A Patient-Caregiver Behavioral Intervention for Older Adults With Cancer and Mild Cognitive Impairment-2
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Number of completed sessions as measured by enrollment log
研究概览
简要总结
The purpose of this study is to see whether programs that include both a patient and their spouse or a patient and family caregiver (known as a dyad) are helpful for families in which one member of the dyad has cancer and mild memory difficulties and/or concerns. Participant and their spouse or participant and their family caregiver will have six, 60-minute video-conference sessions which will be scheduled at their convenience. The investigator will loan participants a tablet computer (iPad) to use for videoconferencing and train the participant in its use. Participant and their spouse or participant and their family caregiver will complete three assessments - one before starting the sessions, one after the sixth session, and one after 1 month. Each assessment will include surveys, which the participant will complete separately from their spouse or family caregiver. For most people, it will take upwards of 2 - 4 months to complete this study
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient inclusion criteria include:
- •Patients with Stage I-IV breast, gastrointestinal (GI), genitourinary (GU), or lung cancer (including extensive stage small cell lung cancer), diagnosed within two years; age 65 or older.
- •Participants must be living at home (either in her/his own home).
- •Participants must be fluent in English and able to learn basic skills for using a tablet computer to conduct videoconference treatment sessions.
- •Exhibit Mild Cognitive Impairment/Concerns
- •Have an informal family caregiver.
- •Inclusion Criteria:
- •(Partner or family member) inclusion criteria include:
- •Caregivers are 18 older.
- •Be fluent in English and able to learn basic skills for using a tablet computer to conduct videoconference treatment sessions.
- •Either co-reside with the patient or spend at least 3-4 hours day caregiving.
- •Not exhibit cognitive impairment.
排除标准
- •Participant has visual or hearing impairments that preclude participation.
- •Participant has dementia and do not have the capacity to participate.
- •Have a serious untreated psychiatric illness as documented in medical chart review.
- •The patient and the caregiver score less than a 3 on the National Comprehensive Cancer Network (NCCN) Distress Thermometer (DT) on a scale 0 to 10 to screen for distress. At least one dyad member must experience distress.
研究组 & 干预措施
Patient Caregiver Dyad
Participants who are 65 years or older with cancer and mild cognitive impairment with their caregiver.
干预措施: Behavioral: COPE + (Behavioral)
结局指标
主要结局
Number of completed sessions as measured by enrollment log
时间窗: Up to 17 Weeks
Number of participants who are satisfied with the intervention as measured by a score of 24 or greater on the CSQ-8
时间窗: Up to 17 weeks
The Client Satisfaction Questionnaire (CSQ-8) is a self report measure of satisfaction with health and behavioral services received. The CSQ-8 is measured on a four point Likert scale from 1 "Quite Dissatisfied" to 4 "Very Satisfied." Scores range from 8-32, with higher values indicating higher satisfaction
次要结局
- Change in Distress as measured by the DASS-21(Baseline, up to 17 weeks, up to 1 month follow up)
- Change in Quality of Life as measured by the FACT-G(Baseline, up to 17 weeks, up to 1 month follow up)
- Change in Communication Patterns as measured by the CPQ-SF(Baseline, up to 17 weeks, up to 1 month follow up)
- Change in Relationship Satisfaction as measured by the Mutuality Scale of the Family Care Inventory(Baseline, up to 17 weeks, up to 1 month follow up)