Clinical trial · Interventional
Building Family Caregiver Skills Using a Simulation-Based Intervention for Care of Cancer Patients
Building Family Caregiver Skills Using a Simulation-Based Intervention for Care of Patients With Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| One-on-one support/educational sessions | Behavioral | — | UNRESOLVED |
| Telephone booster contact | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Control - Standard of Care
- description
- CG(caregivers)/CP(cancer patients) dyads
- type
- EXPERIMENTAL
- label
- Intervention
- description
- 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.
- interventionNames
- Behavioral: One-on-one support/educational sessions
- Behavioral: Telephone booster contact
Primary outcomes (1)
- measure
- CG Anxiety at 20 Weeks Post-treatment
- timeFrame
- 20 weeks post treatment
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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).
References
Publications (2)
- DERIVEDPark 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
- DERIVEDMazanec 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