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

Case Comprehensive Cancer Center (Case CCC) logo

Case Comprehensive Cancer Center (Case CCC)

Status

Completed

Conditions

Head and Neck Cancer

Treatments

Behavioral: In-person education sessions
Other: Survey
Other: Interview
Behavioral: NCI Booklet

Study type

Interventional

Funder types

Other

Identifiers

NCT02577237
CASE2315

Details and patient eligibility

About

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.

Full 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.

Enrollment

18 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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)

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

18 participants in 2 patient groups

Intervention Group: Caregiver education
Experimental group
Description:
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.
Treatment:
Other: Interview
Other: Survey
Behavioral: In-person education sessions
Control Group: educational booklet
Active Comparator group
Description:
The control group will receive an educational booklet about caregiving in addition to usual care by their doctors and nurses
Treatment:
Behavioral: NCI Booklet
Other: Interview
Other: Survey

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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