Advocacy, Partnership, Outreach, and Yielding Optimized Care for Oncology Patients
ConditionColorectal Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorStanford University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
New diagnosis of colon or rectal cancer in the last 3 months
Identify as Latinx/Hispanic/Latino
Aged 18 years or older
Reside in and planning to receive care in Santa Clara County
Disqualifiers
Unable to speak and understand either Spanish or English
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
Trial design
Design model
Single group
Treatments tested in this trial
CHW/P Navigator Support
BehavioralA 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.
Social Services Resource List
Other interventionParticipants receive a printed or digital list of local social service resources, including websites and phone numbers for enrollment and access to services.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Community Health Worker (CHW)/Patient Navigator (Intervention Group)Experimental treatment 1 intervention
Group B: Usual Care plus Social Services Resource List (Control Group)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Quality of Life Score (EORTC QLQ-C30)
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.
Time frame
Baseline to 6 months after randomizationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov