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

Not Applicable

Recruiting

• Conditions: Cancer; Dementia

• Registration Number: NCT06313853
• Lead Sponsor: University of Rochester

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-06
• Study First Submitted QC: 2024-03-08
• Study First Posted: 2024-03-15
• Study Start: 2024-10-01
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-06
• Last Update Posted: 2025-03-10
• Primary Completion: 2027-04-15
• Study Completion: 2027-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Care Partner: Health Care Climate Questionnaire (HCCQ)	4-weeks post oncology clinical encounter	Care Partner autonomy support; score range: 6-42; higher score is better.

Secondary Outcome Measures

Name	Time	Method
Zarit Caregiver Burden Assessment	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.
Horton QOL S-subscale	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.
Care Partner PROMIS Depression	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
Care partner PROMIS Anxiety	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
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 communication; score range 1-5; higher scores are better
Care partner: Health Care Climate Questionnaire - Age (HCCQ-Age)	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
Care partner: Qualitative assessment of goal concordance	3-months post-oncology clinical encounter	Care partner: Goal concordance; qualitative analysis if goal concordance occurred (yes/no); range 0-130; higher number better
Care partner: Decision Regret Scale	3-months post-oncology clinical encounter	Care partner: Decision regret; score range 5-25; higher score is worse

Trial Locations

Locations (1)

University of Rochester Wilmot Cancer Institute; 🇺🇸 Rochester, New York, United States