Geriatric Assessment and Promotores (GAP) Pilot Feasibility Study

Breast Cancer Clinical Trial

— GAP  

Official title:

Tailored Geriatric Assessment and Promotores Pilot Feasibility Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06125145
• Other study ID #: CCSN014
• Status: Recruiting
• Phase: N/A
• Start date: March 21, 2024
• Est. completion date: September 10, 2025

Study information

• Verified date: April 2024
• Source: University of California, Davis
• Contact: Alex Fauer, PhD MS
• Phone: 916-734-2145
• Email: FauerOncology[@]ucdavis.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 49
• Est. completion date: September 10, 2025
• Est. primary completion date: March 21, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 90 Years

Eligibility

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)

Related Conditions & MeSH terms

• Breast Cancer
• Colorectal Cancer
• Colorectal Neoplasms
• Prostate Cancer

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.

Locations

Country	Name	City	State
United States	University of California, Davis	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Physical Function	Patient-Reported Outcomes Measurement Information System [PROMIS] Physical Function	Baseline to 6 month
Secondary	Depression, Anxiety, and Fatigue	Patient-Reported Outcomes Measurement Information System [PROMIS] Depression, Anxiety, and Fatigue	Baseline to 6 month
Secondary	Self-Efficacy	Patient-Reported Outcomes Measurement Information System [PROMIS] Self-Efficacy	Baseline to 6 month
Secondary	Emotional Support	Patient-Reported Outcomes Measurement Information System [PROMIS] Emotional Support	Baseline to 6 month
Secondary	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.	Baseline to 6 month