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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
Sponsor:
Information provided by (Responsible Party):
Advanced Integrative Medical Science Institute

Study Description
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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.

Condition or disease
Neoplasms Neoplasm Malignant Advanced Cancer Advanced Solid Tumor Oncology

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 Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. AIM 1 (survival) [ Time Frame: 5 Years ]
    Measure DFS and OS in advanced stage cancer patients who receive AIO treatments at AIMS Institute.


Secondary Outcome Measures :
  1. AIM 2 (treatment) [ Time Frame: 5 Years ]
    Describe AIO treatments prescribed and provided by AIMS physician and their medical staff.

  2. AIM 3 (correlate survival with treatment) [ Time Frame: 5 Years ]
    Correlate survival outcomes with treatments received.


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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United States, Washington
AIMS Institute Recruiting
Seattle, Washington, United States, 98102
Contact: Michelle Speaks, MBA    2064201321    mspeaks@aimsinstitute.net   
Contact: Sunil K Aggarwal, MD, PhD, FAAPMR    2064201321    saggarwal@aimsinstitute.net   
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         
Sponsors and Collaborators
Advanced Integrative Medical Science Institute
More Information
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Publications:

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Responsible Party: Advanced Integrative Medical Science Institute
ClinicalTrials.gov Identifier: NCT04495790    
Other Study ID Numbers: ACOS
First Posted: August 3, 2020    Key Record Dates
Last Update Posted: August 4, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Advanced Integrative Medical Science Institute:
Integrative Oncology
Naturopathic Oncology
Phytomedicine
Metabolic Therapy
Immunotherapy
Additional relevant MeSH terms:
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Neoplasms