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Trial Title:
Enhancing Triadic Communication About Cognition for Older Adults With Alzheimer's Disease or Related Dementias Facing a Cancer Management Decision
NCT ID:
NCT06313853
Condition:
Cancer
Dementia
Conditions: Official terms:
Alzheimer Disease
Dementia
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Cluster-randomized
Primary purpose:
Supportive Care
Masking:
Single (Outcomes Assessor)
Intervention:
Intervention type:
Behavioral
Intervention name:
COACH-Cog
Description:
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.
Arm group label:
COACH-Cog Intervention
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.
Criteria for eligibility:
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
Gender:
All
Minimum age:
65 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Rochester Wilmot Cancer Institute
Address:
City:
Rochester
Zip:
14620
Country:
United States
Status:
Recruiting
Contact:
Last name:
Allison Magnuson, DO, MS
Email:
Allison_magnuson@urmc.rochester.edu
Contact backup:
Last name:
Jessica Bauer
Email:
JessicaC_Bauer@URMC.Rochester.edu
Start date:
April 22, 2024
Completion date:
October 2027
Lead sponsor:
Agency:
University of Rochester
Agency class:
Other
Collaborator:
Agency:
National Institute on Aging (NIA)
Agency class:
NIH
Source:
University of Rochester
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06313853