Neoplasms Clinical Trial
— ACOSOfficial title:
Advanced Integrative Oncology Treatment for Adult and Pediatric Patients With Cancer: A Prospective Outcomes Study
NCT number | NCT04495790 |
Other study ID # | ACOS |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | May 18, 2020 |
Est. completion date | December 31, 2030 |
Verified date | January 2023 |
Source | Advanced Integrative Medical Science Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
The overall aim is to describe disease-free survival (DFS) in early stage cancer patients and three-year overall survival (OS) outcomes in advanced stage cancer patients receiving Advanced Integrative Oncology (AIO) treatment in a prospective consecutive case series outcomes study. We will collect data and study outcomes for patients with cancer who receive care at AIMS Institute.
Status | Recruiting |
Enrollment | 500 |
Est. completion date | December 31, 2030 |
Est. primary completion date | May 18, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: 1. A new patient coming in for a first office call (FOC) or first consultation via telemedicine with a diagnosis of cancer, or 2. An established patient with a diagnosis of cancer receiving treatment at the AIMS Institute; 3. If over 18 years of age are able to understand study design adequately and provide signed informed consent (IC) to enrollment; 4. If younger than 18 years of age informed assent from the child and informed consent from a parent or guardian who is able to understand the study design adequately and provide signed informed consent for the pediatric patient; 5. A confirmed diagnosis of cancer based on medical oncology medical records. Exclusion Criteria: 1. Patients not diagnosed with cancer; 2. Telehealth patients; 3. Cannot read or understand English well enough to read and sign the consent form and complete the questionnaires; 4. Unwilling to participate in the AIMS Institute observational study. |
Country | Name | City | State |
---|---|---|---|
United States | AIMS Institute | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
Advanced Integrative Medical Science Institute |
United States,
Ghiasuddin A, Wong J, Siu AM. Complementary and alternative medicine practices, traditional healing practices, and cultural competency in pediatric oncology in Hawai' i. J Integr Med. 2016 Sep;14(5):374-9. doi: 10.1016/S2095-4964(16)60267-6. — View Citation
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | AIM 1 (survival) | Measure DFS and OS in advanced stage cancer patients who receive AIO treatments at AIMS Institute. | 5 Years | |
Secondary | AIM 2 (treatment) | Describe AIO treatments prescribed and provided by AIMS physician and their medical staff. | 5 Years | |
Secondary | AIM 3 (correlate survival with treatment) | Correlate survival outcomes with treatments received. | 5 Years |
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