Geriatric Assessment and Promotores (GAP) Pilot Feasibility Study (GAP)

December 4, 2025 updated by: University of California, Davis

Tailored Geriatric Assessment and Promotores Pilot Feasibility Study

The goal of this clinical trial is to test a new way to help older adults who have had cancer.

The researchers want to see if a program that assesses participants health and aging is achievable and makes a difference. A community health worker/promotora de salud will assess their health and provide coaching to help them feel better. This is important because older adults with cancer often have other health issues that are not addressed after completing treatment. The researchers want to make sure they get the care they need.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The proposed study is a single arm feasibility study of a supportive care intervention. Phase is not applicable because this is not a drug trial. The study involves enrolling older adult non-metastatic cancer survivors between 1 month and 24 months after the completion of any definitive (e.g., curative intent) cancer treatment. The objective is to determine if a Community Health Worker (CHW)-led geriatric assessment and coaching intervention to assess geriatric syndromes is a feasible modality in community-dwelling older adult cancer survivors. The tailored assessment intervention (geriatric assessment and coaching) is hypothesized to potentially be a feasible process to monitor patients that would otherwise not access geriatric services after completing cancer treatment. Coping and social support are hypothesized mediators to the relationship between physical function and health outcomes (e.g., physical function, mental health), influenced by sociodemographic contextual factors. Implementation science concepts, such as acceptability and scalability will also be collected. The study CHW will perform the geriatric assessment and coaching components with each of the patients in the study. The assessment component of the bundle intervention involves screening for frailty and cognition, occurring prior to the coaching session. The CHW will conduct a more thorough geriatric assessment for polypharmacy, depression, symptom burden, and social support. In follow up visits after the geriatric assessment the CHW will deliver the coaching component (derived from the Problem Solving Coaching Model) to participants. Each of the intervention sessions will consist of 45-minute appointments with tailored feedback of the geriatric assessment domains, caregiver and family support, and navigation to additional palliative care resources at the study institution. The researchers developed the content in the tailored assessment intervention from preliminary work and thorough review of scientific literature.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Sacramento, California, United States, 95817
        • University of California, Davis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age 65-90
  2. Able to understand study procedures and to comply with them for the entire length of the study.
  3. Diagnosis of Stage II-III breast, colorectal, or prostate cancer in within 1 to 24 months.
  4. Completed course of definitive therapy within 12 months from enrollment into the study.
  5. Proficient in English or Spanish
  6. Reside within the UC Davis Health catchment area.
  7. Has self-reported primary caregiver aged 21-90 years.

Exclusion Criteria:

  1. Contraindication to any study-related procedure or assessment.
  2. Patient is unable to independently deliver informed consent.
  3. Patient screens positive for cognitive impairment (6CIT > 8)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Feasibility Arm
All enrolled participants will receive the pilot Geriatric Assessment and Promotora Coaching intervention.
Behavioral: Geriatric Assessment and Promotora Coaching
In Visit 1 the community health worker/promotora will assess frailty, cognition, polypharmacy, depression, symptom burden, and social support. In Visits 2 and 3 the community health worker will deliver interpersonal communication techniques to deliver the problem solving coaching format, leverage cultural congruence with clients, and provide social support to assist in adopting healthy behaviors.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Describe the percentage of participants that complete 2 out of 3 study visits
Time Frame: 6 month
Calculate percentage of participants that complete study compared to total enrolled (Goal: 65)
6 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical Function
Time Frame: Baseline to 6 month
Patient-Reported Outcomes Measurement Information System [PROMIS] Physical Function
Baseline to 6 month
Depression, Anxiety, and Fatigue
Time Frame: Baseline to 6 month
Patient-Reported Outcomes Measurement Information System [PROMIS] Depression, Anxiety, and Fatigue
Baseline to 6 month
Self-Efficacy
Time Frame: Baseline to 6 month
Patient-Reported Outcomes Measurement Information System [PROMIS] Self-Efficacy
Baseline to 6 month
Emotional Support
Time Frame: Baseline to 6 month
Patient-Reported Outcomes Measurement Information System [PROMIS] Emotional Support
Baseline to 6 month
Quality of Life in Elderly Cancer Patients
Time Frame: Baseline to 6 month
European Organization for Research and Treatment of Cancer [EORTC] Quality of Life Questionnaire in the Elderly 14 item questionnaire [QLQ-ELD14]. Range 0 to 100, higher scores indicate better quality of life.
Baseline to 6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Davis

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Alex Fauer, PhD MS, UC Davis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 19, 2024

Primary Completion (Actual)

May 10, 2025

Study Completion (Actual)

November 10, 2025

Study Registration Dates

First Submitted

October 27, 2023

First Submitted That Met QC Criteria

November 3, 2023

First Posted (Actual)

November 9, 2023

Study Record Updates

Last Update Posted (Actual)

December 5, 2025

Last Update Submitted That Met QC Criteria

December 4, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1943526
  • 5K12CA138464 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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