CancerCOACH-CogNCT06313853
Enhancing Triadic Communication About Cognition for Older Adults With Alzheimer's Disease or Related Dementias Facing a Cancer Management Decision
A study testing COACH-Cog in people with Cancer and Dementia, run by University of Rochester at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 65 years and older
- What is being tested?
- COACH-Cog
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2024to 30 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Rochester Wilmot Cancer Institute
Rochester, New York, 14620
Allison Magnuson, DO, MS, Allison_magnuson@urmc.rochester.edu
Jessica Bauer, JessicaC_Bauer@URMC.Rochester.edu
About this study
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.
- Being tested
- COACH-Cog
- Medical subject headings
- Neoplasms, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COACH-CogBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| COACH-Cog Intervention | Experimental | Oncology clinician intervention components: 1) a brief training video, 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) 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. Receives: Behavioral: COACH-Cog |
| Usual Care | No intervention | Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Care Partner: Health Care Climate Questionnaire (HCCQ)
Care Partner autonomy support; score range: 6-42; higher score is better.
Measured: 4-weeks post oncology clinical encounter
Secondary outcomes (8)
Zarit Caregiver Burden Assessment
4-Item Measure Care partner well-being: Caregiver burden; total score range 0-16; Higher score is worse burden.
Measured: 4-weeks post-oncology clinical encounter and 3-months post-oncology clinical encounter
Horton QOL S-subscale
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.
Measured: 4-weeks post-oncology clinical encounter and 3-months post-oncology clinical encounter
Care Partner PROMIS Depression
Care partner well-being: Depression; score range 4-20; higher score is worse
Measured: 4-weeks post-oncology clinical encounter and 3-months post-oncology clinical encounter
Care partner PROMIS Anxiety
Care partner well-being: Anxiety; score range 4-20; higher score is worse
Measured: 4-weeks post-oncology clinical encounter and 3-months post-oncology clinical encounter
Care partner: Patient-Centered Communication in Cancer Care (PCC-Ca)
Care partner communication; score range 1-5; higher scores are better
Measured: 4-weeks post-oncology clinical encounter and 3-months post-oncology clinical encounter
Care partner: Health Care Climate Questionnaire - Age (HCCQ-Age)
Care partner Age-related autonomy support; score range 0-28; higher scores are worse
Measured: 4-weeks post-oncology clinical encounter and 3-months post-oncology clinical encounter
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
Measured: 3-months post-oncology clinical encounter
Care partner: Decision Regret Scale
Care partner: Decision regret; score range 5-25; higher score is worse
Measured: 3-months post-oncology clinical encounter
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start1 Oct 2024
- Primary completion15 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster-randomized
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Allison Magnuson, University of Rochester
- Investigators
- Allison Magnuson, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06313853
- Sponsor's protocol ID
- STUDY00007374
- Other IDs
- R01AG077053
- Acronym
- COACH-Cog
- Status last verified
- Mar 2026
- First submitted
- 6 Feb 2024
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Triadic Communication About Cognition for Older Adults With Alzheimer's Disease or Related Dementias Facing a Cancer Management Decision
- ClinicalTrials.gov ID
- NCT06313853
- Acronym / sponsor ID
- COACH-Cog / STUDY00007374
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 15 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 15 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Cluster-randomized
| Arm | Type | Receives |
|---|---|---|
| COACH-Cog Intervention | Experimental | Behavioral: COACH-CogOncology clinician intervention components: 1) a brief training video, 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) 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. |
| Usual Care | No intervention | –Usual Care |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COACH-CogOncology 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. | Behavioural | COACH-Cog Intervention |
Primary outcome
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.
8 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
Related trials for Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Allison Magnuson principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing COACH-Cog in people with Cancer and Dementia, run by University of Rochester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Allison Magnuson (585-602-5085, allison_magnuson@urmc.rochester.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Care Partner: Health Care Climate Questionnaire (HCCQ) (time frame: 4-weeks post oncology clinical encounter). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2026.