RESTORE Training for End-of-Life Discussions in Cancer Care

(RESTORED Trial)

Overseen By Daryl Bainbridge, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: McMaster University

Disqualifiers: Not enrolled in program

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to develop a communication skills program for cancer doctors in training, helping them navigate difficult conversations with patients nearing the end of life. The study will test two training methods: one combines online learning with practice sessions using actors as patients, and the other relies on online learning alone. The goal is to determine which method more effectively enhances communication skills. The study will evaluate Medical Interaction and Coaching, also known as RESTORE. Medical and radiation oncology residents and fellows enrolled in certain programs with internet access are well-suited for this trial. As an unphased trial, this study offers a unique opportunity to improve doctor-patient communication skills, potentially enhancing end-of-life care.

Do I need to stop my current medications for this trial?

The protocol does not specify whether you need to stop taking your current medications.

What prior data suggests that this communication training is safe for oncology residents?

Research has shown that the RESTORE training, which includes Medical Interaction and Coaching, aims to enhance communication skills for cancer doctors in training. Although specific safety data for this educational program is unavailable, it is considered very low-risk because it is not a medical treatment. The training involves online learning and practice sessions with actors simulating patients, which participants generally receive well. Similar educational programs have reported no negative effects, suggesting that participation in this program is safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to improve how healthcare professionals communicate during end-of-life discussions in cancer care. Unlike traditional training methods that may rely heavily on theoretical knowledge, this trial uses a hands-on virtual communication curriculum. Participants engage with electronic learning modules (ELMs) and have the opportunity to practice with standardized patients (SPs), receiving personalized coaching feedback. This approach offers a more interactive and practical training experience, potentially enhancing the quality of end-of-life conversations between healthcare providers and patients.

What evidence suggests that this trial's communication training methods could be effective for end-of-life discussions in cancer care?

Research shows that effective communication training, such as the RESTORE Training in this trial, can improve outcomes for patients and their families. Participants will receive either a virtual communication curriculum with electronic learning modules (ELMs) alone or ELMs combined with skills sessions using standardized patients (SPs) and coaching feedback. Studies have found that oncologists trained in communication skills discuss palliative care (supportive care) and end-of-life issues more effectively and earlier. This leads to better experiences for patients and caregivers, including clearer decisions about end-of-life care and reduced distress. Specifically, communication training helps oncologists address difficult topics with cancer patients. This suggests that RESTORE Training, which includes online learning and practice sessions with actors, could be a valuable tool for oncologists in handling these sensitive conversations. ^{1 2 6 7 8}

Who Is on the Research Team?

Oren Levine, MD

Principal Investigator

McMaster University

Are You a Good Fit for This Trial?

This trial is for medical and radiation oncology residents and fellows at McMaster University, as well as medical oncology residents at the Universities of Ottawa and Toronto. Participants must be enrolled in these programs, speak English, have internet access, and a video-enabled computer.

Inclusion Criteria

You must be enrolled in a qualifying program, able to take part in study activities conducted in English, have access to the internet and possess video-enabled computing technology for academic purposes.

You are a medical and radiation oncology resident or fellow at McMaster University, or a medical oncology resident at either the University of Ottawa or Toronto.

Exclusion Criteria

Not enrolled in a participating training program

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants undergo virtual communication training using electronic learning modules (ELMs) and standardized patient (SP) encounters

3 months

Virtual sessions via Zoom

Follow-up

Participants are monitored for changes in communication skills and satisfaction with the training intervention

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Medical Interaction and Coaching
• RESTORE

Trial Overview

The study tests a remote communication skills curriculum called RESTORE aimed at improving end-of-life discussions by oncology residents. It's a preliminary study to see if it's feasible to do a larger trial comparing different training methods.

How Is the Trial Designed?

Group I: ELMs and virtual SP encounters Experimental Treatment 2 Interventions

A virtual communication curriculum featuring electronic learning modules (ELMs) and skills sessions with standardized patients (SPs) along with coaching feedback.

Group II: ELMs alone Active Control 1 Intervention

A virtual communication curriculum featuring electronic learning modules (ELMs) only.

Who Is Running the Clinical Trial?

McMaster University

Lead Sponsor

Trials

936

Recruited

2,630,000+

Published Research Related to This Trial

End-of-life conversations are crucial for improving the quality of life for terminally ill patients, but various barriers exist that hinder these discussions among patients, families, and healthcare professionals.

To enhance these conversations, strategies should focus on improving physicians' communication skills, adopting a patient-centered care model, prioritizing quality of life, and implementing innovative clinical approaches earlier in the care process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

End-of-life conversations: evolving practice and theory. Larson, DG., Tobin, DR.[2022]

Physicians and medical students often feel unprepared to discuss end-of-life (EOL) issues with patients, highlighting the need for improved training in this area to facilitate early and honest conversations about diagnoses and advance directives.

Effective EOL discussions can enhance patient autonomy, reduce unnecessary medical interventions, and improve overall satisfaction with care, emphasizing the importance of developing a standardized curriculum in medical education focused on EOL and palliative care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dying Well-Informed: The Need for Better Clinical Education Surrounding Facilitating End-of-Life Conversations. Sutherland, R.[2020]

Oncologists often struggle to have timely and effective conversations about goals of care with advanced cancer patients, highlighting a need for better training in these discussions.

The REMAP framework (Reframe, Expect emotion, Map out patient goals, Align with goals, Propose a plan) is designed to help oncologists engage in patient-centered conversations, ultimately leading to better end-of-life care by aligning medical recommendations with patient values.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

REMAP: A Framework for Goals of Care Conversations. Childers, JW., Back, AL., Tulsky, JA., et al.[2018]

The Four Conversations online curriculum significantly helped 54% of metastatic breast cancer patients without an advance directive to complete one by the end of the study, indicating its effectiveness in facilitating important end-of-life decisions.

While participants reported feeling more confident in their decision-making due to the program, the difference in decisional conflict scores between those who used the program and those who did not was not statistically significant, suggesting that while the program is helpful, it may not reduce decisional conflict as effectively as hoped.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Four Conversations: A Randomized Controlled Trial of an Online, Personalized Coping and Decision Aid for Metastatic Breast Cancer Patients. Smith, SK., Westbrook, K., MacDermott, K., et al.[2021]

Healthcare practitioners often delay or avoid initiating end-of-life discussions with patients, despite the existence of guidelines, due to emotional burdens and challenges such as family conflicts and prognostic uncertainty.

Training in end-of-life communication is crucial, especially for undergraduates and new healthcare practitioners, as effective communication skills are typically developed through experience rather than formal education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Are We Making Progress on Communication with People Who Are Near the End of Life in the Australian Health System? A Thematic Analysis. Trankle, SA., Shanmugam, S., Lewis, E., et al.[2021]

A systematic review of 36 studies, including 5 randomized control trials and 31 observational studies, found that no single intervention consistently reduced aggressive end-of-life care for cancer patients, highlighting a lack of effective strategies in this area.

The review identified 16 types of interventions but noted that the effectiveness of these interventions was hampered by inconsistent measurement standards and study designs, indicating a need for improved policies and research in end-of-life cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interventions to reduce aggressive care at end of life among patients with cancer: a systematic review. Abedini, NC., Hechtman, RK., Singh, AD., et al.[2020]

In a pilot study involving 763 patients aged 79 and older, a physician assistant-led discussion using an electronic tool successfully changed resuscitation preferences in 83.7% of cases, indicating its potential effectiveness in facilitating end-of-life care discussions.

The intervention required an average of 50 minutes to complete, suggesting that while it was effective, it may need to be revised for efficiency to reach more eligible patients in future studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a program using a physician assistant and an electronic patient-provider communication tool to facilitate discussions about goals of care in older adults in hospital: a pilot study. Monchis, M., Martin, C., DiDiodato, G.[2021]

Effective communication about goals of care between clinicians, patients, and families is crucial for improving patient outcomes and reducing healthcare costs, as shown in a review of 23 randomized controlled trials involving 6,376 participants.

Interventions such as patient decision aids and enhanced patient-clinician communication significantly improved understanding and dialogue, with nurse-facilitated interventions showing particular promise in enhancing the quality of end-of-life care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Communication Interventions to Improve Goal-Concordant Care of Seriously Ill Patients: An Integrative Review. Bennett, F., O'Conner-Von, S.[2021]

79% of adult patients with advanced cancer admitted to the hospital were assessed to have decisional capacity, but many lost this capacity before end-of-life discussions, leading to surrogate decision-makers participating instead.

Patients who had surrogate participation in end-of-life discussions were significantly more likely to receive aggressive life-sustaining treatments, such as mechanical ventilation and chemotherapy, indicating a potential missed opportunity for improving end-of-life care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Opportunity lost: end-of-life discussions in cancer patients who die in the hospital. Zaros, MC., Curtis, JR., Silveira, MJ., et al.[2022]

In a study analyzing communication between seriously ill patients and hospital physicians, it was found that acknowledgment of the possibility of dying was rare, but crucial for meaningful discussions about end-of-life issues.

Facilitating factors for acknowledgment included patients expressing emotional distress and physicians exploring patients' understanding of their illness, suggesting that effective communication can guide sensitive discussions about goals, fears, and palliative care options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dancing around death: hospitalist-patient communication about serious illness. Anderson, WG., Kools, S., Lyndon, A.[2021]

The pilot study involved 10 oncologists and 60 patients with stage IV solid malignancies, assessing a combined intervention that included online training for oncologists and prompt sheets for patients, which showed high participation rates (100% for oncologists and 63% for patients).

Oncologists who received the intervention demonstrated significantly more empathic responses and engaged in more discussions about prognosis and goals of care compared to those who received usual care, indicating the intervention's potential to enhance communication in end-of-life cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot Trial of a Combined Oncologist-Patient-Caregiver Communication Intervention in Singapore. Malhotra, C., Rajasekaran, T., Kanesvaran, R., et al.[2021]

About 64% of bereaved family members reported that end-of-life discussions occurred between the patient and physician, often within a month of death, highlighting the importance of these conversations in advanced cancer care.

Families who participated in end-of-life discussions experienced a slight reduction in depression and grief, and reported higher quality of end-of-life care compared to those who did not have such discussions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association Among End-Of-Life Discussions, Cancer Patients' Quality of Life at End of Life, and Bereaved Families' Mental Health. Hayashi, Y., Sato, K., Ogawa, M., et al.[2022]

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