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

NCT06313853 | Recruiting DMC

• 2 other identifiers: STUDY00007374R01AG077053
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Care Partner: Health Care Climate Questionnaire (HCCQ)

  Care Partner autonomy support; score range: 6-42; higher score is better.

  4-weeks post oncology clinical encounter

Secondary Outcomes (8)

• 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

Other Outcomes (5)

• Patient: Patient-Centered Communication in Cancer Care (PCC-Ca)

  4-weeks post-oncology clinical encounter and 3-months post-oncology clinical encounter

• Patient: Health Care Climate Questionnaire (HCCQ)

  4-weeks post-oncology clinical encounter and 3-months post-oncology clinical encounter

• Patient: Health Care Climate Questionnaire - Age (HCCQ-Age)

  4-weeks post-oncology clinical encounter and 3-months post-oncology clinical encounter

Study Arms (2)

COACH-Cog Intervention

EXPERIMENTAL

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.

Behavioral: COACH-Cog

Usual Care

NO INTERVENTION

Usual Care

Interventions

COACH-Cog 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.

COACH-Cog Intervention

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• CARE PARTNER:
• Age 18 or over
• Able to read and understand spoken English
• Able to provide informed consent
• None
• ONCOLOGY CLINICIAN:
• Oncology clinicians affiliated with the Wilmot Cancer Institute
• Do not intend to move or retire within the next 2 years.
• None

Sponsors & Collaborators

• University of Rochester: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of Rochester Wilmot Cancer Institute

Rochester, New York, 14620, United States

RECRUITING

MeSH Terms

Conditions

Neoplasms; Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Allison Magnuson

  University of Rochester

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Allison Magnuson

CONTACT

585-602-5085; allison_magnuson@urmc.rochester.edu

Jessica Bauer

CONTACT

585-602-5085; JessicaC_Bauer@URMC.Rochester.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Model Details: Cluster-randomized

Study Record Dates

• First Submitted: February 6, 2024
• First Posted: March 15, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): April 15, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: March 24, 2026

Record last verified: 2026-03

Locations

US (1)