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

NCT04055948 | Completed Results

• 2 other identifiers: CASE4Y191R37CA240707-01
• Study Type: interventional
• Target: 484
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

• CG Anxiety at 20 Weeks Post-treatment

  Difference in CG anxiety between the intervention and control groups at 20 weeks post-radiation treatment. CG anxiety will be measured with the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Short Form 7a. This 7-item questionnaire assesses self-reported fear, worry, anxiety, tension, nervousness, and restlessness in the family caregiver over the last 7 days. This outcome will be reporting the average T-score for anxiety as measured by the PROMIS scale. Raw scores range from 7 to 35. Each participant's raw score on the scale will be converted to a standardized T-score that has a mean of 50 and a standard deviation of 10. A higher T-score represents greater anxiety. For example, a T-score of 60 is one standard deviation worse anxiety than average.

  20 weeks post treatment

Secondary Outcomes (12)

• CG Anxiety at Baseline

  Baseline

• CG Anxiety at the End of Radiation Treatment

  At end of treatment, average of seven weeks

• CG Anxiety at 4 Weeks Post Treatment

  4 weeks post treatment

• CG Depression

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

• CG Health-related Quality of Life (HRQOL) as Measured by PROMIS Global Health Scale - Global Mental Health Domain

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

Study Arms (2)

Control - Standard of Care

NO INTERVENTION

CG(caregivers)/CP(cancer patients) dyads

Intervention

EXPERIMENTAL

CG/CP dyads * Three, one-on-one support/educational sessions with the caregiver during radiation treatment, followed by a telephone booster contact 2 weeks post-treatment.

Behavioral: One-on-one support/educational sessions; Behavioral: Telephone booster contact

Interventions

One-on-one support/educational sessions BEHAVIORAL

One-on-one support/educational sessions with the caregiver during radiation treatments (note - intervention sessions 2 \& 3 delivered by phone during COVID-19 and remained an option after the pandemic).

Intervention

Telephone booster contact BEHAVIORAL

Telephone booster contact 2 weeks post-treatment.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older.
• Diagnosis of stage I, II, III cancers of the rectum and anus, stage I, II, III, IVa esophagus; stage II-III NSCLC (excluding those receiving SBRT due to short treatment course); and stage I - IV A/B head/neck (tongue, gum, oral cavity, nasopharynx, oropharynx, hypopharynx, parotid, or larynx). Stage IV A/B will be allowed for HNC and stage IVa for esophagus as the intent of therapy is curative.
• Has an identified family CG who is willing to participate.
• years of age or older
• Family member or friend of an adult patient described above
• Identified by the patient as his/her primary CG, who is providing daily assistance and/or emotional support.

You may not qualify if:

• Patients who do not have a caregiver will be excluded.
• 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.
• CGs who are themselves undergoing active cancer treatment will be excluded (hormonal treatment allowed).

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

Location

Related Publications (2)

• Park S, Blackstone EC, Mazanec SR. Exploring the determinants of health literacy and its effects on health-related outcomes in family caregivers of patients with cancer. Support Care Cancer. 2025 Apr 29;33(5):433. doi: 10.1007/s00520-025-09494-7.

  PMID: 40299112 DERIVED

• Mazanec SR, Blackstone E, Daly BJ. Building family caregiver skills using a simulation-based intervention for care of patients with cancer: protocol for a randomized controlled trial. BMC Nurs. 2021 Jun 9;20(1):93. doi: 10.1186/s12912-021-00612-4.

  PMID: 34107914 DERIVED

MeSH Terms

Conditions

Neoplasms

Results Point of Contact

• Title: Susan Mazanec, PhD, RN, Study Principal Investigator
• Organization: Case Western Reserve University

susan.mazanec@case.edu

1-216-368-5533

Study Officials

• Susan Mazanec, PhD, RN

  Case Western Reserve University, Case Comprehensive Cancer Center, University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Research Assistant (RA) will be blind to which group CG is assigned.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patient and family caregiver dyads are enrolled in this 2-group, prospective, randomized controlled design to test the effect of a caregiver intervention during radiation therapy. The study enrolled a total of 484 participants(242 dyads)

Study Record Dates

• First Submitted: August 7, 2019
• First Posted: August 14, 2019
• Study Start: December 17, 2019
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2025
• Last Updated: March 30, 2026
• Results First Posted: March 9, 2026

Record last verified: 2026-03

Locations

US (2)