Geriatric Assessment and Promotores (GAP) Pilot Feasibility Study

Not Applicable

Active, not recruiting

• Conditions: Prostate Cancer; Breast Cancer; Colorectal Cancer
• Interventions: Behavioral: Geriatric Assessment and Promotora Coaching

• Registration Number: NCT06125145
• Lead Sponsor: University of California, Davis

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.

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 Timeline

• Study First Submitted: 2023-10-27
• Study First Submitted QC: 2023-11-03
• Study First Posted: 2023-11-09
• Study Start: 2024-04-19
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-01
• Last Update Posted: 2025-04-04
• Primary Completion: 2025-04-19
• Study Completion: 2025-09-10

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 49

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Feasibility Arm	Geriatric Assessment and Promotora Coaching	All enrolled participants will receive the pilot Geriatric Assessment and Promotora Coaching intervention.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Self-Efficacy	Baseline to 6 month	Patient-Reported Outcomes Measurement Information System \[PROMIS\] Self-Efficacy
Physical Function	Baseline to 6 month	Patient-Reported Outcomes Measurement Information System \[PROMIS\] Physical Function
Depression, Anxiety, and Fatigue	Baseline to 6 month	Patient-Reported Outcomes Measurement Information System \[PROMIS\] Depression, Anxiety, and Fatigue
Quality of Life in Elderly Cancer Patients	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.
Emotional Support	Baseline to 6 month	Patient-Reported Outcomes Measurement Information System \[PROMIS\] Emotional Support

Trial Locations

Locations (1)

University of California, Davis; 🇺🇸 Sacramento, California, United States