NCT06805669RecruitingNot Applicable
Integrating Early Palliative Care in Advanced SARcoma Patients for Enhanced QUALITY of Life: the SARQUALITY Study
Mount Sinai Hospital, Canada1 site in 1 country136 target enrollmentStarted: March 20, 2024Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Mount Sinai Hospital, Canada
- Enrollment
- 136
- Locations
- 1
- Primary Endpoint
- To determine the difference of Health Related Quality of Life (HRQoL) for sarcoma patients who receive early palliative care versus not
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Standard Treatment
Other
Intervention: Standard Treatment (Other)
Early Referral to Palliative Care
Experimental
Intervention: Early referral to palliative care (Other)
Outcomes
Primary Outcomes
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
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).
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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