AIMS Cancer Outcomes Study (ACOS)

January 30, 2023 updated by: Advanced Integrative Medical Science Institute

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

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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98102
        • Recruiting
        • AIMS Institute
        • Contact:
        • 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All cancer patients who seek care at AIMS Institute and meet inclusion/exclusion criteria are eligible to participate in this study. Participants will be informed and educated about the prospective outcomes study by clinical staff as part of patient registration and the clinical intake process. Patients may be referred to AIMS Institute by cancer care centers, oncologists and other health care providers, or patients may be self-referred.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Advanced Integrative Medical Science Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 18, 2020

Primary Completion (Anticipated)

May 18, 2025

Study Completion (Anticipated)

December 31, 2030

Study Registration Dates

First Submitted

July 29, 2020

First Submitted That Met QC Criteria

July 31, 2020

First Posted (Actual)

August 3, 2020

Study Record Updates

Last Update Posted (Actual)

February 1, 2023

Last Update Submitted That Met QC Criteria

January 30, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACOS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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