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Simulation-Based Caregiver Education for Cancer Support

N/A

Recruiting

Led By Susan Mazanec, PhD

Research Sponsored by Case Comprehensive Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of stage I, II, III cancers of the rectum, anus, and esophagus; stage III NSCLC; and stage I - IV A/B head/neck (tongue, gum, oral cavity, nasopharynx, oropharynx, hypopharynx, parotid, or larynx).

Receiving their first course of radiation therapy.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at baseline, at end of treatment (average of seven weeks), and at 4 and 20 weeks post treatment

Awards & highlights

Study Summary

This trial is testing whether different forms of education and support can help caregivers of cancer patients feel better prepared.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Since this trial focuses on educational interventions rather than medical treatments, there aren't typical medication side effects. However, participants may experience emotional or psychological stress due to the nature of caregiving.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I am undergoing my first round of radiation therapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at baseline, at end of treatment (average of seven weeks), and at 4 and 20 weeks post treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at baseline, at end of treatment (average of seven weeks), and at 4 and 20 weeks post treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline, at end of treatment (average of seven weeks), and at 4 and 20 weeks post treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Anxiety

Secondary outcome measures

CG HRQOL as measured by PROMIS Global Health Scale Global Physical Health and Global Mental Health domains

CG anxiety at 4 weeks post treatment

CG anxiety at the end of radiation treatment

+8 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: InterventionExperimental Treatment2 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 CareActive Control1 Intervention

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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Case Comprehensive Cancer CenterLead Sponsor

452 Previous Clinical Trials

31,730 Total Patients Enrolled

Susan Mazanec, PhDPrincipal InvestigatorUniversity Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Media Library

One-on-one teaching sessions Clinical Trial Eligibility Overview. Trial Name: NCT04055948 — N/A

Cancer Research Study Groups: Control - Standard of Care, Intervention

Cancer Clinical Trial 2023: One-on-one teaching sessions Highlights & Side Effects. Trial Name: NCT04055948 — N/A

One-on-one teaching sessions 2023 Treatment Timeline for Medical Study. Trial Name: NCT04055948 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many research participants are enrolled in this experiment?

"Yes, according to clinicaltrials.gov this study is actively searching for its required 180 participants from a single site. Noteworthy, the trial was first announced on December 17th 2019 and last updated November 14th 2022."

Answered by AI

Is this research endeavor currently seeking participants?

"Affirmative. The clinical trial database at clinicaltrials.gov states that the study, which was initially announced on December 17th 2019, is actively recruiting for 180 participants from a single location."

Answered by AI

Recent research and studies

BMC NursingJournal

Building Family Caregiver Skills Using a Simulation-based Intervention for Care of Patients with Cancer: Protocol for a Randomized Controlled Trial

Mazanec, Susan R., Eric Blackstone, and Barbara J. Daly. 2021. “Building Family Caregiver Skills Using a Simulation-based Intervention for Care of Patients with Cancer: Protocol for a Randomized Controlled Trial”. BMC Nursing. Springer Science and Business Media LLC. doi:10.1186/s12912-021-00612-4.

clinicaltrials.govStudy

Building Family Caregiver Skills Using a Simulation-Based Intervention for Care of Cancer Patients

2019. "Building Family Caregiver Skills Using a Simulation-Based Intervention for Care of Cancer Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04055948.