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

Обзор

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.

Вмешательства

• Поведенческое COACH-Cog
  Oncology clinician intervention components: 1) a brief training video (completed once during the duration of the study following enrollment and randomization), 2) For each patient/care partner dyad that is subsequently enrolled onto the study that the clinician cares for, the oncology clinician will receive the results of the patient's GA with targeted management recommendations for identified GA domain impairments Patient/Care partner dyad intervention components: 1) Care partners (and patients

Первичные конечные точки

• Care Partner: Health Care Climate Questionnaire (HCCQ) [Срок оценки: 4-weeks post oncology clinical encounter]

Вторичные конечные точки (8)

• Zarit Caregiver Burden Assessment [Срок оценки: 4-weeks post-oncology clinical encounter and 3-months post-oncology clinical encounter]
• Horton QOL S-subscale [Срок оценки: 4-weeks post-oncology clinical encounter and 3-months post-oncology clinical encounter]
• Care Partner PROMIS Depression [Срок оценки: 4-weeks post-oncology clinical encounter and 3-months post-oncology clinical encounter]
• Care partner PROMIS Anxiety [Срок оценки: 4-weeks post-oncology clinical encounter and 3-months post-oncology clinical encounter]
• Care partner: Patient-Centered Communication in Cancer Care (PCC-Ca) [Срок оценки: 4-weeks post-oncology clinical encounter and 3-months post-oncology clinical encounter]
• Care partner: Health Care Climate Questionnaire - Age (HCCQ-Age) [Срок оценки: 4-weeks post-oncology clinical encounter and 3-months post-oncology clinical encounter]
• Care partner: Qualitative assessment of goal concordance [Срок оценки: 3-months post-oncology clinical encounter]
• Care partner: Decision Regret Scale [Срок оценки: 3-months post-oncology clinical encounter]

Критерии участия

PATIENTS:

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

Patient Exclusion Criteria:

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:

None

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:

None

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• University of Rochester Wilmot Cancer Institute — Rochester

Идентификаторы

NCT: NCT06313853 · STUDY00007374 · R01AG077053

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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