Geriatric Assessment and Promotores (GAP) Pilot Feasibility Study

Study Overview
=================
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.

Official Title
-----------------
TAILORED GERIATRIC ASSESSMENT AND PROMOTORES PILOT FEASIBILITY STUDY

Conditions
-----------------
Breast Cancer, Colorectal Cancer, Prostate Cancer

Intervention / Treatment
-----------------
* Behavioral: Geriatric Assessment and Promotora Coaching


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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. Exclusion Criteria: Contraindication to any study-related procedure or assessment. Patient is unable to independently deliver informed consent. Patient screens positive for cognitive impairment (6CIT > 8)

Ages Eligible for Study
-----------------
Minimum Age: 65 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Feasibility Arm<br>All enrolled participants will receive the pilot Geriatric Assessment and Promotora Coaching intervention. | Behavioral: Geriatric Assessment and Promotora Coaching<br>* 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.<br>|

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 | Calculate percentage of participants that complete study compared to total enrolled (Goal: 65) | 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Describe physical function throughout the study period | PROMIS physical function | Baseline to 6 month | 
| Describe mental health outcomes | PROMIS: Depression, Anxiety, and Fatigue | Baseline to 6 month | 
| Describe self-efficacy | PROMIS Self Efficacy | Baseline to 6 month | 
| Describe perceived social support | PROMIS Emotional Support | Baseline to 6 month | 
| Describe quality of life | Quality of Life Questionnaire in the Elderly (ELD-14) | Baseline to 6 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
frailty, geriatrics, community health workers