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

Cancer Clinical Trial

— COACH-Cog  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06313853
• Other study ID #: STUDY00007068
• Status: Recruiting
• Phase: N/A
• Start date: April 22, 2024
• Est. completion date: October 2027

Study information

• Verified date: May 2024
• Source: University of Rochester
• Contact: Allison Magnuson
• Phone: 585-602-5085
• Email: allison_magnuson[@]urmc.rochester.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 305
• Est. completion date: October 2027
• Est. primary completion date: April 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Cancer
• Dementia

Intervention

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.

Locations

Country	Name	City	State
United States	University of Rochester Wilmot Cancer Institute	Rochester	New York

Sponsors (2)

Lead Sponsor	Collaborator
University of Rochester	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	Patient Decision Regret Scale	Patient: Decision regret; score range 5-25; higher score is worse	3-months post-oncology clinical encounter
Other	Physician Decision Regret Scale	Physician: Decision regret; score range 5-25; higher score is worse	3-months post-oncology clinical encounter
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Care partner: Decision Regret Scale	Care partner: Decision regret; score range 5-25; higher score is worse	3-months post-oncology clinical encounter