Skip to main content
OpenTrials
Completed

NCT Number: NCT02577237

Building Caregiver Skills Using a Simulation-based Intervention for Care of 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Head and Neck Cancer Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

In-person education sessions

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.

Other names: intervention group, educational content/simulation

NCI Booklet

Behavioral

Radiation Oncology Nurse will hand participant the NCI booklet

Other names: When Someone You Love is being Treated for Cancer

Survey

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

Other

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Case Comprehensive Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Oct 16, 2015
Registry last updated
Feb 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.