COACH-Cog for Dementia Patients Facing Cancer Decisions

(COACH-Cog Trial)

Overseen By Allison Magnuson

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: University of Rochester

Disqualifiers: None

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach called COACH-Cog to assist individuals with both dementia and cancer in making better decisions about their cancer care. The goal is to enhance communication among patients, their care partners, and doctors, ensuring that everyone's goals and concerns are understood and considered. The trial compares usual care to the COACH-Cog intervention, which includes brief training for doctors and a communication coaching session for patients and their care partners. Suitable participants are those aged 65 or older with dementia and cancer, who are facing decisions about cancer treatment and have a care partner willing to participate. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could improve decision-making and communication in cancer care.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the COACH-Cog intervention is safe for dementia patients facing cancer decisions?

Research shows that COACH-Cog is a tool designed to assist patients with Alzheimer's Disease or Related Dementias (ADRD) in making cancer treatment decisions. It aims to enhance communication among patients, their caregivers, and doctors. The tool includes training for cancer doctors and coaching sessions for patients and their caregivers.

Since COACH-Cog focuses on improving communication rather than being a drug or medical procedure, physical side effects are not a concern. Instead, the emphasis is on how effectively people can use and benefit from the communication tips provided. In past studies, similar tools have been used safely, with no reports of harm.

However, it's important to note that this project is still in the early stages of testing for cancer-related decisions. This means there might not be extensive data yet on its effectiveness or any potential issues in this specific area. Prospective participants should consider discussing any concerns with the research team. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the COACH-Cog intervention because it offers a tailored approach for dementia patients who need to make cancer-related decisions. Unlike typical care, which often lacks specific guidance for these patients, COACH-Cog includes a brief training video for oncology clinicians and provides personalized recommendations based on a patient's geriatric assessment. This helps both patients and their care partners communicate more effectively with healthcare providers, potentially leading to better-informed decisions and improved management of both dementia and cancer.

What evidence suggests that the COACH-Cog intervention is effective for improving decision-making in dementia patients facing cancer decisions?

Research has shown that the COACH-Cog program, available to participants in this trial, might assist older adults with Alzheimer's or similar conditions in making better cancer treatment decisions. Studies suggest this tool enhances communication among patients, caregivers, and doctors. By addressing memory and thinking issues, COACH-Cog aims to empower patients to make their own care decisions. Early findings indicate that caregivers feel more recognized and supported, potentially leading to care that aligns more closely with patients' wishes. Although further research is ongoing, these early results are promising for improving care in this challenging situation. ^{1 2 4 5 6}

Who Is on the Research Team?

Allison Magnuson

Principal Investigator

University of Rochester

Are You a Good Fit for This Trial?

This trial is for older adults with Alzheimer's Disease or related dementias (ADRD) who also have to make decisions about cancer treatment. They need a care partner involved in the decision-making process. Specific eligibility details are not provided, but typically participants must meet certain health and cognitive criteria.

Inclusion Criteria

Oncology clinicians must not intend to move or retire within the next 2 years

Patients must have a care partner willing and able to participate in the study

I have been diagnosed with cancer.

Exclusion Criteria

Not applicable.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive the COACH-Cog communication intervention, including a communication coaching session and management recommendations based on GA results.

4 weeks

1 visit (in-person) for coaching session

Follow-up

Participants are monitored for autonomy support, care partner well-being, and communication effectiveness.

3 months

2 visits (virtual) at 4 weeks and 3 months post-oncology clinical encounter

What Are the Treatments Tested in This Trial?

Interventions

• COACH-Cog

Trial Overview The study tests COACH-Cog, a communication aid designed to help patients with ADRD and their care partners make informed decisions about cancer treatments. The goal is to support autonomy and ensure that treatment choices align with the patient's values and preferences.

How Is the Trial Designed?

Group I: COACH-Cog Intervention Experimental Treatment 1 Intervention

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.

Group II: Usual Care Active Control 1 Intervention

Usual Care

COACH-Cog is already approved in United States for the following indications:

Approved in United States as COACH-Cog for:

• Improving communication and autonomy support for older adults with Alzheimer's Disease or Related Dementias facing cancer management decisions

Who Is Running the Clinical Trial?

University of Rochester

Lead Sponsor

Trials

883

Recruited

555,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Published Research Related to This Trial

The Dementia Collaborative Coaching intervention significantly improved certified nursing assistants' (CNAs) self-perceived knowledge and efficacy in using external memory aids, with a notable increase in scores from pre-intervention to post-intervention.

People living with dementia (PLWD) experienced a significant reduction in agitation, as measured by the Cohen-Mansfield Agitation Inventory, indicating that the intervention may effectively support communication and reduce behavioral issues in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary Evidence for Dementia Collaborative Coaching. Douglas, NF., Browning, S., Claypool, K.[2023]

The digital communication platform (DCP) used in the study led to reduced agitation and a decrease in the use of psychotropic medications among nursing home dementia patients, suggesting it can improve patient care.

The Cooperation with Care Scale-Revised (CWCS-R) was found to be a reliable and valid tool for measuring cooperation with care in dementia patients, which could enhance communication strategies and overall quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A proposal for a novel approach to reduce burdens of care for people with dementia: A hypothesis. Varshney, SU., Varshney, U., McCall, WV.[2022]

A pilot study involving 11 care aide-resident pairs demonstrated that a video-feedback communication intervention significantly improved person-centred dementia communication skills, particularly in linguistic reciprocity and continuity.

Care aides reported increased confidence, competence, and relationship closeness with residents after the intervention, suggesting that this approach could enhance the quality of care in dementia settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Connecting Through Conversation: A Novel Video-Feedback Intervention to Enhance Long-Term Care Aides' Person-Centred Dementia Communication. O'Rourke, DJ., Lobchuk, MM., Thompson, GN., et al.[2022]

The 'we DECide' educational intervention for nursing home staff aims to improve shared decision-making in advance care planning for residents with dementia, focusing on key moments such as admission and crisis situations.

This study, conducted in 19 nursing homes in Belgium, hypothesizes that better training will enhance the quality of end-of-life care and promote more person-centered approaches for residents with dementia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study protocol for 'we DECide': implementation of advance care planning for nursing home residents with dementia. Ampe, S., Sevenants, A., Coppens, E., et al.[2019]

The online dementia prevention intervention, particularly the cognitive behavioral shared decision-making model (CBSDM), was positively received by participants aged 40 and older, indicating good acceptability for promoting brain health.

While there were no significant differences in primary outcome measures between the CBSDM group and the treatment-as-usual group, participants in the CBSDM group reported increased knowledge about dementia risk factors and exercise, suggesting potential benefits in behavior change strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Online Shared Decision-making Intervention for Dementia Prevention: A Parallel-group Randomized Pilot Study. Ownby, RL., Davenport, R.[2023]

In a study of 32 older adults with a mean age of 84.1, over half (53.1%) were found to lack the capacity to engage in advanced care planning (ACP), particularly struggling with understanding the concept of ACP.

The Advance Care Planning-Capacity Assessment Vignette tool (ACP-CAV) was accurate in assessing capacity in 68.8% of cases compared to the MacCAT-T, indicating that while it can be useful, clinicians should ensure thorough understanding and consider further assessment when needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Should capacity assessments be performed routinely prior to discussing advance care planning with older people? Kiriaev, O., Chacko, E., Jurgens, JD., et al.[2019]

Older adults with cognitive impairment, including those living with dementia, can effectively communicate their values and preferences, highlighting the importance of shared decision-making involving patients, families, and healthcare providers.

The review identified 32 studies that emphasize the need for tailored decision-making approaches in healthcare, suggesting that shared decision-making is preferred and requires intentional effort, with a focus on health promotion and advanced care planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Shared decision-making in persons living with dementia: A scoping review. Mattos, MK., Gibson, JS., Wilson, D., et al.[2023]

The Holden Communication Scale (HCS) is a reliable and valid tool for assessing communication abilities in individuals with moderate to severe cognitive impairment, showing high internal consistency (Cronbach's α = 0.94) and good test-retest reliability (r = 0.71).

There is a moderate correlation between communication ability (measured by HCS) and cognitive function (measured by MMSE) in individuals with very low cognitive scores (MMSE 0-10), while the correlation is low for those with slightly better cognitive function (MMSE 11-20), indicating that communication ability may significantly decline as cognitive impairment worsens.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychometric evaluation of the Holden Communication Scale (HCS) for persons with dementia. Strøm, BS., Engedal, K., Šaltytė Benth, J., et al.[2019]

In a study analyzing 71 video-recorded dementia diagnostic meetings, doctors primarily used suggestions (42%) and proposals (25%) when discussing medication, but over 80% of patients showed some form of resistance to starting medication, often through passive means.

Despite the high level of patient resistance and low satisfaction with direct pronouncements about medication, doctors continued to prescribe medication, indicating that factors beyond patient preference influenced prescribing decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Involving patients with dementia in decisions to initiate treatment: effect on patient acceptance, satisfaction and medication prescription. Dooley, J., Bass, N., Livingston, G., et al.[2021]

The newly developed logopaedic intervention, consisting of 6 one-hour sessions with 4 dyads of persons with dementia and their caregivers, identified five key elements that enhance communication, including interactive history taking and the use of communication tools.

Participants reported improved interaction and self-confidence due to the supportive approach of the speech-language therapist, suggesting that this home-based intervention could effectively reduce stress and frustration in daily communication for those affected by dementia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving Communication between Persons with Mild Dementia and Their Caregivers: Qualitative Analysis of a Practice-Based Logopaedic Intervention. Olthof-Nefkens, MWLJ., Kruse, H., Derksen, E., et al.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06313853

Enhancing Triadic Communication About Cognition for ... Enhancing Triadic Communication About Cognition for Older Adults With Alzheimer's Disease or Related Dementias Facing a Cancer Management Decision (COACH-Cog).

2. reporter.nih.gov reporter.nih.gov/search/I_bJWIRR_0Kb3TKRVha0zw/project-details/11077266

Project Details - NIH RePORTER Adapting this tool for patients with ADRD (adapted tool called “COACH-Cog”) may improve both care partner and patient outcomes through greater acknowledgement ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05775991

COACH-Cog Intervention Adaptation Focus Groups To gather key stakeholder input for feedback on the adaption of the COACH GA intervention (i.e., develop COACH-Cog) to enhance triadic communication among ...

4. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/91/NCT05775991/Prot_SAP_000.pdf

Enhancing Triadic Communication About Cognition for ... COACH-Cog adaptations will include: 1) brief, focused training for oncology clinicians about dementia in the context of cancer and communication ...

5. alz-journals.onlinelibrary.wiley.com alz-journals.onlinelibrary.wiley.com/doi/10.1002/alz.14200?af=R

Applying recommendations for diagnostic disclosure of mild ... A comprehensive evaluation for cognitive impairment should culminate with the communication of the diagnosis to patients and their care ...

6. reporter.nih.gov reporter.nih.gov/project-details/11177680

Improving Biopsychosocial Outcomes of Older Adults ... Enhancing Triadic Communication About Cognition for Older Adults with Alzheimer's Disease or Related Dementias Facing a Cancer Management Decision. 545 ...