Educational Intervention for Cancer Palliative Care

(EMPOWER 3 Trial)

Recruiting at 1 trial location

Overseen By Michael Hoerger, PhD, MSCR, MBA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Tulane University

Disqualifiers: Specialty palliative care, Hospice, Significant psychiatric, others

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

Compensation: Varies

Number of Visits: 15

172 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help people with serious cancer diagnoses understand and use palliative care, which focuses on improving quality of life and managing symptoms. Participants will be divided into two groups: one will receive standard cancer care plus additional educational materials, while the other will also watch an educational video about palliative care, part of the Multimedia Psychoeducational Intervention. The study will track participants' understanding of palliative care and its effects on their symptoms and attitudes over six months. Suitable candidates include adults in southeast Louisiana with advanced cancer, new cancer diagnoses, or severe symptoms like pain or depression.

As an unphased trial, this study offers a unique opportunity to enhance understanding of palliative care and improve quality of life.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on educational interventions, so it's likely you can continue your current treatments, but you should confirm with the trial organizers.

What prior data suggests that this educational intervention is safe for cancer patients?

Research has shown that multimedia educational tools, like the one in this study, are generally safe and easy to handle. One study found that a single video session about palliative care improved understanding without negative effects. Another study demonstrated that similar video and text tools increased knowledge among adults, with no reported problems. These findings suggest that the educational materials used in this trial effectively increase understanding and are safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new way to support cancer patients through a Multimedia Psychoeducational Intervention. Unlike traditional palliative care, which often focuses just on physical symptoms, this approach aims to address psychological and educational needs using multimedia tools. By enhancing usual care with this intervention, the goal is to improve patients' overall well-being and understanding of their condition. This could lead to more comprehensive support for patients, making their experience more manageable and informed.

What evidence suggests that this educational intervention is effective for cancer palliative care?

Research has shown that educational programs, such as the Multimedia Psychoeducational Intervention tested in this trial, can enhance understanding and use of palliative care. Participants in this trial may receive this intervention alongside Enhanced Usual Care. One study found that videos and written materials increased adults' knowledge of palliative care. Another study demonstrated that a single video session clarified palliative care for patients' friends and families. These programs aim to improve health literacy, helping people better understand health information. This can lead to improved emotional and physical well-being for patients facing serious cancer diagnoses. ^{1 2 3 6 7}

Who Is on the Research Team?

Michael Hoerger, PhD, MSCR, MBA

Principal Investigator

Tulane University

Are You a Good Fit for This Trial?

This trial is for adults in southeast Louisiana with serious cancer diagnoses, including various advanced stages of lung, hematologic malignancies, melanoma, leukemia, lymphoma, multiple myeloma, breast and genitourinary cancers. They must have been diagnosed or shown progression in the last 90 days and experience severe symptoms like pain or depression.

Inclusion Criteria

I'm sorry, but I need more information about the specific criteria you would like me to summarize. Please provide more details or the full text of the criterion you would like me to simplify.

I have severe heart, lung, kidney, or liver disease.

My breast cancer is at stage IV.

Exclusion Criteria

Unlikely to complete any follow-up surveys

Significant psychiatric or other co-morbid disease that would prohibit informed consent or participation in the study

I have been in palliative care or hospice before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive either enhanced usual care or enhanced usual care plus a multimedia psychoeducational intervention

1 day

1 visit (in-person)

Follow-up

Participants are monitored for understanding of palliative care, attitudes, symptoms, and utilization over time

6 months

Multiple follow-up assessments at 14, 90, and 180 days

What Are the Treatments Tested in This Trial?

Interventions

• Enhanced Usual Care
• Multimedia Psychoeducational Intervention

Trial Overview The study tests an educational intervention to improve understanding and use of palliative care among cancer patients. One group receives standard care plus brochures; the other gets this plus a special video and materials on palliative care. Family members can also participate in the intervention group.

How Is the Trial Designed?

Group I: Multimedia Psychoeducational Intervention + Enhanced Usual Care Experimental Treatment 2 Interventions

Intervention participants receive the Multimedia Psychoeducational Intervention in addition to Enhanced Usual Care

Group II: Enhanced Usual Care Experimental Treatment 1 Intervention

Control participants receive Enhanced Usual Care

Who Is Running the Clinical Trial?

Tulane University

Lead Sponsor

Trials

129

Recruited

259,000+

American Cancer Society, Inc.

Collaborator

Trials

237

Recruited

110,000+

University Medical Center-New Orleans

Collaborator

Trials

3

Recruited

230+

Published Research Related to This Trial

Palliative care education encompasses various important areas, including pain management, communication skills, and psychosocial care, which are crucial for effective patient support.

Effective educational planning in palliative care requires clearly defined objectives and the use of diverse learning formats, supported by a wealth of available educational resources.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Education in palliative care. Weissman, DE., Blust, L.[2005]

Multimedia interventions for educating cancer patients and caregivers about pain management show promising benefits over traditional educational methods, based on a review of 7 relevant studies, including 5 randomized controlled trials.

Despite the positive indications of multimedia tools improving pain-related outcomes, the evidence is limited and derived from lower-quality studies, highlighting the need for more comprehensive research to validate these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of multimedia in patient and caregiver education for cancer pain management: a literature review. Lam, M., Choi, M., Lam, HR., et al.[2017]

A 6-month educational rotation in specialized palliative care significantly improved physicians' knowledge and self-efficacy in palliative care, with knowledge scores increasing from 81.1% to 86.5% and self-efficacy scores rising from 38 to 50 points.

Extending the rotation to 12 months did not result in significantly greater improvements compared to the 6-month rotation, suggesting that 6 months may be sufficient for effective training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The OUTREACH study: oncologists of German university hospitals in rotation on a palliative care unit-evaluation of attitude and competence in palliative care and hospice. Biersching, T., Schweda, A., Oechsle, K., et al.[2023]

An innovative online educational program for palliative care professionals, involving eight monthly teleconferences, effectively enhanced knowledge and networking among participants from nine countries, focusing on real clinical cases.

Participants reported that the interactive discussions not only deepened their understanding of palliative care principles but also motivated them to implement changes in their clinical practice, ultimately improving patient care for those with serious illnesses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Translating Knowledge Into Clinical Practice: A Unique End-of-Life Nursing Education Consortium Teleconferencing Program. Mitrea, N., Brown, B., Charpentier, M., et al.[2023]

A scoping review of 16 studies revealed that digitally enabled psychosocial interventions, such as cognitive behavioral therapy and emotional support, are being effectively delivered to adults with life-shortening illnesses and their caregivers, using various digital tools like telephones and websites.

The COVID-19 pandemic has increased the adoption of these digital interventions, highlighting a growing interest in innovative approaches to provide psychosocial support in palliative care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What are the digitally enabled psychosocial interventions delivered by trained practitioners being offered to adults with life-shortening illnesses and palliative care needs and their informal and professional caregivers? A scoping review. Wood, M., Walshe, C., McCullagh, A.[2023]

The study tests a psycho-educational intervention called Managing Cancer Care (MCC) aimed at improving breast cancer patients' understanding of palliative care, with plans to enroll 60 patients, including 50% from minority backgrounds.

MCC is designed to enhance patients' self-management skills and confidence in discussing care options, potentially leading to better integration of palliative care in their treatment, which may improve both quality of life and healthcare utilization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrating palliative care into self-management of breast cancer: Protocol for a pilot randomized controlled trial. Schulman-Green, D., Linsky, S., Jeon, S., et al.[2019]

Different teaching methods in palliative care education, such as simulations and problem-based learning, significantly improved students' attitudes and knowledge about caring for dying patients, as shown in a systematic review of 16 articles.

Game-based interventions were particularly effective in reducing students' fear of death and enhancing their communication skills with dying patients and their families, highlighting the importance of innovative educational approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of teaching methods in palliative care education for undergraduate nursing and medical students: a systematic review. Hökkä, M., Rajala, M., Kaakinen, P., et al.[2022]

The EMPOWER 2 intervention, developed with input from 21 stakeholders and tested with 10 patients, effectively increased knowledge about palliative care by 83.1% and improved attitudes towards it by 18.9 points, indicating its potential to enhance patient readiness for palliative care.

The intervention was highly acceptable to stakeholders (3.78/4.00) and successfully met feasibility criteria, enrolling 10 patients within 14 days with an 83.3% consent rate, suggesting it can be implemented in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Increasing Readiness for Early Integrated Palliative Oncology Care: Development and Initial Evaluation of the EMPOWER 2 Intervention. Perry, LM., Sartor, O., Malhotra, S., et al.[2022]

A brief DVD-based educational intervention for cancer pain management in palliative care patients showed significant improvements in pain scores, with a 9.6% reduction in Brief Pain Inventory (BPI) scores and a 17% reduction in Patient Pain Questionnaire (PPQ) scores after one week.

The study, which included 15 patients and 10 caregivers, indicates that such educational interventions are feasible and may enhance pain control in patients with advanced cancer, warranting further investigation in a larger multicenter trial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brief DVD-based educational intervention for patients with cancer pain: feasibility study. Capewell, C., Gregory, W., Closs, S., et al.[2011]

Palliative care education (PCE) programs significantly enhance the knowledge, attitudes, and confidence of healthcare professionals and family caregivers regarding palliative care, as evidenced by a systematic review of 39 studies published over 50 years.

The study highlights the need to expand PCE beyond healthcare professionals to include the general public and policymakers, emphasizing its importance as a public health approach to improve the utilization of palliative care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Palliative care education and its effectiveness: a systematic review. Li, WW., Chhabra, J., Singh, S.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04733469

EMPOWER 3: Improving Palliative Care Health Literacy ... The Multimedia Psychoeducational Intervention includes the following: A multimedia educational video about palliative care that is individually tailored to each ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8526633/

Increasing Readiness for Early Integrated Palliative ... A second RCT (33) found that video and text-based psychoeducational interventions increased knowledge of palliative care in a non-clinical sample of 152 adults.

3. sciencedirect.com sciencedirect.com/science/article/pii/S0738399125005890

Impact of a psychoeducational intervention to improve ... This study demonstrates that a single-session, psychoeducational video can improve understanding of palliative care among close friends and families of those ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6558986/

Multimedia Psychoeducation for Cancer Patients Eligible ... Multimedia Psychoeducation for Cancer Patients Eligible for Clinical Trials: A ... Effects of a brief multimedia psychoeducational intervention on the ...

5. acsjournals.onlinelibrary.wiley.com acsjournals.onlinelibrary.wiley.com/doi/full/10.1002/cncr.31771

Multimedia psychoeducation for patients with cancer who are ... Multimedia psychoeducation for patients with cancer who are ... Effects of a brief multimedia psychoeducational intervention on the ...

6. withpower.com withpower.com/trial/phase-neoplasms-2-2021-f89d2

Educational Intervention for Cancer Palliative Care The EMPOWER 3 Intervention is unique because it uses multimedia psychoeducational tools to help patients understand and integrate palliative care into their ...

7. tulane.trialstoday.org tulane.trialstoday.org/trial/NCT04733469

Improving Palliative Care Health Literacy and Utilization The Multimedia Psychoeducational Intervention includes the following: - A multimedia educational video about palliative care that is ...