Recruiting

COACH-Cog

Sponsor:

University of Rochester

Code:

NCT06313853

Conditions

Cancer

Dementia

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Interventions

COACH-Cog

Study Details

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 ID

NCT06313853

Start date

Oct 1, 2024

Status verified date

Mar, 2026

Completion date

Apr 30, 2027

Anticipated

Primary completion date

Apr 15, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: 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.

no intervention: Usual Care

Usual Care

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.

Primary outcome measure

  • Care Partner: Health Care Climate Questionnaire (HCCQ) [ Time Frame: 4-weeks post oncology clinical encounter ]

Central Contacts and Locations

Central contacts

Allison Magnuson

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

Jessica Bauer

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

Locations

University of Rochester Wilmot Cancer Institute

Recruiting

Rochester, New York, United States, 14620

Contacts

Allison Magnuson, DO, MS

Allison_magnuson@urmc.rochester.edu

Jessica Bauer

JessicaC_Bauer@URMC.Rochester.edu

More Information

Sponsor

University of Rochester

Last update posted

Mar 24, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Rochester on 2026-03-24.