RecruitingNAINTERVENTIONAL

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)

This study, called SARQUALITY, is exploring if involving a palliative care team early in treatment improves the quality of life for people newly diagnosed with advanced or metastatic soft tissue sarcoma. It's a randomised study, meaning some participants will receive early palliative care alongside their usual treatment, while others will just have their usual treatment. Everyone will fill out questionnaires about their quality of life before starting treatment and every six weeks for 24 weeks. The goal is to understand if this early support makes a difference to how people feel and manage their symptoms as they go through treatment.

At a glance

Status

Recruiting

Phase

Sponsor

Mount Sinai Hospital, Canada

Enrolment target

136

Start

20 Mar 2024

Estimated completion

01 Oct 2027

Sarcoma

What is this study about?

This study, known as SARQUALITY, is designed to find out if getting support from a palliative care team early in your treatment journey makes a positive difference if you have advanced soft tissue sarcoma. Soft tissue sarcoma is a type of cancer that can appear in different parts of the body.

Usually, palliative care is often thought of as something only for the very end stages of an illness. However, this study is testing the idea that getting this kind of support much earlier could significantly improve your quality of life, help manage symptoms, and provide emotional support from the start, alongside your regular cancer treatment. The researchers want to see if this early extra support leads to better overall wellbeing.

By comparing two groups – one receiving early palliative care and standard treatment, and another receiving standard treatment alone – the study hopes to gather important information. This information could help healthcare professionals understand the best ways to support people with sarcoma in the future, ultimately aiming to improve how people feel and cope throughout their illness.

Key takeaways

This study investigates if early palliative care helps people with advanced sarcoma.
It compares early palliative care with standard treatment alone.
Participation involves filling out quality of life questionnaires over six months.
No new medicines are involved; it's about support timing.
The findings could improve future sarcoma care.

Who may be eligible?

To be able to join this study, you would need to be at least 18 years old and have a confirmed diagnosis of advanced sarcoma that hasn't started getting treatment with the aim of managing symptoms for the long term yet. Your general health and how well you can do daily activities are also considered; you should be able to complete questionnaires.

There are also some reasons why you might not be able to join. For example, if you already have a palliative care doctor involved, or if you need urgent help with symptoms or support at home that a palliative care team would provide. If you have severe memory problems, a serious mental health condition, or difficulties reading English that would prevent you from answering questions, you wouldn't be able to take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have advanced sarcoma that hasn't been treated for symptom management yet?
Can you complete questionnaires in English?
Are you able to manage your daily activities reasonably well (ECOG 0-2)?
Are you NOT already seeing a palliative care doctor?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be asked to complete some questionnaires about your quality of life before you start treatment. After that, you'll fill out the same questionnaires every six weeks for a total of 24 weeks (which is about six months). You won't be given any new medications by the study; instead, the focus is on whether getting access to palliative care services early on, alongside your usual sarcoma treatment, makes a difference. The study doesn't involve extra visits beyond what's needed for your regular treatment and questionnaire completion.

Potential risks and benefits

A potential benefit of joining this study could be receiving early support from a palliative care team, which might help improve your quality of life and manage symptoms. However, there's also a chance you could be in the group that receives standard treatment only, without the early palliative care, and your situation might not change. The main 'risk' is the time commitment required to fill out the questionnaires regularly over six months. Remember, taking part in any study is entirely voluntary, and you are free to withdraw at any time without explaining why, and this will not affect your usual medical care.

Locations (1)

Mount Sinai Hospital
Verified postcode
Toronto, Canada· Recruiting

Common questions

What is palliative care?

Palliative care is specialist support aimed at improving quality of life for people with serious illnesses. It focuses on relieving symptoms, pain, and stress, and provides emotional and practical support for you and your family.

What is sarcoma?

Sarcoma is a rare type of cancer that can develop in bones or in the soft tissues of the body, such as muscle, fat, blood vessels, nerves, and fibrous tissue.

What does 'randomised study' mean?

It means you'll be put into one of two groups by chance, like flipping a coin. One group gets early palliative care plus standard treatment, and the other gets just standard treatment. This helps make the study fair.

Will I have to take new medicines in this study?

No, this study is not testing new medicines. It's looking at the timing of when palliative care support is offered, alongside your standard cancer treatment.

How long will I be involved in the study?

If you join, you'll be involved for about 24 weeks, or six months, mainly by completing questionnaires.

How to find out more

Clinical Trials Manager

oncology.research@sinaihealth.ca 416-586-8440 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.