AIMS Cancer Outcomes Study (ACOS)
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|ClinicalTrials.gov Identifier: NCT04495790|
Recruitment Status : Recruiting
First Posted : August 3, 2020
Last Update Posted : August 4, 2020
|Condition or disease|
|Neoplasms Neoplasm Malignant Advanced Cancer Advanced Solid Tumor Oncology|
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?"
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||500 participants|
|Target Follow-Up Duration:||5 Years|
|Official Title:||Advanced Integrative Oncology Treatment for Adult and Pediatric Patients With Cancer: A Prospective Outcomes Study|
|Actual Study Start Date :||May 18, 2020|
|Estimated Primary Completion Date :||May 18, 2025|
|Estimated Study Completion Date :||December 31, 2030|
- AIM 1 (survival) [ Time Frame: 5 Years ]Measure DFS and OS in advanced stage cancer patients who receive AIO treatments at AIMS Institute.
- AIM 2 (treatment) [ Time Frame: 5 Years ]Describe AIO treatments prescribed and provided by AIMS physician and their medical staff.
- AIM 3 (correlate survival with treatment) [ Time Frame: 5 Years ]Correlate survival outcomes with treatments received.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04495790
|United States, Washington|
|Seattle, Washington, United States, 98102|
|Contact: Michelle Speaks, MBA 2064201321 email@example.com|
|Contact: Sunil K Aggarwal, MD, PhD, FAAPMR 2064201321 firstname.lastname@example.org|
|Principal Investigator: Therry Eparwa, DNP, ARNP, FNP-BC|
|Sub-Investigator: Leanna J Standish, ND, PhD, Lac, FABNO|
|Sub-Investigator: Sunil K Aggarwal, MD, PhD, FAAPMR|
|Sub-Investigator: Sonia S Malani, ND|