Clinical trial NCT02577237: Building Caregiver Skills Using a Simulation-based Intervention for Care of Head and Neck Cancer
Official title: Building Family Caregiver Skills Using a Simulation-based Intervention for Care of Patients With Head and Neck Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Head and Neck Cancer
Keywords: caregiver
simulation
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2015-10-16
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Patients with head and neck 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 tests whether different forms of education and support can help family caregivers feel better prepared. To find out if education about caregiving and different kinds of support are effective, this study wants to compare approaches.One group includes caregivers who will receive an education and support program throughout radiation treatment in addition to usual care by their doctors and nurses. The other group receives an educational booklet about caregiving in addition to usual care by their doctors and nurses. The caregiver also completes surveys about his or her emotions, distress, confidence as a care giver, and quality of life. In addition, the study asks the caregiver questions about his or her age, race, ethnicity, marital status, employment status, education, annual household income, and current living arrangements. This pilot study will only be offered at the Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center Main Campus.

Detailed description: Aim 1: Conduct a pilot test of the effects of a novel caregiver intervention, as compared to a control group, on family caregiver self-efficacy for caregiving, anxiety, depression, and health-related quality of life.

Aim 2: Explore the acceptability of a caregiver intervention that utilizes simulation.

Aim 3: Assess the feasibility of the intervention. Aim 4: Describe the incidence of patient events that may be impacted by caregiver self-efficacy, such as acute care visits, admissions to the hospital, visits to the emergency department, need for fluids in the radiation oncology department, and interrupted treatment course.

Eligibility criteria: Inclusion Criteria:

* family member or friend of an adult patient with a new diagnosis of Stage III - IV cancers of the tongue, gum, oral cavity, nasopharynx, oropharynx, hypopharynx, larynx, or parotid who is receiving radiation therapy for curative intent
* identified by the patient as his/her primary caregiver who is providing daily assistance and/or emotional support
* cognitively intact, as evidenced by orientation to person, place, and time
* ability to speak, read, and comprehend English

Exclusion Criteria:

* Caregivers 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
* Caregivers who are themselves undergoing active cancer treatment will be excluded (hormonal treatment allowed)

Primary outcomes:
measure: Average efficacy of caregiving summary score
timeFrame: Up to 5 weeks
measure: Average anxiety summary score
timeFrame: Up to 5 weeks
measure: Average depression summary score
timeFrame: Up to 5 weeks
measure: Average Health Related Quality of Life (HRQOL) summary score
timeFrame: Up to 5 weeks
Secondary outcomes:
measure: Qualitative assessment of acceptability
timeFrame: Up to 5 weeks
measure: Attrition rate to assess feasibility
timeFrame: Up to 5 weeks
measure: Consent rate to assess feasibility
timeFrame: Up to 5 weeks
measure: Total time for delivering intervention to assess costs
timeFrame: Up to 5 weeks
measure: Average missed checklist items to assess integrity of intervention
timeFrame: Up to 5 weeks
measure: Event rate for patient events
timeFrame: Up to 5 weeks
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
name: Susan Mazanec, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References: