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

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: Not yet recruiting
• Conditions: Cancer; Dementia
• Intervention / Treatment: Behavioral: COACH-Cog

• Study Type: Interventional
• Enrollment (Estimated): 305
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Allison Magnuson; Phone Number: 585-602-5085; Email: allison_magnuson@urmc.rochester.edu
• Study Contact Backup: Name: Jessica Bauer; Phone Number: 585-602-5085; Email: JessicaC_Bauer@URMC.Rochester.edu

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14620
      • University of Rochester Wilmot Cancer Institute
      • Contact: Allison Magnuson, DO, MS; Email: Allison_magnuson@urmc.rochester.edu
      • Contact: Jessica Bauer; Email: JessicaC_Bauer@URMC.Rochester.edu

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Montgomery Borgatta Caregiving Burden Scale	Care partner well-being: Caregiver burden; total score range 14-70; range for subscales 4-30; higher score is better for Objective Subscale; Higher score is worse for Subjective Stress and Subjective Demand subscales	4-weeks post-oncology clinical encounter and 3-months post-oncology clinical encounter
World Health Organization Quality of Life Brief Version (WHOQOL-BREF)	Care partner well-being: Quality of Life; Total score range 26-130; domain range 3-40; higher score is better	4-weeks post-oncology clinical encounter and 3-months post-oncology clinical encounter
Care Partner PROMIS Depression	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	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)	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)	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	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	Care partner: Decision regret; score range 5-25; higher score is worse	3-months post-oncology clinical encounter

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient: Patient-Centered Communication in Cancer Care (PCC-Ca)	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)	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)	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	Patient: Decision regret; score range 5-25; higher score is worse	3-months post-oncology clinical encounter
Physician Decision Regret Scale	Physician: Decision regret; score range 5-25; higher score is worse	3-months post-oncology clinical encounter

Collaborators and Investigators

• Sponsor: University of Rochester
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Allison Magnuson, University of Rochester

Study record dates

Study Major Dates

• Study Start (Estimated): March 15, 2024
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: February 6, 2024
• First Submitted That Met QC Criteria: March 8, 2024
• First Posted (Actual): March 15, 2024

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 8, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Tauopathies; Dementia; Alzheimer Disease
• Other Study ID Numbers: STUDY00007068

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No