Trial Title:
Integrated Actionable Aging Assessment for Cancer Patients Pilot
NCT ID:
NCT05871008
Condition:
Breast Cancer
Hodgkin Lymphoma
Kidney Cancer
Leukemia
Lymphoid Leukemia
Multiple Myeloma
Myeloid Leukemia
Monocytic Leukemia
Prostate Cancer
Bladder Cancer
Conditions: Official terms:
Leukemia
Multiple Myeloma
Kidney Neoplasms
Leukemia, Lymphoid
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Health Services Research
Masking:
Single (Participant)
Intervention:
Intervention type:
Other
Intervention name:
Assessment tool IA3-CP with SDoH
Description:
Each patient randomly assigned to IA3-CP with SDoH study arm will complete a pre-visit
assessment tool including SDoH. Feedback is provided to provider and patient.
Arm group label:
IA3-CP with SDoH
Intervention type:
Other
Intervention name:
Assessment tool IA3-CP without SDoH
Description:
Each patient randomly assigned to IA3-CP only study arm will complete a pre-visit
assessment tool excluding SDoH. Feedback is provided to provider and patient.
Arm group label:
IA3-CP only
Summary:
Aging is the greatest risk factor for cancer incidence and mortality. Geriatric screening
is recommended to help with treatment discussions, inform intensity of treatment, and
identify supportive care needs. Despite a strong evidence base, geriatric assessments are
not implemented routinely in oncologic clinics. Similarly, important information on
social determinants of health, mental health, and health behaviors are inconsistently
assessed, and almost never in an integrated fashion. In an effort to support clinicians
delivering the recommended goal-concordant care, the investigators will integrate
assessment of geriatric issues, health behaviors, mental health, and social determinants
of health into an efficient, actionable contextual assessment system for older cancer
patients called Integrated Aging Assessment for Action for Cancer Patients (IA3-CP). The
investigators will use D&I strategies including co-creation engagement approaches and
form-function methods to develop workflow processes that feasibly integrate the IA3-CP
into usual initial assessment with the oncology team. Our objective is to develop and
conduct a randomized pilot of the IA3-CP system and hypothesize that our results will
show it can be implemented consistently, acted on, improve quality of care, and enhance
patient-provider interactions.
Detailed description:
Aging is the greatest risk factor for cancer incidence and mortality. Strong data and
expert recommendations support the use of geriatric screening assessments to guide
treatment for older adults (>65 years old). Geriatric assessment findings can help in
treatment discussions, inform intensity of treatment, and identify supportive care needs.
Yet, despite evidenced-based benefits, geriatric assessments are not implemented
routinely in oncologic clinics. Similarly, there are strong data and expert
recommendations for assessment of social determinants of health (SDoH) and health
behaviors, but consistent assessment and action on SDoH and health behaviors is
infrequent. Clinicians aiming to deliver recommended goal-concordant care to older
patients - which is informed by a patient's frailty, SDoH, health behaviors, and mental
health - must act without this important contextual information.
We have identified a pragmatic geriatric screening tool (the G8) and adapted it to a
validated patient-reported measure. We aim to integrate the novel, validated, patient
reported G8 with the NCI funded, theory driven, evidence-based My Own Health Report
(MOHR) system that captures patient reported health behavior, mental health, and social
determinants of health (SDoH) through a web-based portal. We will integrate assessment of
geriatric issues, health behaviors, mental health, and SDoH into an efficient, actionable
contextual assessment system for older cancer patients called Integrated Aging Assessment
for Action for Cancer Patients (IA3-CP). We will use D&I strategies including co-creation
engagement approaches and form-function methods to develop workflow processes that
feasibly integrate the IA3-CP into usual initial assessment with the oncology team. Our
objective is to develop and conduct a randomized pilot of the IA3-CP system to determine
if it can be implemented consistently, acted on, improve quality of care, and enhance
patient-provider interactions.
RATIONALE:
The phrase "you have cancer" lands differently with older patients than it does those
younger. The issues of frailty, comorbidity, mental and behavioral health, and SDoH are
critical to formulating a personalized cancer treatment approach with an older person as
they can't put these conditions "on hold" to focus on a cancer diagnosis. Aging is the
greatest risk factor for cancer incidence and mortality, with nearly half of all cancers
diagnosed after age 65. There is a clear need to create patient-centered care plans that
align care that is medically feasible and aligned with individual patient needs,
environment, and preferences.
Geriatric screening and assessment is broadly recommended for the care of older persons
with cancer. Similarly, there is strong consensus that SDoH (e.g., food scarcity, medical
affordability, safe environments) and health behaviors are key drivers of health
disparities. Validated, pragmatic patient-report measures of geriatric issues, health
behaviors, and SDoH exist but are seldom consistently assessed in clinical practice,
hardly ever in an integrated fashion, and even less seldom acted on. Clinics need
efficient, cost-effective tools to screen for and address multiple risks at the same time
- technology can provide important efficiencies.
SIGNIFICANCE:
Using age as a primary determinant for cancer treatment puts older adults at risk of
under- or over-treatment of cancer. Failure to implement available tools that enhance our
ability to tailor care planning to the unique needs of older adults represents a critical
gap in patient-centered care.
Implementation of geriatric-specific measures: Oncologists recognize functional
assessment as a predictor of future morbidity and mortality risk, so much so that it
largely dictates oncology treatment selection, yet are using measures insensitive in an
older population. Oncologists will often use clinical gestalt to recommend modified
variants of standard treatment. An integrated assessment system can provide actionable,
more comprehensive personalized data to the patient and care team.
Geriatric 8: The G8 is a brief geriatric assessment tool that has been broadly validated
in the oncology setting to screen for potential frailty and need for a comprehensive
assessment. It incorporates functional status, cognition and mental health, and
nutritional feedback to form a clinic collected 8-item assessment. To address identified
barriers to implementation, the investigators adapted the G8 with input from our Rural
Cancer Advisory Board to a patient-reported version. The investigators then pilot tested
implementation and validity of the modified G8 in seven clinical environments - primary
care and oncology in community and academic settings with excellent results. In parallel,
the investigators devised a way to integrate the patient-reported items into the UCHealth
EHR for use in clinical care and documentation. The investigators now propose to use
similar strategies to integrate the IA3-CP into the EHR.
My Own Health Report (MOHR): MOHR is a patient-centered, web-based health risk assessment
and feedback system for unhealthy behaviors, mental health status, and prioritizing
patient concerns. MOHR has been used successfully in numerous primary care environments
and its use has been found to result in patients feeling more cared for by their clinical
team. Our randomized trial found that patients receiving MOHR improved physical activity
(p < 0.001) and dietary behaviors (p < 0.001) that increase the risk for many oncology
toxicities and significantly increased goal setting during primary care visits. The
investigators have recently adapted MOHR to include SDoH such as transportation, food
access, medication affordability, safety at home, housing, and financial stability. Much
like the geriatric screen, MOHR provides information on health behaviors that may be at
risk, especially in an older population more likely to face comorbid conditions.
This proposal will integrate our evidence-based health risk assessment (MOHR) with a
geriatric health screener (G8) to assess and address the needs of older adults with
cancer. Key challenges to assessment of SDoH and cancer risks are the nonsystematic and
separate, non-integrated way these assessments are conducted and the limited time in
clinic visits to identify risks, and tailor treatment and goal setting to patient context
and priorities. When patients complete our MOHR web-based system, actionable information
on health risks and SDoH along with patients' priorities provides for more informed and
efficient patient-clinician interactions. This is an example of how well-designed,
contextually-appropriate technology developed with patients and clinicians can provide
important efficiencies to address clinical and implementation challenges.
In combining the extensive preliminary work in designing the modified G8 and the
demonstrated success of the MOHR automated assessment and feedback system with the
clinical and methodologic expertise of our team, the investigators are positioned to
successfully pilot the IA3-CP in the UCCC. This proposal addresses a clear gap in the
needs of older cancer patients and clinical teams and will lead to many future
collaborations including a UG3/UH3 MPI pragmatic trial submission.
INNOVATION:
Our proposed feasibility pilot will accelerate the implementation of patient-reported
measures to inform care planning for the diverse and at-risk population of older adults
with cancer. It will also advance transdisciplinary cancer research by demonstrating
integration of multiple risk issues in a pragmatic fashion using innovative D&I science
and engagement methods.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Age > /= 65
- Patient must agree to participate in all study-related activities
- English or Spanish speaking
- Attending initial visit to oncology
Exclusion criteria
- age < 65
- primary language other than English or Spanish
Gender:
All
Minimum age:
65 Years
Maximum age:
111 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Colorado Hospital
Address:
City:
Aurora
Zip:
80045
Country:
United States
Status:
Recruiting
Contact:
Last name:
Michaela Brtnikova
Phone:
303-724-2643
Email:
michaela.brtnikova@cuanschutz.edu
Investigator:
Last name:
Elizabeth Kessler, MD
Email:
Principal Investigator
Start date:
March 1, 2024
Completion date:
December 2026
Lead sponsor:
Agency:
University of Colorado, Denver
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
University of Colorado, Denver
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05871008
