Colorectal CancerNCT07403981
Advocacy, Partnership, Outreach, and Yielding Optimized Care for Oncology Patients
A study testing CHW/P Navigator Support and Social Services Resource List in people with Colorectal Cancer, run by Stanford University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- CHW/P Navigator Support and Social Services Resource List
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2026to 31 Jul 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Ability to understand and the willingness to provide written informed consent
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Stanford University
Palo Alto, California, 94304
Study Coordinator, 408-753-8976, apoyo_team@stanford.edu
Aaron J Dawes, MD, PhD
About this study
Official title: Advocacy, Partnership, Outreach, and Yielding Optimized Care for Oncology Patients (APOYO): A Community Health Worker Intervention for Latinx Colorectal Cancer Patients
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.
- Conditions
- Colorectal Cancer
- Being tested
- CHW/P Navigator Support, Social Services Resource List
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHW/P Navigator SupportBehavioural
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.
Social Services Resource ListOther
Participants receive a printed or digital list of local social service resources, including websites and phone numbers for enrollment and access to services.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: CHW/P Navigator Support |
| 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. Receives: Other: Social Services Resource List |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 6 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2026
- Study start1 Sep 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aaron J Dawes, MD, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07403981
- Sponsor's protocol ID
- IRB-82643
- Other IDs
- NCI-2026-06744
- Status last verified
- Oct 2026
- First submitted
- 4 Feb 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No