: Early referral to palliative care
Other: Standard Treatment

Study type

Interventional

Funder types

Other

Identifiers

NCT06805669
SARC-004

Details and patient eligibility

About

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.

Enrollment

136 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

136 participants in 2 patient groups

Early Referral to Palliative Care
Experimental group
Treatment:
Other: Early referral to palliative care
Standard Treatment
Other group
Treatment:
Other: Standard Treatment

Trial contacts and locations

1

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Central trial contact

Clinical Trials Manager

Data sourced from clinicaltrials.gov

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