Palliative Care Delivery Methods for Advanced Cancer

Recruiting at 131 trial locations

Overseen By Olivia Tauriello

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Rochester

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

Compensation: Varies

Number of Visits: 12

208 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial studies the delivery of the ENABLE palliative care program by two different methods called a Virtual Learning Collaborative or Technical Assistance for patients with advanced cancer and their caregivers. Palliative care is specialized medical care for people with a serious illness that occurs at the same time as other medical treatment. The purpose of palliative care is to provide relief from symptoms and stress of serious illness, to help patients and their families clarify goals of care, and to focus on social support and spiritual well-being. The focus of the ENABLE palliative care program is on living well, managing stress, patient communication of their personal values and hopes for care, social support, and symptom management. This study may help doctors find the best ways to include palliative care services into their practices and the impact of palliative care on cancer patients and their caregivers' quality of life.

Will I have to stop taking my current medications?

The trial does not specify whether you need to stop taking your current medications. It seems you can continue your cancer treatment while participating in this study.

What data supports the effectiveness of the treatment ENABLE Palliative Care Program for advanced cancer?

Research shows that palliative care, like the ENABLE program, improves the quality of life for patients with advanced cancer by addressing symptoms and planning for end-of-life care. Early integration of palliative care has been found to benefit patients, families, and healthcare systems by enhancing care quality. ^{1 2 3 4 5}

Is the ENABLE Palliative Care Program safe for humans?

The ENABLE Palliative Care Program and similar non-drug palliative care methods are generally considered safe for humans, with studies showing low rates of serious adverse events. Most adverse events in palliative care are related to disease progression rather than the intervention itself. ^{6 7 8 9 10}

What makes the ENABLE Palliative Care Program unique for advanced cancer treatment?

The ENABLE Palliative Care Program is unique because it is a nurse-led, early palliative care model that focuses on educating and supporting both patients with advanced cancer and their family caregivers. It includes components like problem-solving, advance care planning, symptom management, and self-care, which are tailored to improve the quality of life and are culturally adaptable, as seen in its adaptation for use in Singapore. ^{1 5 11 12 13}

Research Team

Lisa Zubkoff, PhD

Principal Investigator

University of Rochester NCORP Research Base

Eligibility Criteria

This trial is for patients recently diagnosed with advanced stage III/IV cancer and their caregivers. Participants must speak English, have telephone access, be able to consent, and not have received prior palliative care services. Caregivers are unpaid friends or relatives providing support. Practices need committed staff including ENABLE nurse coaches.

Inclusion Criteria

CAREGIVERS: Able to provide informed consent.

I am a caregiver and I speak English.

NCORP PRACTICE: Desire to implement ENABLE, including presence of an investigator (e.g., primary affiliate principal investigator [PI], oncology physician, Cancer Care Delivery Research [CCDR] Lead) and/or program administrator/supervisor who are willing to be key contacts.

Exclusion Criteria

I have received care focused on relieving symptoms.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Palliative Care Assessment and ENABLE Sessions

Patients undergo a palliative care assessment and participate in 6 ENABLE phone-based sessions with an ENABLE coach over 20-40 minutes. Caregivers participate in 3 ENABLE sessions.

6 months

Monthly follow-up calls

Virtual Learning Collaborative (VLC) or Technical Assistance (TA)

Practice sites participate in either a Virtual Learning Collaborative or receive Technical Assistance, involving monthly sessions for quality improvement and consultation.

15 months

Monthly sessions

Follow-up

Participants are monitored for quality of life and mood outcomes after completion of the ENABLE sessions.

24 weeks

Follow-up at 12 and 24 weeks

Treatment Details

Interventions

• ENABLE Palliative Care Program
• Technical Assistance
• Virtual Learning Collaborative

Trial Overview The study compares two methods of delivering the ENABLE palliative care program: a Virtual Learning Collaborative versus Technical Assistance. It aims to improve quality of life by managing stress, clarifying care goals, and enhancing social and spiritual well-being through various interventions like assessments and educational sessions.

Participant Groups

Group I: Group II (ENABLE palliative care program, phone calls, TA) Experimental Treatment 6 Interventions

Patients undergo a palliative care assessment, participate in 6 ENABLE phone-based sessions with an ENABLE coach over 20-40 minutes, and monthly follow-up calls for 6 months. Caregivers participate in 3 ENABLE sessions with an ENABLE coach and monthly follow-up calls for 6 months. The practice sites undergo practice-based consultation calls with an ENABLE/TA expert monthly for 15 months.

Group II: Group I (ENABLE palliative care program, phone calls, VLC) Experimental Treatment 6 Interventions

Patients undergo a palliative care assessment, participate in 6 ENABLE phone-based sessions with an ENABLE coach over 20-40 minutes, and monthly follow-up calls for 6 months. Caregivers participate in 3 ENABLE sessions with an ENABLE coach and monthly follow-up calls for 6 months. The practice sites participate in a VLC consisting of group-based learning sessions, coaching, and applied quality improvement data collection, analysis and feedback opportunities monthly for 15 months.

Who Is Running the Clinical Trial?

University of Rochester

Lead Sponsor

Trials

883

Recruited

555,000+

University of Rochester NCORP Research Base

Lead Sponsor

Trials

14

Recruited

9,100+

University of Alabama at Birmingham

Collaborator

Trials

1,677

Recruited

2,458,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

Out of 536 patients with advanced cancer, 45% were referred to palliative care (PC), with significant differences in access based on cancer type, particularly higher access for breast and gynecological cancers.

Patients referred to PC received less aggressive treatments, such as chemotherapy and intensive care, in their final weeks of life, indicating that PC may lead to a more comfortable end-of-life experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Palliative care referral and associated outcomes among patients with cancer in the last 2 weeks of life. Ledoux, M., Rhondali, W., Lafumas, V., et al.[2019]

The systematic review identified 40 operationalized and 19 non-operationalized quality measures for palliative care in cancer patients, with the most measures available for pain (12) and advance care planning (21), but very few for depression (4) and dyspnea (2).

Despite the availability of numerous measures, there is a critical need for testing these measures specifically in cancer populations, especially for pediatric cancer care, to ensure they effectively address the quality of supportive care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cancer care quality measures: symptoms and end-of-life care. Lorenz, K., Lynn, J., Dy, S., et al.[2016]

A toolkit was developed to help community cancer centers, especially in rural areas, implement early concurrent palliative care for patients with newly diagnosed metastatic cancer, guided by the RE-AIM framework.

Four specific instruments were created to measure the implementation of the ENABLE model, including tools for assessing reach, organizational readiness, costs, and clinician perceptions, which have been pilot-tested for effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing a "toolkit" to measure implementation of concurrent palliative care in rural community cancer centers. Zubkoff, L., Dionne-Odom, JN., Pisu, M., et al.[2018]

The Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) has been validated as a reliable tool for assessing symptoms and their impact on quality of life in patients undergoing phase I cancer trials, based on a study of 479 patients.

There were significant correlations between PRO-CTCAE items and measures of psychological distress and quality of life, particularly for mood-related items, indicating that PRO-CTCAE can effectively capture the patient experience in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using Patient-Reported Outcomes to Describe the Patient Experience on Phase I Clinical Trials. Sedhom, R., Ferrell, B., Ruel, N., et al.[2022]

In a study of 65 hospice and palliative care patients, 78% had events that led to their admission, and 62% experienced additional adverse events during their stay, highlighting the prevalence of symptomatic adverse events in this population.

The study found an average of 0.13 adverse events per patient per day, indicating that even in the absence of initial events, patients are at high risk for complications, which can worsen their overall health status.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events in hospice and palliative care: a pilot study to determine feasibility of collection and baseline rates. Currow, DC., Agar, MR., To, TH., et al.[2011]

The paper emphasizes the importance of developing robust serious adverse event (SAE) reporting procedures in non-pharmaceutical palliative care trials, as patients often face high risks of hospitalization or death due to their underlying conditions rather than the trial interventions.

Recommendations for improving SAE management include allowing sufficient planning time, defining what constitutes a serious adverse event for the specific study population, and refining reporting procedures throughout the trial to enhance patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What should we report? Lessons learnt from the development and implementation of serious adverse event reporting procedures in non-pharmacological trials in palliative care. Dunleavy, L., Collingridge Moore, D., Korfage, I., et al.[2021]

The ENABLE palliative care model was found to be culturally acceptable among patients with advanced cancer and their caregivers in Singapore, highlighting the need for psychosocial support earlier in the illness trajectory.

Participants recommended modifications to the program, such as ensuring content is suitable for patients who may not fully understand their diagnosis and preferring face-to-face sessions to enhance rapport with healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adapting ENABLE for patients with advanced cancer and their family caregivers in Singapore: a qualitative formative evaluation. Yang, GM., Dionne-Odom, JN., Foo, YH., et al.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

Palliative care referral and associated outcomes among patients with cancer in the last 2 weeks of life. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Cancer care quality measures: symptoms and end-of-life care. [2016]

3. China pubmed.ncbi.nlm.nih.gov

A review of the trials which examine early integration of outpatient and home palliative care for patients with serious illnesses. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Using palliative care assessment tools to influence and enhance clinical practice. [2015]

5. England pubmed.ncbi.nlm.nih.gov

Developing a "toolkit" to measure implementation of concurrent palliative care in rural community cancer centers. [2018]

6. England pubmed.ncbi.nlm.nih.gov

Adverse Drug Reactions in Palliative Care. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Participant Safety in Multisite, Randomized, Double-Blind, Placebo-Controlled Clinical Trials in Hospice/Palliative Care: Data from the Contracted Studies of the Australian National Palliative Care Clinical Studies Collaborative. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Using Patient-Reported Outcomes to Describe the Patient Experience on Phase I Clinical Trials. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Adverse events in hospice and palliative care: a pilot study to determine feasibility of collection and baseline rates. [2011]

10. England pubmed.ncbi.nlm.nih.gov

What should we report? Lessons learnt from the development and implementation of serious adverse event reporting procedures in non-pharmacological trials in palliative care. [2021]

11. England pubmed.ncbi.nlm.nih.gov

Adapting ENABLE for patients with advanced cancer and their family caregivers in Singapore: a qualitative formative evaluation. [2021]

12. England pubmed.ncbi.nlm.nih.gov

Outpatient palliative care referral system (PCRS) for patients with advanced cancer: an impact evaluation protocol. [2022]

13. England pubmed.ncbi.nlm.nih.gov

First referral to an integrated onco-palliative care program: a retrospective analysis of its timing. [2020]