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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-01

Study Completion Date

2018-01-12

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Head and Neck Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

In-person education sessions

Intervention Type BEHAVIORAL

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.

Survey

Intervention Type OTHER

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

Intervention Type OTHER

A structured series of open-ended questions will be used during a telephone interview with participants at four weeks post radiation treatment.

Control Group: educational booklet

The control group will receive an educational booklet about caregiving in addition to usual care by their doctors and nurses

Group Type ACTIVE_COMPARATOR

NCI Booklet

Intervention Type BEHAVIORAL

Radiation Oncology Nurse will hand participant the NCI booklet

Survey

Intervention Type OTHER

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

Intervention Type OTHER

A structured series of open-ended questions will be used during a telephone interview with participants at four weeks post radiation treatment.

Interventions

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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.

Intervention Type BEHAVIORAL

NCI Booklet

Radiation Oncology Nurse will hand participant the NCI booklet

Intervention Type BEHAVIORAL

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.

Intervention Type OTHER

Interview

A structured series of open-ended questions will be used during a telephone interview with participants at four weeks post radiation treatment.

Intervention Type OTHER

Other Intervention Names

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intervention group educational content/simulation When Someone You Love is being Treated for Cancer semi-structured interview Open ended questions

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes