A Field Test of the Partners in Care Program
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Rate of recruitment
研究概览
简要总结
This trial studies the feasibility of delivering the Partners in Care Program to caregivers of patients with acute myeloid leukemia. Psychological counseling interventions, such as the Partners in Care Program, may help to improve caregivers' psychosocial functioning, marital adjustment in the context of the cancer, communication, and support skills to the patient.
详细描述
OUTLINE: Participants are randomized to 1 of 2 groups.
GROUP A: Participants attend 5 psychoeducational counseling sessions over 30-60 minutes via telephone.
GROUP B: Participants attend 5 psychoeducational counseling sessions over 30-60 minutes via video teleconference.
After completion of study, participants are followed up at 4 months.
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
- Single (Care Provider)
盲法说明
Site intermediary and referring MD
入排标准
- 年龄范围
- 18 Years 至 82 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosis of AML within the recent 2 months
- •Caregivers and patients need to write, read, and speak English as one of their languages of choice; and currently sharing a residence at least 50% of the time together
- •Patient must have no other concurrent cancer diagnosis except for basal or squamous cell
- •Caregiver must be able to sustain up to 60 minutes of interaction with patient educator
- •Ability to understand and the willingness to sign a written informed consent document
排除标准
- •Participants will be excluded if either the patient or the caregiver cannot write, read, and speak English as one of their languages of choice; are not currently sharing a residence at least 50% of the time together
- •The patient cannot have another concurrent cancer diagnosis except for basal or squamous cell
- •Caregiver cannot sustain up to 60 minutes of interaction with the patient educator
- •Caregiver does not have access to a computer with 2-way video capability (i.e. ZOOM) or a cell phone
研究组 & 干预措施
Group A (psychoeducational counseling sessions via telephone)
Participants attend 5 psychoeducational counseling sessions over 30-60 minutes via telephone.
干预措施: Telephone-Based Intervention (Behavioral)
Group A (psychoeducational counseling sessions via telephone)
Participants attend 5 psychoeducational counseling sessions over 30-60 minutes via telephone.
干预措施: Questionnaire Administration (Other)
Group B (psychoeducational counseling sessions in person)
Participants attend 5 psychoeducational counseling sessions over 30-60 minutes via video teleconference.
干预措施: Behavioral, Psychological or Informational Intervention (Other)
Group B (psychoeducational counseling sessions in person)
Participants attend 5 psychoeducational counseling sessions over 30-60 minutes via video teleconference.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Rate of recruitment
时间窗: Up to 1 year
Rate of enrollment
时间窗: Up to 1 year
Rate of completion of 5-session intervention
时间窗: Up to 1 year
次要结局
- Change in standardized measures of caregiver and patients' scores in each group on anxiety (State-Trait Anxiety Inventory [STAI])(Baseline up to 4 months)
- Change in standardized measures of caregiver and patients' scores in each group on depressed mood (Center for Epidemiologic Studies Depression Scale [CES-D])(Baseline up to 4 months)
- Change in standardized measures of caregiver and patients' scores in each group on Spouse Skills Checklist(Baseline up to 4 months)
- Change in standardized measures of caregiver and patients' scores in each group on Cancer Self-efficacy (CASE)(Baseline up to 4 months)