Simulation-Based Caregiver Education for Cancer Support

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether an education and support program can boost caregivers' confidence in caring for someone with cancer. It tests various methods of providing education and support to determine which are most beneficial for caregivers. The trial includes one-on-one teaching sessions for caregivers during the patient's radiation treatments, followed by a call two weeks later. Patients with specific cancer types who are beginning radiation therapy and have a family caregiver offering daily assistance are well-suited for this trial. As an unphased trial, it provides caregivers a unique chance to enhance their skills and confidence in a supportive setting.

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 prior data suggests that this education and support program is safe for caregivers?

Research shows that simulation-based caregiving skills training is generally safe for caregivers. Studies have found that this program is not only safe but also appreciated and helpful for caregivers of cancer patients. Caregivers reported feeling more confident in their abilities after the training sessions. No serious negative effects were reported, indicating that the program is well-tolerated and should not pose any safety risks to participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the simulation-based caregiver education because it offers a fresh approach to supporting cancer patients during their treatment. Unlike typical caregiver programs that might rely on generalized information or sporadic support, this method provides personalized, one-on-one teaching sessions tailored specifically to the caregiver's needs. These sessions are integrated with the patient's radiation treatment schedule, ensuring timely and relevant guidance. Additionally, a unique follow-up phone call two weeks post-treatment helps reinforce the learning and address any lingering questions or challenges. This hands-on, continuous support system has the potential to significantly enhance the caregiver's ability to provide effective care, ultimately benefiting the patient's overall treatment experience.

What evidence suggests that this education and support program is effective for caregivers of cancer patients?

Research has shown that training programs using simulations can be very effective for caregivers. In this trial, participants in the intervention arm will receive simulation-based caregiving skills training through three in-person, one-on-one teaching sessions, followed by a telephone booster contact. Studies have found that caregivers consider these programs safe, practical, and helpful. They report feeling more prepared and confident in their caregiving skills after participating. This training often includes important tasks like feeding and hygiene, which are essential for patient care. Caregivers also appreciate the support and information provided during these sessions. Overall, simulation-based training empowers caregivers, making them feel more capable of handling the challenges of caring for a loved one with cancer. ^{1 2 3 6 7}

Who Is on the Research Team?

Susan Mazanec, PhD

Principal Investigator

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 2 Interventions

CG/CP dyads * 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

CG(caregivers)/CP(cancer patients) dyads \- 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+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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 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]

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]

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]

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]

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]

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