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

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

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.

Study Overview

• Status: Completed
• Conditions: Head and Neck Cancer
• Intervention / Treatment: Behavioral: In-person education sessions; Other: Survey; Other: Interview; Behavioral: NCI Booklet

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.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group: Caregiver education; The intervention includes caregivers who will receive an education and support program throughout radiation treatment in addition to usual care by their doctors and nurses.	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.; Other Names: intervention group; educational content/simulation; 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.; Other: Interview; A structured series of open-ended questions will be used during a telephone interview with participants at four weeks post radiation treatment.; Other Names: semi-structured interview; Open ended questions
Active Comparator: Control Group: educational booklet; The control group will receive an educational booklet about caregiving in addition to usual care by their doctors and nurses	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.; Other: Interview; A structured series of open-ended questions will be used during a telephone interview with participants at four weeks post radiation treatment.; Other Names: semi-structured interview; Open ended questions; Behavioral: NCI Booklet; Radiation Oncology Nurse will hand participant the NCI booklet; Other Names: When Someone You Love is being Treated for Cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Qualitative assessment of acceptability	Descriptive statistics will be used to summarize responses to semi-structured interviews	Up to 5 weeks
Attrition rate to assess feasibility	Feasibility will be assessed via attrition and consent rates.	Up to 5 weeks
Consent rate to assess feasibility	Feasibility will be assessed via attrition and consent rates.	Up to 5 weeks
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
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
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

Collaborators and Investigators

• Sponsor: Case Comprehensive Cancer Center
• Investigators: Principal Investigator: Susan Mazanec, PhD, RN, University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2015
• Primary Completion (Actual): January 12, 2018
• Study Completion (Actual): January 12, 2018

Study Registration Dates

• First Submitted: October 14, 2015
• First Submitted That Met QC Criteria: October 14, 2015
• First Posted (Estimate): October 16, 2015

Study Record Updates

• Last Update Posted (Actual): February 11, 2019
• Last Update Submitted That Met QC Criteria: February 8, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: simulation; caregiver
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms
• Other Study ID Numbers: CASE2315

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No