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

Trial Summary

What is the purpose of this trial?

Through this award, Michael Hoerger, PhD, MSCR, a psychologist at the Tulane Cancer Center in Louisiana, will lead a study called EMPOWER 3 designed to test an educational intervention to help patients understand palliative care, use it, and feel better emotionally and physically. Participants will be adults with serious cancer diagnoses. Participants will be randomized into two groups. Patients in the control group will get enhanced usual care, meaning standard cancer care and several additional healthcare-related brochures. Patients in the intervention group will get enhanced usual care plus an educational video developed by the investigators and other materials designed to increase understanding and use of palliative care. Family members of patients in the intervention group may also attend if desired. The investigators will track participants' understanding of palliative care, attitudes toward palliative care, symptoms over 6 months of follow-up, and palliative care utilization.

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 data supports the effectiveness of the treatment Multimedia Psychoeducational Intervention for Palliative Care?

Research shows that psychoeducational interventions, like the EMPOWER 2 Intervention, can improve patients' readiness for palliative care, which is known to enhance quality of life. Additionally, palliative care education is crucial for improving its use, suggesting that educational interventions can help patients better understand and integrate palliative care into their treatment plans. ^{1 2 3 4 5}

Is the educational intervention for cancer palliative care safe for humans?

The studies reviewed suggest that multimedia and psychoeducational interventions for cancer pain management and palliative care are generally safe, with no significant safety concerns reported. However, more large-scale studies are needed to confirm these findings. ^{1 2 4 6 7}

What makes the EMPOWER 3 Intervention treatment unique 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 cancer management, which can improve their readiness and quality of life. This approach is different from traditional treatments as it focuses on education and empowerment rather than just medical or physical symptom management. ^{1 2 8 9 10}

Research Team

Michael Hoerger, PhD, MSCR, MBA

Principal Investigator

Tulane University

Eligibility Criteria

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.

I am 18 years old or older.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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 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]

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]

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]

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]

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]

References

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

Integrating palliative care into self-management of breast cancer: Protocol for a pilot randomized controlled trial. [2019]

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

Increasing Readiness for Early Integrated Palliative Oncology Care: Development and Initial Evaluation of the EMPOWER 2 Intervention. [2022]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Palliative care education and its effectiveness: a systematic review. [2021]

4. England 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. [2023]

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

Translating Knowledge Into Clinical Practice: A Unique End-of-Life Nursing Education Consortium Teleconferencing Program. [2023]

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

Brief DVD-based educational intervention for patients with cancer pain: feasibility study. [2011]

7. China pubmed.ncbi.nlm.nih.gov

Use of multimedia in patient and caregiver education for cancer pain management: a literature review. [2017]

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

Education in palliative care. [2005]

9. Germany 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. [2023]

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

The effect of teaching methods in palliative care education for undergraduate nursing and medical students: a systematic review. [2022]