AzTrials
AzTrials

Breast CancerNCT05871008

Integrated Actionable Aging Assessment for Cancer Patients Pilot

A study testing Assessment tool IA3-CP with SDoH and Assessment tool IA3-CP without SDoH in people with Breast Cancer and Hodgkin Lymphoma, run by University of Colorado, Denver at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 65 to 111 years
Conditions the study is for
Breast Cancer, Hodgkin Lymphoma, Kidney Cancer
What is being tested?
Assessment tool IA3-CP with SDoH and Assessment tool IA3-CP without SDoH
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
1 siteUnited States
Study dates
1 Mar 2024to Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 to 111 years
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Age > /= 65
  • Patient must agree to participate in all study-related activities
  • English or Spanish speaking
  • Attending initial visit to oncology

Who cannot join

  • age < 65
  • primary language other than English or Spanish

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Colorado Hospital

    Aurora, Colorado, 80045

Other trials in United States

About this study

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.

Read the 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.

Being tested
Assessment tool IA3-CP with SDoH, Assessment tool IA3-CP without SDoH
Medical subject headings
Breast Neoplasms, Hodgkin Disease, Kidney Neoplasms, Leukemia, Leukemia, Lymphoid, Multiple Myeloma, Leukemia, Myeloid, Leukemia, Monocytic, Acute

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Assessment tool IA3-CP with SDoHOther

    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.

  • Assessment tool IA3-CP without SDoHOther

    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.

Study groups in NCT05871008
Study groupRoleWhat they receive
IA3-CP with SDoHExperimentalAssess IA3-CP with SDoH and provide feedback (provider \& patient)
Receives: Other: Assessment tool IA3-CP with SDoH
IA3-CP onlyExperimentalAssess IA3-CP only without added SDoH and provide feedback (provider \& patient)
Receives: Other: Assessment tool IA3-CP without SDoH
Control - usual careNo interventionUsual care: Assess IA3-CP without providing the feedback report

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 12 weeks

  2. Number of referrals made and completed for geriatric, health behavior and SDoH issues

    Measured by data abstraction from EHR

    Measured: 16 weeks

Secondary outcomes (3)
  1. 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

    Measured: 7 months

  2. Oncologist utility

    Did IA3-CP change your care plan? (yes/no) How helpful was it? (6 pt. scale)

    Measured: 7 months

  3. Proportion of patients that use IA3-CP screening tool

    Measured by clinic leadership report \& observation

    Measured: 7 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 May 2023
  2. Study start1 Mar 2024
  3. Primary completion6 Aug 2024
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
35 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05871008
Sponsor's protocol ID
23-0440.cc
Other IDs
P50CA244688
Status last verified
Oct 2026
First submitted
24 Apr 2023
Last updated
3 Nov 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Assessment tool IA3-CP with SDoH and Assessment tool IA3-CP without SDoH in people with Breast Cancer and Hodgkin Lymphoma, run by University of Colorado, Denver at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient reported receipt of quality illness care (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in