Building Caregiver Skills Using a Simulation-based Intervention for Care of Head and Neck Cancer

Head and Neck Cancer Clinical Trial

Official title:

Building Family Caregiver Skills Using a Simulation-based Intervention for Care of Patients With Head and Neck Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02577237
• Other study ID #: CASE2315
• Status: Completed
• Phase: N/A
• Start date: August 1, 2015
• Est. completion date: January 12, 2018

Study information

• Verified date: February 2019
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: January 12, 2018
• Est. primary completion date: January 12, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Behavioral:
• In-person education sessions
The intervention will be delivered by a radiation oncology nurse. Each of the four in-person sessions consists of approximately 30 minutes of educational content/simulation that addresses a specific caregiving topic and any issues or concerns that the caregiver may be experiencing.
• NCI Booklet
Radiation Oncology Nurse will hand participant the NCI booklet

Other:
• Survey
written, qualitative assessments of areas including depression and anxiety, caregiver self-efficacy, care-giver self efficacy for head and neck cancer, health-related quality of life, patient performance status, demographics, and medical history.
• Interview
A structured series of open-ended questions will be used during a telephone interview with participants at four weeks post radiation treatment.

Locations

Country	Name	City	State
United States	University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average efficacy of caregiving summary score	Summary statistics as well as observed values of longitudinally measured efficacy outcome variables (efficacy for caregiving, anxiety, depression, and HRQOL) will be presented graphically. Linear mixed models will be used to estimate within- and between-subject components of variance needed for design of a larger trial with these endpoints.	Up to 5 weeks
Primary	Average anxiety summary score	Summary statistics as well as observed values of longitudinally measured efficacy outcome variables (efficacy for caregiving, anxiety, depression, and HRQOL) will be presented graphically. Linear mixed models will be used to estimate within- and between-subject components of variance needed for design of a larger trial with these endpoints.	Up to 5 weeks
Primary	Average depression summary score	Summary statistics as well as observed values of longitudinally measured efficacy outcome variables (efficacy for caregiving, anxiety, depression, and HRQOL) will be presented graphically. Linear mixed models will be used to estimate within- and between-subject components of variance needed for design of a larger trial with these endpoints.	Up to 5 weeks
Primary	Average Health Related Quality of Life (HRQOL) summary score	Summary statistics as well as observed values of longitudinally measured efficacy outcome variables (efficacy for caregiving, anxiety, depression, and HRQOL) will be presented graphically. Linear mixed models will be used to estimate within- and between-subject components of variance needed for design of a larger trial with these endpoints.	Up to 5 weeks
Secondary	Qualitative assessment of acceptability	Descriptive statistics will be used to summarize responses to semi-structured interviews	Up to 5 weeks
Secondary	Attrition rate to assess feasibility	Feasibility will be assessed via attrition and consent rates.	Up to 5 weeks
Secondary	Consent rate to assess feasibility	Feasibility will be assessed via attrition and consent rates.	Up to 5 weeks
Secondary	Total time for delivering intervention to assess costs	Time for delivering the intervention will be recorded to aid in assessing costs.	Up to 5 weeks
Secondary	Average missed checklist items to assess integrity of intervention	Integrity of the intervention will be assessed through monitoring of intervention checklist.	Up to 5 weeks
Secondary	Event rate for patient events	Describe the average incidence of all patient events that may be impacted by caregiver self-efficacy. Events may include acute care visits, admission to the hospital, visits to the emergency department, need for fluids in the radiation oncology department, and interrupted treatment course, and others	Up to 5 weeks