Engagement of American Indians of Southwestern Tribal Nations in Cancer Genome Sequencing (PE-CGS)

New Mexico Cancer Care Alliance

Status: Enrolling

Conditions: Malignant Neoplasm

Treatments: Procedure: Return of Results; Procedure: Biospecimen Collection; Other: Survey Administration

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06207864

5U2CCA252973 (U.S. NIH Grant/Contract)

INST 2108

NCI-2023-02462 (Other Identifier)

Details and patient eligibility

About

This clinical trial studies engagement strategies for recruiting American Indians (AI) of Southwestern Tribal Nations for cancer genome sequencing. American Indians in the Southwest have higher rates of some types of cancer, such as cancers that arise in the liver, kidney, breast, and colon. American Indians with cancer may also live for less time than people from other population groups who have been treated for the same cancer. Damage to the cells of the body, acquired as people live, grow older, and are exposed to the environment, causes genetic changes in cells that can lead to cancer. This study may help researchers learn how these genetic changes in cells cause cancer and understand how and why cancer is arising in American Indians in the Southwest. This may help better prevent and treat cancer in the future.

Full description

PRIMARY OBJECTIVES:

The overall objective of the PE-CGS Research Center is to develop culturally appropriate, respectful, trusted, and collaborative means to engage and recruit American Indians affected by cancer (newly diagnosed cancer patients, patients undergoing cancer treatment, and cancer survivors) for molecular characterization of their tumors.

The clinical trial is embedded in the Patient Engagement Unit (PEU) jointly with the Engagement Optimization Unit (EOU)

The specific objectives for the PEU are to:

Conduct direct participant engagement with cancer patients/survivors, community advisors, and partners to refine and optimize methods/processes; Identify, recruit and consent eligible AI cancer patients/survivors; Implement tissue acquisition, epidemiologic, behavioral, and clinical data collection, conduct continuous assessment of performance benchmarks; Return clinical grade and clinically useful genomic data to participants with navigation to counseling and clinical resources as warranted and as they select.

The specific objectives of the EUO are to:

Finalize consenting process and informed consent by direct engagement of AI cancer patients, survivors, healthcare providers, genetic counselors, consenting staff, tribal and spiritual leaders and tribal governance; Determine AI cancer patients' and survivors' knowledge, attitudes, cultural beliefs, information needs, and communication preferences and practices regarding clinical genomics testing; Determine AI cancer patients' and survivors' perspectives on strategies to engage and recruit participants for clinical genomics testing.

Enrollment: 1,001 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The PE-CGS Research Center is only recruiting and sequencing tumors for adult-onset cancers (patients and survivors) among the American Indian Tribes, Nations, and Pueblos of New Mexico and adjacent states
• Male or female adults (18 years) or older
• Cancer patient undergoing active treatment or a cancer survivor
• Self-identify as American Indian

Exclusion criteria

• Cognitively impaired
• Adults unable to consent for themselves
• Individuals who are not yet adults
• Prisoners

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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1,001 participants in 1 patient group

Category 1 (biospecimens, surveys, interviews)

Experimental group

Description:

Cancer patients and survivors undergo collection of tissue, blood, saliva, and stool samples on study for genomic sequencing and microbiome analysis. Cancer patients and survivors also complete surveys and interviews on study pre and post intervention.

Treatment:

Other: Survey Administration

Procedure: Biospecimen Collection

Procedure: Return of Results