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

NCT ID: NCT06313853

Condition: Cancer
Dementia

Conditions: Official terms:
Alzheimer Disease
Dementia

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Intervention model description: Cluster-randomized

Primary purpose: Supportive Care

Masking: Single (Outcomes Assessor)

Intervention:

Intervention type: Behavioral
Intervention name: COACH-Cog
Description: 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 if able) will participate in a one-time communication coaching session; 2) Patient GA results with management recommendations to consider discussing with the oncology team will be provided to care partners and patients.
Arm group label: COACH-Cog Intervention

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.

Criteria for 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

Gender: All

Minimum age: 65 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: University of Rochester Wilmot Cancer Institute

Address:
City: Rochester
Zip: 14620
Country: United States

Status: Recruiting

Contact:
Last name: Allison Magnuson, DO, MS
Email: Allison_magnuson@urmc.rochester.edu

Contact backup:
Last name: Jessica Bauer
Email: JessicaC_Bauer@URMC.Rochester.edu

Start date: April 22, 2024

Completion date: October 2027

Lead sponsor:
Agency: University of Rochester
Agency class: Other

Collaborator:
Agency: National Institute on Aging (NIA)
Agency class: NIH

Source: University of Rochester

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06313853

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