Enhancing Triadic Communication About Cognition for Older Adults With Alzheimer's Disease or Related Dementias Facing a Cancer Management Decision
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Care Partner: Health Care Climate Questionnaire (HCCQ)
研究概览
简要总结
Building upon prior work, the investigator team developed a communication intervention for older adults with ADRD who are considering a decision about cancer management (adapted intervention: COACH-Cog). The investigators hypothesize that for patients with dual diagnoses of ADRD and cancer, COACH-Cog will increase autonomy support of care partners and patients in the decision-making process, leading to greater acknowledgement and support of cognitive concerns and cognitive-related goals, thereby improving goal concordant care. The investigators are conducting a pilot randomized controlled trial (RCT; cluster randomized by physician) including approximately 45 oncology clinicians and 130 patient/care partner dyads evaluating the effect of COACH-Cog on care partner and patient autonomy support, care partner well-being, goal-concordance, and communication.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient Inclusion Criteria:
- •Be age 65 or older
- •Have a clinical diagnosis of Alzheimer's disease or related dementia (ADRD [Alzheimer's disease, vascular dementia, Lewy body dementia, frontotemporal dementia, or dementia of unknown subtype])
- •Have a clinical diagnosis of cancer (any type or stage)
- •Anticipate a potential decision about cancer-related management, as confirmed by the patient's primary medical oncology clinician.
- •Have a care partner willing and able to participate in the study
- •Are able to read and understand English. The communication coaching session will be delivered in English, thus necessitating this requirement.
- •Be able to provide informed consent (as measured by UBACC) or have a Legally Authorized Representative to provide informed consent
排除标准
- •Patient exclusion criteria: None
- •CARE PARTNER:
- •Care partner inclusion criteria:
- •Age 18 or over
- •Able to read and understand spoken English
- •Able to provide informed consent
- •Care partner exclusion criteria:
- •ONCOLOGY CLINICIAN:
- •Oncology clinician inclusion criteria:
- •Oncology clinicians affiliated with the Wilmot Cancer Institute
- •Do not intend to move or retire within the next 2 years.
- •Oncology clinician exclusion criteria:
结局指标
主要结局
Care Partner: Health Care Climate Questionnaire (HCCQ)
时间窗: 4-weeks post oncology clinical encounter
Care Partner autonomy support; score range: 6-42; higher score is better.
次要结局
- Zarit Caregiver Burden Assessment(4-weeks post-oncology clinical encounter and 3-months post-oncology clinical encounter)
- Horton QOL S-subscale(4-weeks post-oncology clinical encounter and 3-months post-oncology clinical encounter)
- Care Partner PROMIS Depression(4-weeks post-oncology clinical encounter and 3-months post-oncology clinical encounter)
- Care partner PROMIS Anxiety(4-weeks post-oncology clinical encounter and 3-months post-oncology clinical encounter)
- Care partner: Patient-Centered Communication in Cancer Care (PCC-Ca)(4-weeks post-oncology clinical encounter and 3-months post-oncology clinical encounter)
- Care partner: Health Care Climate Questionnaire - Age (HCCQ-Age)(4-weeks post-oncology clinical encounter and 3-months post-oncology clinical encounter)
- Care partner: Qualitative assessment of goal concordance(3-months post-oncology clinical encounter)
- Care partner: Decision Regret Scale(3-months post-oncology clinical encounter)
研究者
Allison Magnuson
Associate Professor of Medicine
University of Rochester