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CompletedNCT06125145GAPUpdated Dec 5, 2025

Geriatric Assessment and Promotores (GAP) Pilot Feasibility Study

An interventional study of Geriatric Assessment and Promotora Coaching in Breast Cancer, Colorectal Cancer and Prostate Cancer, sponsored by University of California, Davis. Completed at 1 site in United States. Open to participants aged 65 Years to 90 Years. Per ClinicalTrials.gov, last updated 2025-12-05.

Sponsored by University of California, Davis · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
65 Years to 90 Years
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Breast Cancer
  • Colorectal Cancer
  • Prostate Cancer

Keywords

  • geriatrics
  • frailty
  • community health workers
03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 30 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

University of California, Davis is the lead sponsor of 798 studies on the registry; 146 are open to participants now.

Of its 65 completed or terminated interventional studies of FDA-regulated products, 43 (66%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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)
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    Feasibility Arm

    All enrolled participants will receive the pilot Geriatric Assessment and Promotora Coaching intervention.

    Behavioral: Geriatric Assessment and Promotora Coaching

Interventions

  • BehavioralGeriatric 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.

06

What researchers measure

Primary outcomes

  1. Describe the percentage of participants that complete 2 out of 3 study visits

    Calculate percentage of participants that complete study compared to total enrolled (Goal: 65)

    Time frame: 6 month

Secondary outcomes

  1. Physical Function

    Patient-Reported Outcomes Measurement Information System \[PROMIS\] Physical Function

    Time frame: Baseline to 6 month

  2. Depression, Anxiety, and Fatigue

    Patient-Reported Outcomes Measurement Information System \[PROMIS\] Depression, Anxiety, and Fatigue

    Time frame: Baseline to 6 month

  3. Self-Efficacy

    Patient-Reported Outcomes Measurement Information System \[PROMIS\] Self-Efficacy

    Time frame: Baseline to 6 month

  4. Emotional Support

    Patient-Reported Outcomes Measurement Information System \[PROMIS\] Emotional Support

    Time frame: Baseline to 6 month

  5. Quality of Life in Elderly Cancer Patients

    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.

    Time frame: Baseline to 6 month

07

Study locations

1 site
  • University of California, Davis
    Sacramento, California 95817, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 5, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06125145
Lead sponsor
University of California, Davis
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Nov 9, 2023
Start date
Apr 19, 2024
Primary completion
May 10, 2025
Completion
Nov 10, 2025
Last update
Dec 5, 2025

Study contacts

Alex Fauer, PhD MS
principal investigator · UC Davis

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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