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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 65 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06313853
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University of Rochester
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Allison Magnuson
Principal Investigator Affiliation University of Rochester
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other, NIH
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Cancer, Dementia
Arms & Interventions

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

Behavioral: - 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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Rochester, New York

Status

Recruiting

Address

University of Rochester Wilmot Cancer Institute

Rochester, New York, 14620

Site Contact

Allison Magnuson, DO, MS

[email protected]

585-602-5085

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