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

March 19, 2026 updated by: Allison Magnuson, University of Rochester
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Usual Care
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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Care Partner: Health Care Climate Questionnaire (HCCQ)
Time Frame: 4-weeks post oncology clinical encounter
Care Partner autonomy support; score range: 6-42; higher score is better.
4-weeks post oncology clinical encounter

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Care Partner PROMIS Depression
Time Frame: 4-weeks post-oncology clinical encounter and 3-months post-oncology clinical encounter
Care partner well-being: Depression; score range 4-20; higher score is worse
4-weeks post-oncology clinical encounter and 3-months post-oncology clinical encounter
Care partner PROMIS Anxiety
Time Frame: 4-weeks post-oncology clinical encounter and 3-months post-oncology clinical encounter
Care partner well-being: Anxiety; score range 4-20; higher score is worse
4-weeks post-oncology clinical encounter and 3-months post-oncology clinical encounter
Care partner: Patient-Centered Communication in Cancer Care (PCC-Ca)
Time Frame: 4-weeks post-oncology clinical encounter and 3-months post-oncology clinical encounter
Care partner communication; score range 1-5; higher scores are better
4-weeks post-oncology clinical encounter and 3-months post-oncology clinical encounter
Care partner: Health Care Climate Questionnaire - Age (HCCQ-Age)
Time Frame: 4-weeks post-oncology clinical encounter and 3-months post-oncology clinical encounter
Care partner Age-related autonomy support; score range 0-28; higher scores are worse
4-weeks post-oncology clinical encounter and 3-months post-oncology clinical encounter
Care partner: Qualitative assessment of goal concordance
Time Frame: 3-months post-oncology clinical encounter
Care partner: Goal concordance; qualitative analysis if goal concordance occurred (yes/no); range 0-130; higher number better
3-months post-oncology clinical encounter
Care partner: Decision Regret Scale
Time Frame: 3-months post-oncology clinical encounter
Care partner: Decision regret; score range 5-25; higher score is worse
3-months post-oncology clinical encounter
Zarit Caregiver Burden Assessment
Time Frame: 4-weeks post-oncology clinical encounter and 3-months post-oncology clinical encounter
4-Item Measure Care partner well-being: Caregiver burden; total score range 0-16; Higher score is worse burden.
4-weeks post-oncology clinical encounter and 3-months post-oncology clinical encounter
Horton QOL S-subscale
Time Frame: 4-weeks post-oncology clinical encounter and 3-months post-oncology clinical encounter
11-Item Measure (Subscale Measure) of Care partner well-being: Quality of Life; Total score range 0-11; higher score is worse quality of life.
4-weeks post-oncology clinical encounter and 3-months post-oncology clinical encounter

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Patient: Patient-Centered Communication in Cancer Care (PCC-Ca)
Time Frame: 4-weeks post-oncology clinical encounter and 3-months post-oncology clinical encounter
Patient communication; score range 1-5; higher scores are better
4-weeks post-oncology clinical encounter and 3-months post-oncology clinical encounter
Patient: Health Care Climate Questionnaire (HCCQ)
Time Frame: 4-weeks post-oncology clinical encounter and 3-months post-oncology clinical encounter
Patient autonomy support; score range: 6-42; higher score is better.
4-weeks post-oncology clinical encounter and 3-months post-oncology clinical encounter
Patient: Health Care Climate Questionnaire - Age (HCCQ-Age)
Time Frame: 4-weeks post-oncology clinical encounter and 3-months post-oncology clinical encounter
Patient Age-related autonomy support; score range 0-28; higher scores are worse
4-weeks post-oncology clinical encounter and 3-months post-oncology clinical encounter
Patient Decision Regret Scale
Time Frame: 3-months post-oncology clinical encounter
Patient: Decision regret; score range 5-25; higher score is worse
3-months post-oncology clinical encounter
Physician Decision Regret Scale
Time Frame: 3-months post-oncology clinical encounter
Physician: Decision regret; score range 5-25; higher score is worse
3-months post-oncology clinical encounter

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Rochester

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Aging (NIA)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Allison Magnuson, University of Rochester

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 15, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 6, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 8, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 15, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 24, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 19, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY00007374
  • R01AG077053 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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