Feasibility of a Dyadic Life Review Intervention for Older Patients With Advanced Cancer and Mild Cognitive Impairment (MCI) and Their Caregivers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Proportion of Dyads That Complete the Study
研究概览
简要总结
The purpose of this study is to test the feasibility of a telehealth Dyadic Life Review (DLR), adapted from individual Life Review Therapy, with patients and caregivers of older adults with advanced cancer, including those with also Mild Cognitive Impairment (MCI). The study will enroll aim to enroll 20 dyads (pairs) of patients and caregivers (40 total subjects).
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to provide informed consent. All patients will be assessed using the University of California, San Diego Brief Assessment of Capacity to Consent (UBACC) 56 - a score >14.5 will define ability to independently provide informed consent.
- •Eligible patients have Stage III or IV cancer of any type
- •Additionally, at least 20 patients will have a will have a high likelihood of MCI based on screening score of <26 on the Montreal Cognitive Assessment (MoCA) within their eRecord chart.
- •Able to read and understand English
排除标准
- •Patients scoring <14.5 on the UBACC
- •Unable to identify caregiver to participate in study
- •Caregiver Inclusion Criteria:
- •One caregiver for each patient will be eligible and must be chosen by the patient. For the purposes of this study, a caregiver is defined as a valued and trusted person in a patient's life who is supportive in health care matters by providing valuable social support and/or direct assistive care.
- •Caregivers will be selected by the patient when asked if there is a "family member, partner, friend or caregiver with whom you discuss or who can be helpful in health-related matters;" patients who cannot identify such a person ("caregiver") will remain eligible for the study.
- •Age 50 or older
- •Ability to provide consent
- •Proficient in English
- •Caregiver Exclusion Criteria
- •Caregivers unable to understand the consent form due to cognitive, health or sensory impairment will be excluded
结局指标
主要结局
Proportion of Dyads That Complete the Study
时间窗: week 14
The number of participants that complete the entire study procedures out of the number of participants enrolled in the study. The study consisted of one patient and one caregiver (defined as a dyad) that completed the study procedures together), therefore there were 19 dyads enrolled in the study or 38 participants. The proportion of participants that completed the study was determined out of the 19 dyads enrolled.
Proportion of Participants That Consent Who Are Approached for the Study
时间窗: Baseline
The number of participants who consented for the study out of the number of eligible participants who were approached and asked if they would like to be in the study. This outcome measures the proportion of potential participants approached who provided informed consent to participate in the Dyadic Life Review (DLR) study. A total of 42 patients were approached, and 38 provided informed consent to participate.The proportion was calculated as the number who consented divided by the total number approached (38 ÷ 42 × 100 = 90.5 percent).
Number of Participants Who State the Intervention is Acceptable During a Qualitative Interview
时间窗: week 14
The proportion of participants who completed the full study intervention and indicated that the intervention was acceptable during post-intervention qualitative interviews. Acceptability was assessed only among participants who completed all study sessions.
次要结局
- Mean Change in the UCLA Loneliness Score for Caregivers(baseline to week 14)
- Mean Change in Unidimensional Relationship Closeness Scale for Caregivers(baseline to week 14)
- Mean Change in Perceived Stress Scale for Caregivers(baseline to week 14)
- Mean Change in Caregiver Reaction Scale for Caregivers(baseline to week 14)
- Mean Change in Geriatric Depression Scale for Caregivers(baseline to week 14)
- Mean Change in Distress Thermometer and Problem List for Caregivers(baseline to week 14)
- Mean Change in Dyadic Adjustment Scale-7 for Caregivers(baseline to week 14)
- Mean Change in Dyadic Support Questionnaire For Caregivers(baseline to week 14)
- Mean Change in the Correlation Between Patient and Caregiver Distress(baseline to week 14)
- Mean Change in PROMIS29 Depression Domain For Caregivers(baseline to week 14)
- Mean Change in PROMIS29 Anxiety Domain For Caregivers(baseline to week 14)
- Mean Change in PROMIS29 Physical Function Domain For Caregivers(baseline to week 14)
- Mean Change in PROMIS29 Pain Interference Domain For Caregivers(baseline to week 14)
- Mean Change in PROMIS29 Fatigue Domain For Caregivers(baseline to week 14)
- Mean Change in PROMIS29 Sleep Disturbance Domain For Caregivers(baseline to week 14)
- Mean Change in PROMIS29 Ability to Participate in Social Roles Domain For Caregivers(baseline to week 14)
研究者
Lee Kehoe
Research Assistant Professor
University of Rochester