Early Palliative Care for Sarcoma

(SARQUALITY Trial)

Overseen By Clinical Trials Manager

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mount Sinai Hospital, Canada

Disqualifiers: Cognitive impairment, Psychiatric disorder, Drug abuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 24 weeks

136 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether starting palliative care early can help people with advanced sarcoma feel better during treatment. Palliative care focuses on improving quality of life by managing symptoms and providing support, without aiming to cure the disease. The trial includes two groups: one receiving standard treatment and the other referred to palliative care earlier. This trial may suit adults with advanced sarcoma who have not yet received treatment specifically to ease symptoms and who can complete regular quality of life questionnaires. As an unphased trial, this study offers a unique opportunity for patients to contribute to understanding how early palliative care can enhance quality of life.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that early referral to palliative care is safe for patients with advanced sarcoma?

Research has shown that starting palliative care early is safe and well-received by patients. Studies have found that patients who begin palliative care early often enjoy a better quality of life. No major negative effects are linked to early palliative care itself. Instead, it enhances comfort and support during treatment. As a result, patients usually find the experience positive and helpful. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about early referral to palliative care for sarcoma because it offers a proactive approach to improving quality of life. Unlike traditional treatments that primarily focus on targeting the tumor itself, early palliative care aims to address the physical, emotional, and psychological needs of patients from the onset of diagnosis. This approach can potentially enhance patient well-being, reduce distress, and improve overall treatment experiences. By integrating palliative care early, researchers hope to provide more holistic support, leading to better patient outcomes and satisfaction.

What evidence suggests that early referral to palliative care improves quality of life for patients with advanced sarcoma?

Research has shown that starting palliative care early can improve the quality of life for patients with advanced sarcoma. In this trial, participants will receive either standard treatment or an early referral to palliative care. Studies have found that early palliative care helps patients feel more comfortable and less stressed. It also links to better overall care and even longer survival. Overall, evidence supports that early palliative care can make a significant positive difference for those with advanced sarcoma. ^{1 3 6 7 8}

Who Is on the Research Team?

Albiruni R. Abdul Razak

Principal Investigator

MOUNT SINAI HOSPITAL

Are You a Good Fit for This Trial?

This trial is for patients newly diagnosed with advanced or metastatic soft tissue sarcoma. Participants should be willing to complete quality of life questionnaires before and during treatment.

Inclusion Criteria

Willing/able to complete questionnaires

Life expectancy > 6 months

Signed written and voluntary informed consent

Exclusion Criteria

I am able to understand and provide consent for my treatment.

Active psychiatric disorder or drug abuse

I need urgent help at home or symptom management from a palliative care team.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive standard treatment with or without early palliative care

24 weeks

Quality of life questionnaires every 6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Early referral to palliative care

Trial Overview

The study is testing if early involvement of palliative care alongside standard cancer treatment improves the quality of life compared to just standard treatment in patients with advanced sarcoma.

How Is the Trial Designed?

Group I: Standard Treatment Experimental Treatment 1 Intervention

Group II: Early Referral to Palliative Care Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Mount Sinai Hospital, Canada

Lead Sponsor

Trials

210

Recruited

70,700+

Published Research Related to This Trial

The Danish Palliative Care Trial (DanPaCT) is a multicenter trial involving 300 patients with metastatic cancer, aiming to determine if early referral to specialized palliative care (SPC) improves their symptoms and overall quality of life.

This trial is significant as it is the first to explore the effects of screening-based early SPC for a wide range of cancer diagnoses, potentially addressing the unmet palliative needs of advanced cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomised, multicentre clinical trial of specialised palliative care plus standard treatment versus standard treatment alone for cancer patients with palliative care needs: the Danish palliative care trial (DanPaCT) protocol. Johnsen, AT., Damkier, A., Vejlgaard, TB., et al.[2021]

Early palliative care for patients with metastatic cancer, initiated at the time of diagnosis, can significantly improve quality of life and symptom management.

This approach may also enhance overall patient satisfaction and potentially extend survival, highlighting the importance of integrating palliative care early in cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PURLs. Palliative care: earlier is better. Rowland, K., Schumann, SA.[2021]

In a study involving 524 family members of veterans, those who received palliative consultations reported significantly better overall care outcomes in the last month of life, with scores averaging 65 compared to 54 for those without consultations.

Earlier palliative consultations were linked to even better outcomes, particularly in communication and emotional support, highlighting the importance of timely palliative care interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Do palliative consultations improve patient outcomes? Casarett, D., Pickard, A., Bailey, FA., et al.[2022]

In a study of 152 surgical oncology patients, those receiving hospital-based early palliative care showed better outcomes in pain management and symptom distress over 12 months compared to standard care, although these differences were not statistically significant.

Patients in the palliative care group reported improved communication, emotional support, and pain management, highlighting the potential benefits of integrated palliative care services in enhancing patient experience and resources for pain control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Palliative care outcomes in surgical oncology patients with advanced malignancies: a mixed methods approach. Wallen, GR., Baker, K., Stolar, M., et al.[2021]

Early palliative care, recommended in international guidelines, significantly improves patients' quality of life and reduces symptom burden, as confirmed by a meta-analysis of seven randomized studies.

There is a trend indicating that early palliative care may also reduce depressive disorders and potentially increase overall survival, while benefiting patients' relatives and decreasing aggressive end-of-life care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Early palliative care in oncology]. Bouleuc, C., Burnod, A., Angellier, E., et al.[2019]

The 'Surprise'-Question is a useful tool for haemato-oncologists to promote patient-centered care and facilitate discussions about palliative care, as it encourages reflection on patients' goals and needs.

While the 'Surprise'-Question is easy to use, barriers such as prognostic uncertainty, time constraints, and communication skills can hinder its integration into daily practice, highlighting the need for further training and research involving patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Space for intuition - the 'Surprise'-Question in haemato-oncology: Qualitative analysis of experiences and perceptions of haemato-oncologists. Gerlach, C., Goebel, S., Weber, S., et al.[2020]

A study involving 146 patients with newly diagnosed late-stage cancers found that integrating palliative care through multidisciplinary teams did not significantly change primary patient-reported outcomes like symptoms and health distress compared to usual care.

Despite the lack of significant differences, both groups experienced stable or improved physical and emotional symptoms over time, suggesting that comprehensive care approaches can maintain or enhance patient well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Advanced Practice Nurse Coordinated Multidisciplinary Intervention for Patients with Late-Stage Cancer: A Cluster Randomized Trial. McCorkle, R., Jeon, S., Ercolano, E., et al.[2021]

A total of 3234 patients were referred to specialized palliative care services over 13 years, with a concerning 52.7% referred in the last 30 days of life, highlighting the need for earlier referrals.

There has been a positive trend in early referrals to palliative care, with an increase in patients referred more than 3 months before death, suggesting improvements in oncological practice over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trends in specialized palliative care referrals at an oncology center from 2007 to 2019. Boltezar, L., Novakovic, BJ., Moltara, ME.[2021]

Citations

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This study aims to determine whether EPC alongside standard oncological care (SOC) improves PROs for patients with advanced sarcoma compared to usual care.

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The goal of this study is to learn whether early referral to palliative care improves quality of life for patients with advanced sarcoma. Participants ...

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Early Palliative Care for Sarcoma (SARQUALITY Trial)

In a study involving 524 family members of veterans, those who received palliative consultations reported significantly better overall care outcomes in the last ...

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asco.org

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Patient factors associated with early vs late referral to ...

Early referral has been associated with improved quality of life, survival and a reduction in healthcare utilization at the end of life. We sought to determine ...

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Early Integration of Outpatient Palliative Care Among ...

Outcomes assessed included (1) receipt of PC referral ≤8 weeks after diagnosis, (2) receipt of any PC referral, and (3) PC visit completion.

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ascopubs.org

ascopubs.org/doi/10.1200/OP-25-00479

Re-Examining Early in Early Palliative Care

Nevertheless, the authors conclude that the results confirm low rates of outpatient palliative care referral as a significant barrier to early ...

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sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0033350621001293

Palliative care referral in cancer patients with regard to ...

This study assessed the cumulative incidence of first hospital-based palliative care (HPC) referral, as well as the influence of patient-, tumor-, and care- ...