Palliative Care Delivery Methods for Advanced Cancer

Not currently recruiting at 141 trial locations

Overseen By Olivia Tauriello

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Rochester

Disqualifiers: Previous palliative care services

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

Compensation: Varies

Number of Visits: 12

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine the best way to deliver a palliative care program called ENABLE for individuals with advanced cancer. Palliative care improves quality of life by managing symptoms, reducing stress, and providing social and spiritual support. Participants will either join a Virtual Learning Collaborative or receive Technical Assistance to evaluate which method is most effective. Ideal candidates are those diagnosed with advanced cancer within the last 90 days who have not previously received palliative care. Participants must have phone access to complete assessments and sessions. As an unphased trial, this study offers a unique opportunity to enhance palliative care delivery methods for future patients.

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 prior data suggests that these palliative care delivery methods are safe for patients with advanced cancer?

Research has shown that the ENABLE Palliative Care Program has been studied for its effects on patients with advanced cancer. These studies mainly focus on improving quality of life, managing symptoms, and providing emotional support. Although safety isn't directly mentioned, palliative care emphasizes comfort and support.

In past trials, patients experienced a better quality of life and less severe symptoms without major negative effects. Nurses lead the program, which includes regular phone sessions with a coach. This approach helps patients and caregivers manage stress and express their needs.

Overall, the ENABLE program appears well-received, with no serious negative effects reported in studies. The main goal is to reduce the stress of serious illness and improve patients' daily lives. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the ENABLE Palliative Care Program for advanced cancer because it offers a novel approach to supporting both patients and caregivers through structured phone-based coaching sessions. Unlike typical in-person palliative care, this program provides flexibility and accessibility with its remote delivery method, allowing participants to engage from the comfort of their homes. The inclusion of caregivers in the program is unique, emphasizing comprehensive support for the patient's broader support network. Additionally, by incorporating group-based learning and quality improvement initiatives in practice sites, it aims to enhance care delivery on a larger scale. This holistic and accessible approach could potentially improve quality of life for patients and their families, setting it apart from traditional palliative care models.

What evidence suggests that these palliative care delivery methods are effective for advanced cancer?

Research has shown that the ENABLE palliative care program, which participants in this trial may receive, can improve the quality of life for cancer patients. Studies have found that patients in this program reported better emotional well-being and experienced less severe symptoms than those receiving standard care. One study discovered that patients in the ENABLE program lived longer, with an average survival time of 14 months, compared to 8.5 months for those not in the program. The program focuses on easing symptoms, managing stress, and providing social support, which are crucial for living well with a serious illness. Overall, evidence suggests that ENABLE can significantly benefit people facing advanced cancer. This trial will compare the ENABLE program delivered with a Virtual Learning Collaborative to the ENABLE program delivered with Technical Assistance. ^{1 3 6 7 8}

Who Is on the Research Team?

Lisa Zubkoff, PhD

Principal Investigator

University of Rochester NCORP Research Base

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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 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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3657724/

The Project ENABLE II Randomized Controlled Trial to ... The primary endpoints were patient-reported QOL, symptom intensity, and resource utilization. Mood was a secondary outcome.

2. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/184422

Effects of a Palliative Care Intervention on Clinical ... Median survival for the intervention group was 14 months (95% CI, 10.6-18.4 months) and 8.5 months (95% CI, 7.0-11.1 months) for the usual care ...

3. uab.edu uab.edu/medicine/palliativecare/images/ProjectENABLE.pdf

Project ENABLE (Educate, Nurture, Advise Before Life Ends) Effects of a Palliative Care Intervention on Clinical Outcomes in Patients with Advanced · Cancer: The Project ENABLE II Randomized Controlled Trial. Journal ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04318886

Lay Coach-Led Early Palliative Care for Underserved ... This proposed hybrid type I randomized effectiveness-implementation trial will determine whether ENABLE Cornerstone compared to usual care can improve ...

5. ascopubs.org ascopubs.org/doi/10.1200/EDBK_100038

Why and How to Integrate Early Palliative Care Into Cutting ... A preponderance of evidence supports the early integration of palliative care with oncology care to improve outcomes for patients with advanced cancer and their ...

6. ebccp.cancercontrol.cancer.gov ebccp.cancercontrol.cancer.gov/programDetails.do?programId=3590238

Project ENABLE II Designed to enhance the quality of life for individuals with a new diagnosis of advanced-stage or recurrent cancer.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3685415/

The Project ENABLE II Randomized Controlled Trial to ... Project ENABLE II was a prospective, randomized controlled trial of an educational and care management palliative care intervention for persons with advanced ...

8. ascopubs.org ascopubs.org/doi/10.1200/OP-24-00892

Early Integration of Outpatient Palliative Care Among ... Few studies have characterized PC delivery in the outpatient setting among patients with advanced cancer within a safety-net health system.