Enhancing Triadic Communication About Cognition for Older Adults With Alzheimer's Disease or Related Dementias Facing a Cancer Management Decision
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: COACH-Cog.
- Who it may be relevant to
- Registry conditions: Cancer, Dementia. Basic parameters: from 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- 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
Primary outcome measures
- Care Partner: Health Care Climate Questionnaire (HCCQ) [Time frame: 4-weeks post oncology clinical encounter]
Secondary outcome measures (8)
- Zarit Caregiver Burden Assessment [Time frame: 4-weeks post-oncology clinical encounter and 3-months post-oncology clinical encounter]
- Horton QOL S-subscale [Time frame: 4-weeks post-oncology clinical encounter and 3-months post-oncology clinical encounter]
- Care Partner PROMIS Depression [Time frame: 4-weeks post-oncology clinical encounter and 3-months post-oncology clinical encounter]
- Care partner PROMIS Anxiety [Time frame: 4-weeks post-oncology clinical encounter and 3-months post-oncology clinical encounter]
- Care partner: Patient-Centered Communication in Cancer Care (PCC-Ca) [Time frame: 4-weeks post-oncology clinical encounter and 3-months post-oncology clinical encounter]
- Care partner: Health Care Climate Questionnaire - Age (HCCQ-Age) [Time frame: 4-weeks post-oncology clinical encounter and 3-months post-oncology clinical encounter]
- Care partner: Qualitative assessment of goal concordance [Time frame: 3-months post-oncology clinical encounter]
- Care partner: Decision Regret Scale [Time frame: 3-months post-oncology clinical encounter]
Eligibility criteria
PATIENTS:
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
Patient 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:
None
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:
None
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- University of Rochester Wilmot Cancer Institute — Rochester
Identifiers
NCT: NCT06313853 · STUDY00007374 · R01AG077053