Colorectal Cancer
Conditions
Brief summary
This study is a pilot feasibility randomized trial involving newly diagnosed colorectal cancer (CRC) patients who identify as Latinx. The study aims to leverage existing academic-community partnerships in Santa Clara County to develop and evaluate a multi-level community health worker/promotora (CHW/P) navigator intervention. If found effective, APOYO has the potential to affect clinical outcomes for Latinx colorectal cancer patients both directly and indirectly, including improving health-related quality of life, health care utilization, and reducing social needs.
Interventions
BEHAVIORALCHW/P Navigator Support
A Community Health Worker/Patient Navigator provides care coordination, social needs assessment, assistance accessing services, logistical support, and ongoing contact for up to 6 months following randomization.
OTHERSocial Services Resource List
Participants receive a printed or digital list of local social service resources, including websites and phone numbers for enrollment and access to services.
Sponsors
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. New diagnosis of colon or rectal cancer in the last 30 days 2. Identify as Latinx/Hispanic/Latino 3. Aged 18 years or older 4. Reside in and planning to receive care in Santa Clara County 5. Ability to understand and the willingness to provide written informed consent
Exclusion criteria
1. Unable to speak and understand either Spanish or English 2. Any concurrent malignancy other than nonmelanoma skin cancer or carcinoma in situ of the cervix. Patients with any previous malignancy without evidence of disease for \>3 years will be allowed to enter the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life Score (EORTC QLQ-C30) | Baseline to 6 months after randomization | Quality of life will be measured using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30), comparing participants randomized to CHW/P navigator support versus usual care with a social services resource list. Scores are linearly transformed to a 0-100 scale, with higher scores indicating better overall quality of life and functioning. |
Countries
United States
Contacts
CONTACTStudy Coordinator
PRINCIPAL_INVESTIGATORAaron J Dawes, MD, PhD, FACS, FASCRS
Stanford University
Outcome results
None listed