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)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Early referral to palliative care, Standard Treatment.
- Who it may be relevant to
- Registry conditions: Sarcoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Integrating Early Palliative Care in Advanced SARcoma Patients for Enhanced QUALITY of Life: the SARQUALITY Study
Overview
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.
Interventions
- Other Early referral to palliative care
Participant will be referred to palliative care at start of systemic treatment - Other Standard Treatment
Participants will be referred to palliative care upon appearance of uncontrollable symptoms.
Primary outcome measures
- 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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Canada · 1 center
- Mount Sinai Hospital — Toronto
Identifiers
NCT: NCT06805669 · SARC-004