AIMS Cancer Outcomes Study

Recruiting

• Conditions: Oncology; Advanced Cancer; Advanced Solid Tumor; Neoplasms; Neoplasm Malignant

• Registration Number: NCT04495790
• Lead Sponsor: Advanced Integrative Medical Science Institute

Brief 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?"

Study Timeline

• Study Start: 2020-05-18
• Study First Submitted: 2020-07-29
• Study First Submitted QC: 2020-07-31
• Study First Posted: 2020-08-03
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-30
• Last Update Posted: 2023-02-01
• Primary Completion: 2025-05-18
• Study Completion: 2030-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
AIM 1 (survival)	5 Years	Measure DFS and OS in advanced stage cancer patients who receive AIO treatments at AIMS Institute.

Secondary Outcome Measures

Name	Time	Method
AIM 3 (correlate survival with treatment)	5 Years	Correlate survival outcomes with treatments received.
AIM 2 (treatment)	5 Years	Describe AIO treatments prescribed and provided by AIMS physician and their medical staff.

Trial Locations

Locations (1)

AIMS Institute; 🇺🇸 Seattle, Washington, United States