Skip to main content
Clinical Trials/NCT06313853
NCT06313853RecruitingNot Applicable

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

University of Rochester1 site in 1 country300 target enrollmentStarted: October 1, 2024Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
300
Locations
1
Primary Endpoint
Care Partner: Health Care Climate Questionnaire (HCCQ)

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Double (Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
65 Years to — (Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Patient Inclusion Criteria:
  • Be age 65 or older
  • 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])
  • Have a clinical diagnosis of cancer (any type or stage)
  • Anticipate a potential decision about cancer-related management, as confirmed by the patient's primary medical oncology clinician.
  • Have a care partner willing and able to participate in the study
  • Are able to read and understand English. The communication coaching session will be delivered in English, thus necessitating this requirement.
  • Be able to provide informed consent (as measured by UBACC) or have a Legally Authorized Representative to provide informed consent

Exclusion Criteria

  • Patient exclusion criteria: None
  • CARE PARTNER:
  • Care partner inclusion criteria:
  • Age 18 or over
  • Able to read and understand spoken English
  • Able to provide informed consent
  • Care partner exclusion criteria:
  • ONCOLOGY CLINICIAN:
  • Oncology clinician inclusion criteria:
  • Oncology clinicians affiliated with the Wilmot Cancer Institute
  • Do not intend to move or retire within the next 2 years.
  • Oncology clinician exclusion criteria:

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Zarit Caregiver Burden Assessment(4-weeks post-oncology clinical encounter and 3-months post-oncology clinical encounter)
  • Horton QOL S-subscale(4-weeks post-oncology clinical encounter and 3-months post-oncology clinical encounter)
  • Care Partner PROMIS Depression(4-weeks post-oncology clinical encounter and 3-months post-oncology clinical encounter)
  • Care partner PROMIS Anxiety(4-weeks post-oncology clinical encounter and 3-months post-oncology clinical encounter)
  • Care partner: Patient-Centered Communication in Cancer Care (PCC-Ca)(4-weeks post-oncology clinical encounter and 3-months post-oncology clinical encounter)
  • Care partner: Health Care Climate Questionnaire - Age (HCCQ-Age)(4-weeks post-oncology clinical encounter and 3-months post-oncology clinical encounter)
  • Care partner: Qualitative assessment of goal concordance(3-months post-oncology clinical encounter)
  • Care partner: Decision Regret Scale(3-months post-oncology clinical encounter)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Allison Magnuson

Associate Professor of Medicine

University of Rochester

Study Sites (1)

Loading locations...

Similar Trials