Building Family Caregiver Skills Using a Simulation-based Intervention for Care of Patients With Head and Neck Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Average efficacy of caregiving summary score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
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.
干预措施: In-person education sessions (Behavioral)
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.
干预措施: Survey (Other)
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.
干预措施: Interview (Other)
Control Group: educational booklet
The control group will receive an educational booklet about caregiving in addition to usual care by their doctors and nurses
干预措施: NCI Booklet (Behavioral)
Control Group: educational booklet
The control group will receive an educational booklet about caregiving in addition to usual care by their doctors and nurses
干预措施: Survey (Other)
Control Group: educational booklet
The control group will receive an educational booklet about caregiving in addition to usual care by their doctors and nurses
干预措施: Interview (Other)
结局指标
主要结局
Average efficacy of caregiving summary score
时间窗: 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.
Average Health Related Quality of Life (HRQOL) summary score
时间窗: 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.
Average depression summary score
时间窗: 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.
Average anxiety summary score
时间窗: 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.
次要结局
- Consent rate to assess feasibility(Up to 5 weeks)
- Total time for delivering intervention to assess costs(Up to 5 weeks)
- Attrition rate to assess feasibility(Up to 5 weeks)
- Average missed checklist items to assess integrity of intervention(Up to 5 weeks)
- Qualitative assessment of acceptability(Up to 5 weeks)
- Event rate for patient events(Up to 5 weeks)