Clinical trial NCT06313853: Enhancing Triadic Communication About Cognition for Older Adults With Alzheimer's Disease or Related Dementias Facing a Cancer Management Decision
Official title: Enhancing Triadic Communication About Cognition for Older Adults With Alzheimer's Disease or Related Dementias Facing a Cancer Management Decision
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer
Dementia
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2024-03-15
Enrollment: 300
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster-randomized
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: PATIENTS:

Patient Inclusion Criteria:

1. Be age 65 or older
2. Have a clinical diagnosis of Alzheimer's disease or related dementia (ADRD \[Alzheimer's disease, vascular dementia, Lewy body dementia, frontotemporal dementia, or dementia of unknown subtype\])
3. Have a clinical diagnosis of cancer (any type or stage)
4. Anticipate a potential decision about cancer-related management, as confirmed by the patient's primary medical oncology clinician.
5. Have a care partner willing and able to participate in the study
6. Are able to read and understand English. The communication coaching session will be delivered in English, thus necessitating this requirement.
7. 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:

1. Age 18 or over
2. Able to read and understand spoken English
3. Able to provide informed consent

Care partner exclusion criteria:

None

ONCOLOGY CLINICIAN:

Oncology clinician inclusion criteria:

1. Oncology clinicians affiliated with the Wilmot Cancer Institute
2. Do not intend to move or retire within the next 2 years.

Oncology clinician exclusion criteria:

None

Primary outcomes:
measure: Care Partner: Health Care Climate Questionnaire (HCCQ)
timeFrame: 4-weeks post oncology clinical encounter
Secondary outcomes:
measure: Zarit Caregiver Burden Assessment
timeFrame: 4-weeks post-oncology clinical encounter and 3-months post-oncology clinical encounter
measure: Horton QOL S-subscale
timeFrame: 4-weeks post-oncology clinical encounter and 3-months post-oncology clinical encounter
measure: Care Partner PROMIS Depression
timeFrame: 4-weeks post-oncology clinical encounter and 3-months post-oncology clinical encounter
measure: Care partner PROMIS Anxiety
timeFrame: 4-weeks post-oncology clinical encounter and 3-months post-oncology clinical encounter
measure: Care partner: Patient-Centered Communication in Cancer Care (PCC-Ca)
timeFrame: 4-weeks post-oncology clinical encounter and 3-months post-oncology clinical encounter
measure: Care partner: Health Care Climate Questionnaire - Age (HCCQ-Age)
timeFrame: 4-weeks post-oncology clinical encounter and 3-months post-oncology clinical encounter
measure: Care partner: Qualitative assessment of goal concordance
timeFrame: 3-months post-oncology clinical encounter
measure: Care partner: Decision Regret Scale
timeFrame: 3-months post-oncology clinical encounter
Other outcomes:
measure: Patient: Patient-Centered Communication in Cancer Care (PCC-Ca)
timeFrame: 4-weeks post-oncology clinical encounter and 3-months post-oncology clinical encounter
measure: Patient: Health Care Climate Questionnaire (HCCQ)
timeFrame: 4-weeks post-oncology clinical encounter and 3-months post-oncology clinical encounter
measure: Patient: Health Care Climate Questionnaire - Age (HCCQ-Age)
timeFrame: 4-weeks post-oncology clinical encounter and 3-months post-oncology clinical encounter
measure: Patient Decision Regret Scale
timeFrame: 3-months post-oncology clinical encounter
measure: Physician Decision Regret Scale
timeFrame: 3-months post-oncology clinical encounter
Locations:
city: Rochester
country: United States
facility: University of Rochester Wilmot Cancer Institute
state: New York
Study officials:
affiliation: University of Rochester
name: Allison Magnuson
role: PRINCIPAL_INVESTIGATOR
References: