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Trial Title:
Geriatric Assessment and Promotores (GAP) Pilot Feasibility Study
NCT ID:
NCT06125145
Condition:
Breast Cancer
Colorectal Cancer
Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Colorectal Neoplasms
Conditions: Keywords:
geriatrics
frailty
community health workers
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Geriatric Assessment and Promotora Coaching
Description:
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.
Arm group label:
Feasibility Arm
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.
Criteria for 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)
Gender:
All
Minimum age:
65 Years
Maximum age:
90 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
University of California, Davis
Address:
City:
Sacramento
Zip:
95817
Country:
United States
Status:
Recruiting
Contact:
Last name:
Alex Fauer, PhD MS
Phone:
916-734-2145
Email:
FauerOncology@ucdavis.edu
Investigator:
Last name:
Alex J Fauer, PhD MS
Email:
Principal Investigator
Start date:
March 21, 2024
Completion date:
September 10, 2025
Lead sponsor:
Agency:
University of California, Davis
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
University of California, Davis
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06125145
