N/A
N=484
Building Family Caregiver Skills Using a Simulation-Based Intervention for Care of Cancer Patients
Cancer
Bottom Line
View on ClinicalTrials.gov: NCT04055948 ↗Enrolled (actual)
484
Serious AEs
0.0%
Results posted
Mar 2026
Primary outcome: Primary: CG Anxiety at 20 Weeks Post-treatment — 52.3; 51.6 T-score
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- One-on-one support/educational sessions (Behavioral); Telephone booster contact (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Case Comprehensive Cancer Center
- Primary completion
- Feb 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY CG Anxiety at 20 Weeks Post-treatment |
52.3; 51.6 | — |
| SECONDARY CG Anxiety at Baseline |
53.2; 53.2 | — |
| SECONDARY CG Anxiety at the End of Radiation Treatment |
53.4; 53.2 | — |
| SECONDARY CG Anxiety at 4 Weeks Post Treatment |
52.9; 52.3 | — |
| SECONDARY CG Depression |
49.7; 49.6; 50.2; 50.6; 50.7; 49.6 | — |
| SECONDARY CG Health-related Quality of Life (HRQOL) as Measured by PROMIS Global Health Scale - Global Mental Health Domain |
50.6; 50.2; 46.8; 46.7; 47.5; 47.6 | — |
| SECONDARY CG HRQOL as Measured by PROMIS Global Health Scale - Global Physical Health |
51.6; 51; 49; 49.9; 49.6; 50.7 | — |
| SECONDARY CG Fatigue |
48.8; 49; 51.3; 49.3; 51.1; 48 | — |
| SECONDARY Participant HRQOL (Cancer Patient) as Measured by FACT-G |
76.5; 79.3; 69.7; 70.6; 74.6; 74.4 | — |
| SECONDARY Interrupted Treatment |
0; 0 | — |
| SECONDARY Healthcare Utilization for Participants, as Measured by Number of Hospital Admissions |
0; 0 | — |
| SECONDARY Healthcare Utilization for Participants, as Measured by Number of Emergency Room Visits |
0; 0 | — |
| SECONDARY Healthcare Utilization for Participants, as Measured by Number of Visits for IV Hydration |
0; 0 | — |
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.
Eligibility Criteria
Inclusion Criteria (for patients):
- 18 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.
Inclusion Criteria (for CGs):
- 18 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.
Exclusion Criteria
- 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).
Data sourced from ClinicalTrials.gov (NCT04055948). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.