Clinical trial NCT06125145: Geriatric Assessment and Promotores (GAP) Pilot Feasibility Study
Official title: Tailored Geriatric Assessment and Promotores Pilot Feasibility Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast Cancer
Colorectal Cancer
Prostate Cancer
Keywords: geriatrics
frailty
community health workers
Lead sponsor: University of California, Davis
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2023-11-09
Enrollment: 49
Sex: ALL
Minimum age (years): 65
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Describe the percentage of participants that complete 2 out of 3 study visits
timeFrame: 6 month
Secondary outcomes:
measure: Physical Function
timeFrame: Baseline to 6 month
measure: Depression, Anxiety, and Fatigue
timeFrame: Baseline to 6 month
measure: Self-Efficacy
timeFrame: Baseline to 6 month
measure: Emotional Support
timeFrame: Baseline to 6 month
measure: Quality of Life in Elderly Cancer Patients
timeFrame: Baseline to 6 month
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California, Davis
state: California
Study officials:
affiliation: UC Davis
name: Alex Fauer, PhD MS
role: PRINCIPAL_INVESTIGATOR
References: