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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06313853
Acronym
COACH-Cog
Enrollment
300
Registered
2024-03-15
Start date
2024-10-01
Completion date
2027-04-30
Last updated
2026-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer, Dementia

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.

Interventions

BEHAVIORALCOACH-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.

Sponsors

University of Rochester
Lead SponsorOTHER
National Institute on Aging (NIA)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)

Intervention model description

Cluster-randomized

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
Care Partner: Health Care Climate Questionnaire (HCCQ)4-weeks post oncology clinical encounterCare Partner autonomy support; score range: 6-42; higher score is better.

Secondary

MeasureTime frameDescription
Zarit Caregiver Burden Assessment4-weeks post-oncology clinical encounter and 3-months post-oncology clinical encounter4-Item Measure Care partner well-being: Caregiver burden; total score range 0-16; Higher score is worse burden.
Horton QOL S-subscale4-weeks post-oncology clinical encounter and 3-months post-oncology clinical encounter11-Item Measure (Subscale Measure) of Care partner well-being: Quality of Life; Total score range 0-11; higher score is worse quality of life.
Care Partner PROMIS Depression4-weeks post-oncology clinical encounter and 3-months post-oncology clinical encounterCare partner well-being: Depression; score range 4-20; higher score is worse
Care partner PROMIS Anxiety4-weeks post-oncology clinical encounter and 3-months post-oncology clinical encounterCare partner well-being: Anxiety; score range 4-20; higher score is worse
Care partner: Patient-Centered Communication in Cancer Care (PCC-Ca)4-weeks post-oncology clinical encounter and 3-months post-oncology clinical encounterCare partner communication; score range 1-5; higher scores are better
Care partner: Health Care Climate Questionnaire - Age (HCCQ-Age)4-weeks post-oncology clinical encounter and 3-months post-oncology clinical encounterCare partner Age-related autonomy support; score range 0-28; higher scores are worse
Care partner: Qualitative assessment of goal concordance3-months post-oncology clinical encounterCare partner: Goal concordance; qualitative analysis if goal concordance occurred (yes/no); range 0-130; higher number better
Care partner: Decision Regret Scale3-months post-oncology clinical encounterCare partner: Decision regret; score range 5-25; higher score is worse

Countries

United States

Contacts

CONTACTAllison Magnuson
allison_magnuson@urmc.rochester.edu585-602-5085
CONTACTJessica Bauer
JessicaC_Bauer@URMC.Rochester.edu585-602-5085
PRINCIPAL_INVESTIGATORAllison Magnuson

University of Rochester

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 30, 2026