Integrated Actionable Aging Assessment for Cancer Patients Pilot

NCT05871008 | Active Not Recruiting

• 2 other identifiers: 23-0440.ccP50CA244688
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Hodgkin Lymphoma; Kidney Cancer; Leukemia; Lymphoid Leukemia; Multiple Myeloma; Myeloid Leukemia; Monocytic Leukemia; Prostate Cancer; Bladder Cancer

Outcome Measures

Primary Outcomes (2)

• 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

  12 weeks

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

  Measured by data abstraction from EHR

  16 weeks

Secondary Outcomes (3)

• Discussion of IA3-CP related issues in oncologist-patient encounter

  7 months

• Oncologist utility

  7 months

• Proportion of patients that use IA3-CP screening tool

  7 months

Study Arms (3)

IA3-CP with SDoH

EXPERIMENTAL

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

Other: Assessment tool IA3-CP with SDoH

IA3-CP only

EXPERIMENTAL

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

Other: Assessment tool IA3-CP without SDoH

Control - usual care

NO INTERVENTION

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

Interventions

Assessment tool IA3-CP with SDoH OTHER

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.

IA3-CP with SDoH

Assessment tool IA3-CP without SDoH OTHER

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.

IA3-CP only

Eligibility Criteria

• Age: 65 Years - 111 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Colorado, Denver: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Hodgkin Disease; Kidney Neoplasms; Leukemia; Leukemia, Lymphoid; Multiple Myeloma; Leukemia, Myeloid; Leukemia, Monocytic, Acute; Prostatic Neoplasms; Urinary Bladder Neoplasms

Interventions

Social Determinants of Health

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Lymphoma; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Hematologic Diseases; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Leukemia, Myeloid, Acute; Genital Neoplasms, Male; Genital Diseases, Male; Genital Diseases; Prostatic Diseases; Urinary Bladder Diseases

Intervention Hierarchy (Ancestors)

Health Status; Demography; Population Characteristics; Health

Study Officials

• Russell E Glasgow

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2023
• First Posted: May 23, 2023
• Study Start: March 1, 2024
• Primary Completion: August 6, 2024
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 15, 2025

Record last verified: 2025-09

Locations

US (1)