跳至主要内容
临床试验/NCT06313853
NCT06313853招募中不适用

Enhancing Triadic Communication About Cognition for Older Adults With Alzheimer's Disease or Related Dementias Facing a Cancer Management Decision

University of Rochester1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2024年10月1日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Allison Magnuson

Associate Professor of Medicine

University of Rochester

研究点 (1)

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