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- Klinische proef NCT05871008
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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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Colorado
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Aurora, Colorado, Verenigde Staten, 80045
- University of Colorado Hospital
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-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Onderzoek naar gezondheidsdiensten
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: IA3-CP with SDoH
Assess IA3-CP with SDoH and provide feedback (provider & patient) |
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. |
|
Experimenteel: IA3-CP only
Assess IA3-CP only without added SDoH and provide feedback (provider & patient) |
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. |
|
Geen tussenkomst: Control - usual care
Usual care: Assess IA3-CP without providing the feedback report |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Patient reported receipt of quality illness care
Tijdsspanne: 12 weeks
|
Measured by the Patient Assessment of Chronic illness Care (PACIC). The score ranges from 1-5 where higher scores mean a better outcome |
12 weeks
|
|
Number of referrals made and completed for geriatric, health behavior and SDoH issues
Tijdsspanne: 16 weeks
|
Measured by data abstraction from EHR |
16 weeks
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Discussion of IA3-CP related issues in oncologist-patient encounter
Tijdsspanne: 7 months
|
Measured by checklist adapted from the Roter interaction analysis system (RIAS) completed from recorded observation of patient-oncologist meeting |
7 months
|
|
Oncologist utility
Tijdsspanne: 7 months
|
Did IA3-CP change your care plan? (yes/no) How helpful was it? (6 pt. scale) |
7 months
|
|
Proportion of patients that use IA3-CP screening tool
Tijdsspanne: 7 months
|
Measured by clinic leadership report & observation |
7 months
|
Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Russell E Glasgow, University of Colorado, Denver
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Urogenitale ziekten
- Genitale ziekten
- Vaatziekten
- Hart-en vaatziekten
- Genitale neoplasmata, mannelijk
- Urogenitale neoplasmata
- Neoplasmata per site
- Neoplasmata
- Genitale ziekten, man
- Prostaat Ziekten
- Mannelijke urogenitale ziekten
- Nier Ziekten
- Urologische ziekten
- Vrouwelijke urogenitale ziekten
- Vrouwelijke urogenitale ziekten en zwangerschapscomplicaties
- Ziekten van het immuunsysteem
- Neoplasmata per histologisch type
- Hematologische ziekten
- Huidziektes
- Borst ziekten
- Lymfatische ziekten
- Lymfoproliferatieve aandoeningen
- Immunoproliferatieve aandoeningen
- Urologische neoplasmata
- Lymfoom
- Neoplasmata, plasmacel
- Hemostatische aandoeningen
- Paraproteïnemieën
- Bloed eiwit stoornissen
- Hemorragische aandoeningen
- Ziekten van de urineblaas
- Leukemie, myeloïde, acuut
- Huid- en bindweefselaandoeningen
- Hemische en lymfatische ziekten
- Prostaatneoplasmata
- Leukemie
- Leukemie, myeloïde
- Borstneoplasmata
- Leukemie, Lymfoïde
- Multipel myeloom
- Ziekte van Hodgkin
- Neoplasmata van de urineblaas
- Nierneoplasmata
- Leukemie, monocytisch, acuut
- Bevolkingskenmerken
- Gezondheidstoestand
- Demografie
- Gezondheid
- Sociale determinanten van gezondheid
Andere studie-ID-nummers
- 23-0440.cc
- P50CA244688 (Subsidie/contract van de Amerikaanse NIH)
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