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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment COACH-Cog for dementia patients facing cancer decisions?

Research shows that shared decision-making, which involves patients, family members, and healthcare providers, is effective in helping people with dementia communicate their values and choices. This approach is preferred and can improve patient satisfaction and acceptance of treatment decisions. ^{1 2 3 4 5}

How is the COACH-Cog treatment different from other treatments for dementia patients facing cancer decisions?

COACH-Cog is unique because it focuses on enhancing communication between dementia patients, their caregivers, and healthcare providers, which is crucial for making informed cancer treatment decisions. Unlike traditional treatments that may focus on medication, this approach emphasizes improving understanding and cooperation through specialized communication strategies. ^{6 7 8 9 10}

Research Team

Allison Magnuson

Principal Investigator

University of Rochester

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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 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 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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Involving patients with dementia in decisions to initiate treatment: effect on patient acceptance, satisfaction and medication prescription. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Should capacity assessments be performed routinely prior to discussing advance care planning with older people? [2019]

3. United Arab Emirates pubmed.ncbi.nlm.nih.gov

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

4. England pubmed.ncbi.nlm.nih.gov

Study protocol for 'we DECide': implementation of advance care planning for nursing home residents with dementia. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Shared decision-making in persons living with dementia: A scoping review. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Preliminary Evidence for Dementia Collaborative Coaching. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

A proposal for a novel approach to reduce burdens of care for people with dementia: A hypothesis. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Connecting Through Conversation: A Novel Video-Feedback Intervention to Enhance Long-Term Care Aides' Person-Centred Dementia Communication. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Psychometric evaluation of the Holden Communication Scale (HCS) for persons with dementia. [2019]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Improving Communication between Persons with Mild Dementia and Their Caregivers: Qualitative Analysis of a Practice-Based Logopaedic Intervention. [2019]