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

NCT ID: NCT06313853

Last Updated: 2025-03-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-01
• Study Completion Date: 2027-04-30

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.

Conditions

Cancer; Dementia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

COACH-Cog Intervention

Oncology clinician intervention components: 1) a brief training video, 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) 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.

Group Type: EXPERIMENTAL

COACH-Cog

Intervention Type: BEHAVIORAL

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.

Usual Care

Usual Care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

1. Age 18 or over

2. Able to read and understand spoken English

3. Able to provide informed consent

1. Oncology clinicians affiliated with the Wilmot Cancer Institute

2. Do not intend to move or retire within the next 2 years.

Exclusion Criteria

CARE PARTNER:

None

ONCOLOGY CLINICIAN:

None

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

University of Rochester

OTHER

Sponsor Role: lead

Responsible Party

Allison Magnuson

Associate Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Allison Magnuson

Role: PRINCIPAL_INVESTIGATOR

University of Rochester

Locations

University of Rochester Wilmot Cancer Institute

Rochester, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Allison Magnuson

Role: CONTACT

allison_magnuson@urmc.rochester.edu

585-602-5085

Jessica Bauer

Role: CONTACT

JessicaC_Bauer@URMC.Rochester.edu

585-602-5085

Facility Contacts

Allison Magnuson, DO, MS

Role: primary

Allison_magnuson@urmc.rochester.edu

Jessica Bauer

Role: backup

JessicaC_Bauer@URMC.Rochester.edu

Other Identifiers

R01AG077053

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00007068

Identifier Type: -

Identifier Source: org_study_id