Simulation-Based Caregiver Education for Cancer Support

Recruiting at 1 trial location

Overseen By Susan Mazanec, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Case Comprehensive Cancer Center

Disqualifiers: No caregiver, Hospice care, Active cancer treatment

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

Compensation: Varies

Number of Visits: 6

488 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to learn whether an education and support program can help caregivers feel more confident in technical and communication skills needed to care for a person with cancer. Patients with cancer and their caregivers face many challenges. These include learning about cancer and its treatment, coping with symptoms from illness and treatment side effects, making adjustments to usual activities, and managing the emotional effects of having a serious illness. This study is testing whether different forms of education and support can help caregivers feel better prepared. To find out if education about caregiving and different kinds of support are effective, study personnel will compare approaches to help find ways to improve the services that are provided to caregivers during cancer treatment. About 180 patients and their caregivers at the Seidman Cancer Center will take part in this study. Participating in research is voluntary and this study is funded by the National Institute of Health.

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

The trial protocol does not specify whether you need to stop taking your current medications. However, caregivers undergoing active cancer treatment are excluded, except for those on hormonal treatment.

What data supports the idea that Simulation-Based Caregiver Education for Cancer Support is an effective treatment?

The available research shows that caregivers prefer multiple training methods, including in-person instruction and online videos, which are part of Simulation-Based Caregiver Education. This suggests that the treatment is effective because it aligns with caregivers' learning preferences, making it more likely they will engage with and benefit from the training. Additionally, the research highlights the importance of education in reducing stress and anxiety for cancer patients, which implies that well-trained caregivers can better support patients, potentially leading to improved outcomes. ^{1 2 3 4 5}

What safety data exists for simulation-based caregiver education in cancer support?

The research does not provide direct safety data for simulation-based caregiver education specifically for cancer support. However, it highlights the potential of simulation-based education to improve patient safety in oncology by empowering students and caregivers with skills to reduce medical errors and adverse events. Additionally, a safety checklist for simulated participants in education was developed to ensure safety during simulation training. ^{6 7 8 9 10}

Is the treatment One-on-one teaching sessions a promising treatment for caregivers in cancer support?

Yes, One-on-one teaching sessions are promising because they help caregivers learn better through personalized instruction. This approach can improve caregivers' skills and confidence, making them more effective in supporting cancer patients. ^{1 11 12 13 14}

Research Team

Susan Mazanec, PhD

Principal Investigator

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Eligibility Criteria

This trial is for caregivers of cancer patients who are starting their first radiation therapy. The patient must have certain types of cancer like rectal, esophageal, or specific stages of lung and head/neck cancers. Caregivers should be the primary support person but can't participate if they're receiving active cancer treatment themselves (except hormonal), or if the patient is in hospice care.

Inclusion Criteria

My cancer is in the rectum, anus, esophagus, lung, or head/neck and is at an early to mid-stage.

I am undergoing my first round of radiation therapy.

Has an identified family CG who is willing to participate.

Exclusion Criteria

CGs of patients who are receiving hospice care will be excluded because of the patient's poor prognosis and multiple issues associated with end-of-life care.

Patients who do not have a caregiver will be excluded.

I am not currently receiving cancer treatment, except for hormonal therapy.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Intervention

Three in-person, one-on-one teaching sessions with the caregiver during radiation treatments, followed by a telephone booster contact 2 weeks post-treatment

7 weeks

3 visits (in-person), 1 visit (telephone)

Follow-up

Participants are monitored for caregiver and patient outcomes, including HRQOL and anxiety, at 4 and 20 weeks post-treatment

20 weeks

2 visits (in-person or virtual)

Treatment Details

Interventions

• One-on-one teaching sessions
• Telephone booster contact

Trial Overview The study tests an education and support program to see if it helps caregivers feel more confident in caring for someone with cancer. It involves comparing different teaching methods, including one-on-one sessions and follow-up calls, to find better ways to prepare caregivers.

Participant Groups

Group I: Intervention Experimental Treatment 2 Interventions

* All participants will be screened for health literacy using a 4-item Brief Health Literacy Screening Tool (BRIEF) * Three in-person, one-on-one teaching sessions with the caregiver during radiation treatments, followed by a telephone booster contact 2 weeks post-treatment.

Group II: Control - Standard of Care Active Control 1 Intervention

- All participants will be screened for health literacy using a 4-item Brief Health Literacy Screening Tool (BRIEF)

Who Is Running the Clinical Trial?

Case Comprehensive Cancer Center

Lead Sponsor

Trials

472

Recruited

33,400+

Findings from Research

Oncology nurses are essential in providing education and training to caregivers of adult cancer patients, highlighting their supportive role in both hospital and home settings.

Informal caregivers showed a strong preference for diverse training methods, particularly favoring in-person instruction, online videos, and reading materials to enhance their caregiving skills.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Caregiver Education and Training: Learning Preferences of Informal Caregivers of Adult Care Recipients. Mollica, MA., Kent, EE.[2021]

A quality improvement project at a community cancer center focused on enhancing patient education for cancer patients, addressing the high anxiety levels that can hinder information retention.

The pilot study introduced a one-hour separate patient education visit, which received positive feedback from both patients and oncology nurses, indicating satisfaction with the standardized education approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of an evidence-based education practice change for patients with cancer. Portz, D., Johnston, MP.[2014]

Palliative care simulations using standardized patients significantly improved the knowledge and skills of newly hired oncology nurses, particularly in pain management and communication, compared to traditional training methods.

The simulation group also demonstrated enhanced critical thinking abilities and higher satisfaction with their training, indicating that this approach is an effective strategy for preparing oncology nurses for real-world scenarios.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of palliative care simulation in newly hired oncology nurses' training. Kang, D., Zhang, L., Jin, S., et al.[2022]

Cancer patient education should go beyond just providing information; it must also include teaching coping skills and new strategies to manage the disease, which can lead to better treatment adherence and reduced anxiety.

Focusing on the different phases of cancer care can help identify essential educational content, and ongoing research is crucial for developing effective teaching methods and evaluating their impact on patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Information and education across the phases of cancer care. Adams, M.[2019]

The development of simulation-based learning experiences using standardized patients significantly enhances nursing students' ability to apply evidence-based principles in oncology symptom management, as evidenced by positive feedback from faculty and students.

Students found the simulations realistic and innovative, although they noted the need for more time to fully engage with the simulations, prompting plans for future revisions to improve the learning experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Standardized Patient Simulation to Facilitate Learning in Evidence-Based Oncology Symptom Management. Ross, JG., Burrell, SA.[2018]

A 1-day patient safety program for third-year medical students, which included online modules and simulation scenarios, was well-received with an average evaluation score of 4.2/5, indicating its effectiveness in teaching safety principles.

The program increased awareness of patient safety issues among students, with 59% reporting they were previously unaware of system-based safety approaches, and it empowered them to act on safety concerns, potentially reducing adverse events in oncology care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advancing the Future of Patient Safety in Oncology: Implications of Patient Safety Education on Cancer Care Delivery. James, TA., Goedde, M., Bertsch, T., et al.[2018]

The development of a safety checklist for simulated participants (SPs) in simulation-based education (SBE) led to 100% of SPs feeling safe during training sessions, indicating its effectiveness in enhancing safety protocols.

SPs reported a significant increase in their confidence in safety, with ratings rising from an average of 6.8/10 to 9.2/10 after using the checklist, demonstrating its positive impact on their overall experience during simulations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Content validity test of a safety checklist for simulated participants in simulation-based education in the United Kingdom: a methodological study Bradley, M.[2022]

An 11-minute educational DVD combined with a group discussion led by an oncology nurse effectively improved patients' understanding of chemotherapy side effects and self-care management.

Surveys conducted after the class and at an eight-week follow-up indicated that this approach empowered patients and families, enhancing their confidence in managing side effects of chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Empowering individuals to self-manage chemotherapy side effects. Fee-Schroeder, K., Howell, L., Kokal, J., et al.[2022]

Medication errors in chemotherapy are common and can lead to significant harm, especially with the rise of outpatient treatments where patients or caregivers often handle drug administration.

Involving patients in error prevention can be effective, as they can observe and report mistakes; however, they need proper information and encouragement to actively participate in ensuring their safety during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medication errors in chemotherapy: incidence, types and involvement of patients in prevention. A review of the literature. Schwappach, DL., Wernli, M.[2022]

A study involving 334 perioperative surgical staff across 12 facilities showed that simulation-based team training significantly improved teamwork scores by an average of 18%, indicating enhanced collaboration among staff.

Communication ratings also increased by 16% after the training, demonstrating that such simulation exercises can effectively boost both teamwork and communication skills in a clinical setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of simulation-based crew resource management training on measurable teamwork and communication among interprofessional teams caring for postoperative patients. Paull, DE., Deleeuw, LD., Wolk, S., et al.[2016]

Clinical simulation is an effective educational tool for both novice and experienced oncology nurses, helping them understand the complexities of caring for acutely ill cancer patients.

The paper outlines specific simulation scenarios that address common oncologic emergencies, providing practical guidance for developing and implementing a simulation program to enhance nursing care quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using human simulation in the oncology clinical practice setting. Kuhrik, NS., Kuhrik, M., Rimkus, CF., et al.[2019]

A 1-hour online educational module based on the COMFORT™ SM communication curriculum significantly improved communication knowledge, attitudes, and behaviors among 128 undergraduate nursing students, with p-values indicating strong statistical significance (p < .000).

The module effectively taught students how to engage with family caregivers of cancer patients, with over 75% accuracy in knowledge-based responses to case studies, demonstrating its potential as a valuable tool in nursing education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Caring for Family Caregivers: a Pilot Test of an Online COMFORT&#8482; SM Communication Training Module for Undergraduate Nursing Students. Wittenberg, E., Goldsmith, JV., Williams, Y., et al.[2023]

Standardized education through the Oncology CarePartner Program significantly improved caregivers' overall well-being, as measured by the Bakas Caregiving Outcomes Scale, with notable increases in scores from hospital admission to discharge and 30 days post-discharge.

Despite the positive impact on caregiver well-being, the program did not significantly reduce the time spent or difficulty associated with caregiving tasks, indicating a need for further educational adjustments or different evaluation methods to address these specific challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of education on caregiver burden on two inpatient oncology units. Creedle, C., Leak, A., Deal, AM., et al.[2022]

The introduction of simulation-based workshops in the Johns Hopkins Hematology/Oncology Fellowship Training Program significantly improved first-year fellows' comfort with essential clinical skills and patient-centered communication, as indicated by pre- and post-workshop surveys.

These workshops, which included practical training in chemotherapy writing and procedures like bone marrow biopsies, are believed to enhance patient care and reduce stress for trainees, highlighting the need for ongoing evaluation of their long-term impact.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Growing Pains: a Simulation-Based Curriculum for Improving the Transition to Hematology/Oncology Fellowship. Reiss, KA., Rangachari, D., Cosgrove, D., et al.[2018]

References

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

Caregiver Education and Training: Learning Preferences of Informal Caregivers of Adult Care Recipients. [2021]

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

Implementation of an evidence-based education practice change for patients with cancer. [2014]

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

Effectiveness of palliative care simulation in newly hired oncology nurses' training. [2022]

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

Information and education across the phases of cancer care. [2019]

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

Standardized Patient Simulation to Facilitate Learning in Evidence-Based Oncology Symptom Management. [2018]

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

Advancing the Future of Patient Safety in Oncology: Implications of Patient Safety Education on Cancer Care Delivery. [2018]

7. Korea (South) pubmed.ncbi.nlm.nih.gov

Content validity test of a safety checklist for simulated participants in simulation-based education in the United Kingdom: a methodological study [2022]

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

Empowering individuals to self-manage chemotherapy side effects. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Medication errors in chemotherapy: incidence, types and involvement of patients in prevention. A review of the literature. [2022]

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

The effect of simulation-based crew resource management training on measurable teamwork and communication among interprofessional teams caring for postoperative patients. [2016]

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

Using human simulation in the oncology clinical practice setting. [2019]

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

Caring for Family Caregivers: a Pilot Test of an Online COMFORT&#8482; SM Communication Training Module for Undergraduate Nursing Students. [2023]

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

The impact of education on caregiver burden on two inpatient oncology units. [2022]

14. England pubmed.ncbi.nlm.nih.gov

Growing Pains: a Simulation-Based Curriculum for Improving the Transition to Hematology/Oncology Fellowship. [2018]