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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02577237
Recruitment Status : Completed
First Posted : October 16, 2015
Last Update Posted : February 11, 2019
Sponsor:
Information provided by (Responsible Party):
Case Comprehensive Cancer Center

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.

Condition or disease Intervention/treatment Phase
Head and Neck Cancer Behavioral: In-person education sessions Behavioral: NCI Booklet Other: Survey Other: Interview Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Building Family Caregiver Skills Using a Simulation-based Intervention for Care of Patients With Head and Neck Cancer
Actual Study Start Date : August 1, 2015
Actual Primary Completion Date : January 12, 2018
Actual Study Completion Date : January 12, 2018

Resource links provided by the National Library of Medicine


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
Behavioral: NCI Booklet
Radiation Oncology Nurse will hand participant the NCI booklet
Other Name: When Someone You Love is being Treated for Cancer

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




Primary Outcome Measures :
  1. Average efficacy of caregiving summary score [ Time Frame: Up to 5 weeks ]
    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.

  2. Average anxiety summary score [ Time Frame: Up to 5 weeks ]
    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.

  3. Average depression summary score [ Time Frame: Up to 5 weeks ]
    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.

  4. Average Health Related Quality of Life (HRQOL) summary score [ Time Frame: Up to 5 weeks ]
    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.


Secondary Outcome Measures :
  1. Qualitative assessment of acceptability [ Time Frame: Up to 5 weeks ]
    Descriptive statistics will be used to summarize responses to semi-structured interviews

  2. Attrition rate to assess feasibility [ Time Frame: Up to 5 weeks ]
    Feasibility will be assessed via attrition and consent rates.

  3. Consent rate to assess feasibility [ Time Frame: Up to 5 weeks ]
    Feasibility will be assessed via attrition and consent rates.

  4. Total time for delivering intervention to assess costs [ Time Frame: Up to 5 weeks ]
    Time for delivering the intervention will be recorded to aid in assessing costs.

  5. Average missed checklist items to assess integrity of intervention [ Time Frame: Up to 5 weeks ]
    Integrity of the intervention will be assessed through monitoring of intervention checklist.

  6. Event rate for patient events [ Time Frame: Up to 5 weeks ]
    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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02577237


Locations
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United States, Ohio
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
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Principal Investigator: Susan Mazanec, PhD, RN University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
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Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT02577237    
Other Study ID Numbers: CASE2315
First Posted: October 16, 2015    Key Record Dates
Last Update Posted: February 11, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Case Comprehensive Cancer Center:
caregiver
simulation
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms by Site
Neoplasms