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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Community Health Worker (CHW)/Patient Navigator (Intervention Group) | Experimental | Participants randomized to the intervention group will be assigned a CHW/P who will provide support for up to 6 months after randomization. CHW/Ps will attend the initial oncology visit when possible, review and explain the treatment plan, assist with scheduling and logistics (e.g., transportation, language services), complete a social needs assessment, connect patients to social support services, and offer peer support connections. CHW/Ps will maintain regular contact with patients, at least every other week for the first 3 months, and be available by phone as needed for an additional 3 months. They will also alert the clinical team if the patient expresses unresolved concerns or questions. |
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| Usual Care plus Social Services Resource List (Control Group) | Active Comparator | Participants in the control group will receive a printed or digital list of local social service resources, including websites and phone numbers, but will not receive CHW/P support or navigation services. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CHW/P Navigator Support | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to 6 months after randomization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yessica Mulet | Contact | 650 725-7792 | yessicam@stanford.edu |
| Name | Affiliation | Role |
|---|---|---|
| Aaron J Dawes, MD, PhD, FACS, FASCRS | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Palo Alto | California | 94304 | United States |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| Social Services Resource List | Other | Participants receive a printed or digital list of local social service resources, including websites and phone numbers for enrollment and access to services. |
|
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |