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Integrated Actionable Aging Assessment for Cancer Patients Pilot

Primary Purpose

Breast Cancer, Hodgkin Lymphoma, Kidney Cancer

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Assessment tool IA3-CP with SDoH
Assessment tool IA3-CP without SDoH
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Breast Cancer

Eligibility Criteria

65 Years - 111 Years (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    No Intervention

    Arm Label

    IA3-CP with SDoH

    IA3-CP only

    Control - usual care

    Arm Description

    Assess IA3-CP with SDoH and provide feedback (provider & patient)

    Assess IA3-CP only without added SDoH and provide feedback (provider & patient)

    Usual care: Assess IA3-CP without providing the feedback report

    Outcomes

    Primary Outcome Measures

    Patient reported receipt of quality illness care
    Measured by the Patient Assessment of Chronic illness Care (PACIC). The score ranges from 1-5 where higher scores mean a better outcome
    Number of referrals made and completed for geriatric, health behavior and SDoH issues
    Measured by data abstraction from EHR

    Secondary Outcome Measures

    Discussion of IA3-CP related issues in oncologist-patient encounter
    Measured by checklist adapted from the Roter interaction analysis system (RIAS) completed from recorded observation of patient-oncologist meeting
    Oncologist utility
    Did IA3-CP change your care plan? (yes/no) How helpful was it? (6 pt. scale)
    Proportion of patients that use IA3-CP screening tool
    Measured by clinic leadership report & observation

    Full Information

    First Posted
    April 24, 2023
    Last Updated
    August 21, 2023
    Sponsor
    University of Colorado, Denver
    Collaborators
    National Cancer Institute (NCI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05871008
    Brief Title
    Integrated Actionable Aging Assessment for Cancer Patients Pilot
    Official Title
    Integrated Actionable Aging Assessment for Cancer Patients Pilot
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 2023 (Anticipated)
    Primary Completion Date
    December 2024 (Anticipated)
    Study Completion Date
    December 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Colorado, Denver
    Collaborators
    National Cancer Institute (NCI)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Breast Cancer, Hodgkin Lymphoma, Kidney Cancer, Leukemia, Lymphoid Leukemia, Multiple Myeloma, Myeloid Leukemia, Monocytic Leukemia, Prostate Cancer, Bladder Cancer

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    35 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    IA3-CP with SDoH
    Arm Type
    Experimental
    Arm Description
    Assess IA3-CP with SDoH and provide feedback (provider & patient)
    Arm Title
    IA3-CP only
    Arm Type
    Experimental
    Arm Description
    Assess IA3-CP only without added SDoH and provide feedback (provider & patient)
    Arm Title
    Control - usual care
    Arm Type
    No Intervention
    Arm Description
    Usual care: Assess IA3-CP without providing the feedback report
    Intervention Type
    Other
    Intervention Name(s)
    Assessment tool IA3-CP with SDoH
    Intervention 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.
    Intervention Type
    Other
    Intervention Name(s)
    Assessment tool IA3-CP without SDoH
    Intervention 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.
    Primary Outcome Measure Information:
    Title
    Patient reported receipt of quality illness care
    Description
    Measured by the Patient Assessment of Chronic illness Care (PACIC). The score ranges from 1-5 where higher scores mean a better outcome
    Time Frame
    12 weeks
    Title
    Number of referrals made and completed for geriatric, health behavior and SDoH issues
    Description
    Measured by data abstraction from EHR
    Time Frame
    16 weeks
    Secondary Outcome Measure Information:
    Title
    Discussion of IA3-CP related issues in oncologist-patient encounter
    Description
    Measured by checklist adapted from the Roter interaction analysis system (RIAS) completed from recorded observation of patient-oncologist meeting
    Time Frame
    7 months
    Title
    Oncologist utility
    Description
    Did IA3-CP change your care plan? (yes/no) How helpful was it? (6 pt. scale)
    Time Frame
    7 months
    Title
    Proportion of patients that use IA3-CP screening tool
    Description
    Measured by clinic leadership report & observation
    Time Frame
    7 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    65 Years
    Maximum Age & Unit of Time
    111 Years
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Michaela Brtnikova
    Phone
    3037242643
    Email
    michaela.brtnikova@cuanschutz.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Bryan Ford
    Email
    bryan.ford@cuanschutz.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Russell E Glasgow
    Organizational Affiliation
    University of Colorado, Denver
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    Integrated Actionable Aging Assessment for Cancer Patients Pilot

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