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NCT Number: NCT06313853

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

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.

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Key information

Conditions

Cancer Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Neoplasms Nervous System Diseases Neurocognitive Disorders

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Rochester Wilmot Cancer Institute

Rochester, New York, 14620, United States

Location status: Recruiting

Location contact

Allison Magnuson, DO, MS

CONTACT

[email protected]

Jessica Bauer

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

COACH-Cog

Behavioral

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.

Primary outcomes

  1. 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

  1. Zarit Caregiver Burden Assessment

    Time frame: 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.

  2. Horton QOL S-subscale

    Time frame: 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.

  3. Care Partner PROMIS Depression

    Time frame: 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

  4. Care partner PROMIS Anxiety

    Time frame: 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

  5. 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 communication; score range 1-5; higher scores are better

  6. 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 Age-related autonomy support; score range 0-28; higher scores are worse

  7. Care partner: Qualitative assessment of goal concordance

    Time frame: 3-months post-oncology clinical encounter

    Care partner: Goal concordance; qualitative analysis if goal concordance occurred (yes/no); range 0-130; higher number better

  8. Care partner: Decision Regret Scale

    Time frame: 3-months post-oncology clinical encounter

    Care partner: Decision regret; score range 5-25; higher score is worse

Other outcomes

  1. Patient: Patient-Centered Communication in Cancer Care (PCC-Ca)

    Time frame: 4-weeks post-oncology clinical encounter and 3-months post-oncology clinical encounter

    Patient communication; score range 1-5; higher scores are better

  2. Patient: Health Care Climate Questionnaire (HCCQ)

    Time frame: 4-weeks post-oncology clinical encounter and 3-months post-oncology clinical encounter

    Patient autonomy support; score range: 6-42; higher score is better.

  3. Patient: Health Care Climate Questionnaire - Age (HCCQ-Age)

    Time frame: 4-weeks post-oncology clinical encounter and 3-months post-oncology clinical encounter

    Patient Age-related autonomy support; score range 0-28; higher scores are worse

  4. Patient Decision Regret Scale

    Time frame: 3-months post-oncology clinical encounter

    Patient: Decision regret; score range 5-25; higher score is worse

  5. Physician Decision Regret Scale

    Time frame: 3-months post-oncology clinical encounter

    Physician: Decision regret; score range 5-25; higher score is worse

Study contacts

Contact information is provided by the study sponsor or research team.

Allison Magnuson

CONTACT

[email protected]

585-602-5085

Jessica Bauer

CONTACT

[email protected]

585-602-5085

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Acronym: COACH-Cog

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Mar 15, 2024
Registry last updated
Mar 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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