Geriatric Assessment and Promotores (GAP) Pilot Feasibility Study

NCT06125145 | Completed

• 2 other identifiers: 19435265K12CA138464
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer; Colorectal Cancer; Prostate Cancer

Keywords

geriatrics; frailty; community health workers

Outcome Measures

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)

  6 month

Secondary Outcomes (5)

• Physical Function

  Baseline to 6 month

• Depression, Anxiety, and Fatigue

  Baseline to 6 month

• Self-Efficacy

  Baseline to 6 month

• Emotional Support

  Baseline to 6 month

• Quality of Life in Elderly Cancer Patients

  Baseline to 6 month

Study Arms (1)

Feasibility Arm

EXPERIMENTAL

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

Behavioral: Geriatric Assessment and Promotora Coaching

Interventions

Geriatric Assessment and Promotora Coaching BEHAVIORAL

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.

Feasibility Arm

Eligibility Criteria

• Age: 65 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of California, Davis: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of California, Davis

Sacramento, California, 95817, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Colorectal Neoplasms; Prostatic Neoplasms; Frailty

Interventions

Geriatric Assessment

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Status; Demography; Population Characteristics; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Alex Fauer, PhD MS

  UC Davis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2023
• First Posted: November 9, 2023
• Study Start: April 19, 2024
• Primary Completion: May 10, 2025
• Study Completion: November 10, 2025
• Last Updated: December 5, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)