NCT04495790

AIMS Cancer Outcomes Study

Advanced Integrative Oncology Treatment for Adult and Pediatric Patients With Cancer: A Prospective Outcomes Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: Advanced Integrative Medical Science Institute · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

It is estimated that between 50 and 80% of cancer patients in the United States (US) supplement their conventional medical treatment regimen with some form of complementary or alternative medicine (CAM) therapy or practice. A smaller percentage of these patients receive medical treatment from naturopathic doctors (NDs) who are board certified in naturopathic oncology (Fellows of the American Board of Naturopathic Oncology, FABNO) or have equivalent experience in caring for cancer patients. This level of care is being defined here as Advanced Integrative Oncology (AIO). AIO clinics provide comprehensive science- and experience-based naturopathic medical oncology integrated with the individual patient's conventional medical treatment. Although there have been some studies of alternative and complementary medicine use by both adult and pediatric cancer patients, little is known about the effectiveness of naturopathic medicine provided to patients with cancer in an integrative setting. Increasing numbers of parents of children seek out naturopathic physicians and other integrative oncologists for evidence-based complementary integrative therapy that is coordinated with the child's standard oncology treatment plan. The AIMS Institute provides nutritional and botanical medicine care to children with leukemia, brain cancer, and osteosarcoma. Despite the widespread use of integrative oncology by children with cancer, little is known about the effectiveness of these therapies in pediatric cancer patients. While there is scientific evidence supporting specific treatments that are commonly used, systematic study of their effectiveness, especially when used in combination as commonly recommended, is sparse. We believe that an early step in the evaluation of clinical outcomes associated with CAM is to take a health services approach and seek to answer the question: "Does exposure to AIO services improve the clinical outcomes of patients with cancer?"

Conditions

• Neoplasms
• Neoplasm Malignant
• Advanced Cancer
• Advanced Solid Tumor
• Oncology

Timeline

• Start date: 2020-05-18
• Primary completion: 2025-05-18
• Completion: 2030-12-31
• First posted: 2020-08-03
• Last updated: 2023-02-01

Locations

1 site across 1 country: United States