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)

ConditionSarcoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMount Sinai Hospital, Canada

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Early referral to palliative care

    Other intervention

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

  • Standard Treatment

    Other intervention

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

Treatment groups

136 Participants
are divided into 2 treatment groups
Group A: Early Referral to Palliative CareExperimental treatment 1 intervention
Group B: Standard TreatmentOther 1 intervention

Trial outcomes

Primary outcomes

1

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).

Time frame
From enrollment/baseline to 12 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

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