Recruiting

Palliative Care vs. Standard Treatment

Sponsor:

Mount Sinai Hospital, Canada

Code:

NCT06805669

Conditions

Sarcoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Early referral to palliative care

Standard Treatment

Study Details

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.

Conditions

Sarcoma

Study ID

NCT06805669

Start date

Mar 20, 2024

Status verified date

Jan, 2025

Completion date

Oct, 2027

Anticipated

Primary completion date

Apr, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

136 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Early Referral to Palliative Care

other: Standard Treatment

Interventions

Early referral to palliative care

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

Standard Treatment

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

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Clinical Trials Manager

416-586-8440Oncology.Research@sinaihealth.ca

Locations

Mount Sinai Hospital

Recruiting

Toronto, Ontario, Canada, M5G 1X5

Contacts

Clinical Trials Manager

4165868440Oncology.Research@sinaihealth.ca

Principal Investigator:

Albiruni R. Abdul Razak

More Information

Sponsor

Mount Sinai Hospital, Canada

Last update posted

Feb 3, 2025

Last verified

Jan, 2025

Keywords

  • Sarcoma
  • Palliative Care

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mount Sinai Hospital, Canada on 2025-02-03.