<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04495790</url>
  </required_header>
  <id_info>
    <org_study_id>ACOS</org_study_id>
    <nct_id>NCT04495790</nct_id>
  </id_info>
  <brief_title>AIMS Cancer Outcomes Study</brief_title>
  <acronym>ACOS</acronym>
  <official_title>Advanced Integrative Oncology Treatment for Adult and Pediatric Patients With Cancer: A Prospective Outcomes Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Advanced Integrative Medical Science Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Advanced Integrative Medical Science Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The overall aim is to describe disease-free survival (DFS) in early stage cancer patients and&#xD;
      three-year overall survival (OS) outcomes in advanced stage cancer patients receiving&#xD;
      Advanced Integrative Oncology (AIO) treatment in a prospective consecutive case series&#xD;
      outcomes study. We will collect data and study outcomes for patients with cancer who receive&#xD;
      care at AIMS Institute.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      It is estimated that between 50 and 80% of cancer patients in the United States (US)&#xD;
      supplement their conventional medical treatment regimen with some form of complementary or&#xD;
      alternative medicine (CAM) therapy or practice. A smaller percentage of these patients&#xD;
      receive medical treatment from naturopathic doctors (NDs) who are board certified in&#xD;
      naturopathic oncology (Fellows of the American Board of Naturopathic Oncology, FABNO) or have&#xD;
      equivalent experience in caring for cancer patients. This level of care is being defined here&#xD;
      as Advanced Integrative Oncology (AIO). AIO clinics provide comprehensive science- and&#xD;
      experience-based naturopathic medical oncology integrated with the individual patient's&#xD;
      conventional medical treatment.&#xD;
&#xD;
      Although there have been some studies of alternative and complementary medicine use by both&#xD;
      adult and pediatric cancer patients, little is known about the effectiveness of naturopathic&#xD;
      medicine provided to patients with cancer in an integrative setting. Increasing numbers of&#xD;
      parents of children seek out naturopathic physicians and other integrative oncologists for&#xD;
      evidence-based complementary integrative therapy that is coordinated with the child's&#xD;
      standard oncology treatment plan. The AIMS Institute provides nutritional and botanical&#xD;
      medicine care to children with leukemia, brain cancer, and osteosarcoma. Despite the&#xD;
      widespread use of integrative oncology by children with cancer, little is known about the&#xD;
      effectiveness of these therapies in pediatric cancer patients.&#xD;
&#xD;
      While there is scientific evidence supporting specific treatments that are commonly used,&#xD;
      systematic study of their effectiveness, especially when used in combination as commonly&#xD;
      recommended, is sparse. We believe that an early step in the evaluation of clinical outcomes&#xD;
      associated with CAM is to take a health services approach and seek to answer the question:&#xD;
      &quot;Does exposure to AIO services improve the clinical outcomes of patients with cancer?&quot;&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">May 18, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2030</completion_date>
  <primary_completion_date type="Anticipated">May 18, 2025</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>5 Years</target_duration>
  <primary_outcome>
    <measure>AIM 1 (survival)</measure>
    <time_frame>5 Years</time_frame>
    <description>Measure DFS and OS in advanced stage cancer patients who receive AIO treatments at AIMS Institute.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>AIM 2 (treatment)</measure>
    <time_frame>5 Years</time_frame>
    <description>Describe AIO treatments prescribed and provided by AIMS physician and their medical staff.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AIM 3 (correlate survival with treatment)</measure>
    <time_frame>5 Years</time_frame>
    <description>Correlate survival outcomes with treatments received.</description>
  </secondary_outcome>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Neoplasms</condition>
  <condition>Neoplasm Malignant</condition>
  <condition>Advanced Cancer</condition>
  <condition>Advanced Solid Tumor</condition>
  <condition>Oncology</condition>
  <eligibility>
    <study_pop>
      <textblock>
        All cancer patients who seek care at AIMS Institute and meet inclusion/exclusion criteria&#xD;
        are eligible to participate in this study. Participants will be informed and educated about&#xD;
        the prospective outcomes study by clinical staff as part of patient registration and the&#xD;
        clinical intake process. Patients may be referred to AIMS Institute by cancer care centers,&#xD;
        oncologists and other health care providers, or patients may be self-referred.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. A new patient coming in for a first office call (FOC) or first consultation via&#xD;
             telemedicine with a diagnosis of cancer, or&#xD;
&#xD;
          2. An established patient with a diagnosis of cancer receiving treatment at the AIMS&#xD;
             Institute;&#xD;
&#xD;
          3. If over 18 years of age are able to understand study design adequately and provide&#xD;
             signed informed consent (IC) to enrollment;&#xD;
&#xD;
          4. If younger than 18 years of age informed assent from the child and informed consent&#xD;
             from a parent or guardian who is able to understand the study design adequately and&#xD;
             provide signed informed consent for the pediatric patient;&#xD;
&#xD;
          5. A confirmed diagnosis of cancer based on medical oncology medical records.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients not diagnosed with cancer;&#xD;
&#xD;
          2. Telehealth patients;&#xD;
&#xD;
          3. Cannot read or understand English well enough to read and sign the consent form and&#xD;
             complete the questionnaires;&#xD;
&#xD;
          4. Unwilling to participate in the AIMS Institute observational study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>AIMS Institute</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98102</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Michelle Speaks, MBA</last_name>
      <phone>2064201321</phone>
      <email>mspeaks@aimsinstitute.net</email>
    </contact>
    <contact_backup>
      <last_name>Sunil K Aggarwal, MD, PhD, FAAPMR</last_name>
      <phone>2064201321</phone>
      <email>saggarwal@aimsinstitute.net</email>
    </contact_backup>
    <investigator>
      <last_name>Therry Eparwa, DNP, ARNP, FNP-BC</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Leanna J Standish, ND, PhD, Lac, FABNO</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Sunil K Aggarwal, MD, PhD, FAAPMR</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Sonia S Malani, ND</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Ladas EJ. Integrative Medicine in Childhood Cancer. J Altern Complement Med. 2018 Sep/Oct;24(9-10):910-915. doi: 10.1089/acm.2018.0224.</citation>
    <PMID>30247963</PMID>
  </reference>
  <reference>
    <citation>Neuhouser ML, Patterson RE, Schwartz SM, Hedderson MM, Bowen DJ, Standish LJ. Use of alternative medicine by children with cancer in Washington state. Prev Med. 2001 Nov;33(5):347-54. doi: 10.1006/pmed.2001.0911.</citation>
    <PMID>11676573</PMID>
  </reference>
  <reference>
    <citation>Ghiasuddin A, Wong J, Siu AM. Complementary and alternative medicine practices, traditional healing practices, and cultural competency in pediatric oncology in Hawai' i. J Integr Med. 2016 Sep;14(5):374-9. doi: 10.1016/S2095-4964(16)60267-6.</citation>
    <PMID>27641608</PMID>
  </reference>
  <reference>
    <citation>Lerman C, Trock B, Rimer BK, Jepson C, Brody D, Boyce A. Psychological side effects of breast cancer screening. Health Psychol. 1991;10(4):259-67. doi: 10.1037//0278-6133.10.4.259.</citation>
    <PMID>1915212</PMID>
  </reference>
  <reference>
    <citation>McHorney CA, Ware JE Jr, Lu JF, Sherbourne CD. The MOS 36-item Short-Form Health Survey (SF-36): III. Tests of data quality, scaling assumptions, and reliability across diverse patient groups. Med Care. 1994 Jan;32(1):40-66. doi: 10.1097/00005650-199401000-00004.</citation>
    <PMID>8277801</PMID>
  </reference>
  <reference>
    <citation>Seely D, Wu P, Fritz H, Kennedy DA, Tsui T, Seely AJ, Mills E. Melatonin as adjuvant cancer care with and without chemotherapy: a systematic review and meta-analysis of randomized trials. Integr Cancer Ther. 2012 Dec;11(4):293-303. doi: 10.1177/1534735411425484. Epub 2011 Oct 21.</citation>
    <PMID>22019490</PMID>
  </reference>
  <reference>
    <citation>Ma Y, Chapman J, Levine M, Polireddy K, Drisko J, Chen Q. High-dose parenteral ascorbate enhanced chemosensitivity of ovarian cancer and reduced toxicity of chemotherapy. Sci Transl Med. 2014 Feb 5;6(222):222ra18. doi: 10.1126/scitranslmed.3007154.</citation>
    <PMID>24500406</PMID>
  </reference>
  <reference>
    <citation>McCulloch M, Broffman M, van der Laan M, Hubbard A, Kushi L, Abrams DI, Gao J, Colford JM Jr. Colon cancer survival with herbal medicine and vitamins combined with standard therapy in a whole-systems approach: ten-year follow-up data analyzed with marginal structural models and propensity score methods. Integr Cancer Ther. 2011 Sep;10(3):240-59. doi: 10.1177/1534735411406539. Epub 2011 Sep 30.</citation>
    <PMID>21964510</PMID>
  </reference>
  <reference>
    <citation>Pierce JP, Stefanick ML, Flatt SW, Natarajan L, Sternfeld B, Madlensky L, Al-Delaimy WK, Thomson CA, Kealey S, Hajek R, Parker BA, Newman VA, Caan B, Rock CL. Greater survival after breast cancer in physically active women with high vegetable-fruit intake regardless of obesity. J Clin Oncol. 2007 Jun 10;25(17):2345-51. doi: 10.1200/JCO.2006.08.6819.</citation>
    <PMID>17557947</PMID>
  </reference>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>July 29, 2020</study_first_submitted>
  <study_first_submitted_qc>July 31, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2020</study_first_posted>
  <last_update_submitted>January 30, 2023</last_update_submitted>
  <last_update_submitted_qc>January 30, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 1, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Integrative Oncology</keyword>
  <keyword>Naturopathic Oncology</keyword>
  <keyword>Phytomedicine</keyword>
  <keyword>Metabolic Therapy</keyword>
  <keyword>Immunotherapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04495790
org study id: ACOS
nct id: NCT04495790
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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?"
observational model: Cohort
time perspective: Prospective
measure: AIM 1 (survival)
time frame: 5 Years
description: Measure DFS and OS in advanced stage cancer patients who receive AIO treatments at AIMS Institute.
measure: AIM 2 (treatment)
time frame: 5 Years
description: Describe AIO treatments prescribed and provided by AIMS physician and their medical staff.
measure: AIM 3 (correlate survival with treatment)
time frame: 5 Years
description: Correlate survival outcomes with treatments received.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
investigator: 
country: United States
citation: Ladas EJ. Integrative Medicine in Childhood Cancer. J Altern Complement Med. 2018 Sep/Oct;24(9-10):910-915. doi: 10.1089/acm.2018.0224.
PMID: 30247963
citation: Neuhouser ML, Patterson RE, Schwartz SM, Hedderson MM, Bowen DJ, Standish LJ. Use of alternative medicine by children with cancer in Washington state. Prev Med. 2001 Nov;33(5):347-54. doi: 10.1006/pmed.2001.0911.
PMID: 11676573
citation: Ghiasuddin A, Wong J, Siu AM. Complementary and alternative medicine practices, traditional healing practices, and cultural competency in pediatric oncology in Hawai' i. J Integr Med. 2016 Sep;14(5):374-9. doi: 10.1016/S2095-4964(16)60267-6.
PMID: 27641608
citation: Lerman C, Trock B, Rimer BK, Jepson C, Brody D, Boyce A. Psychological side effects of breast cancer screening. Health Psychol. 1991;10(4):259-67. doi: 10.1037//0278-6133.10.4.259.
PMID: 1915212
citation: McHorney CA, Ware JE Jr, Lu JF, Sherbourne CD. The MOS 36-item Short-Form Health Survey (SF-36): III. Tests of data quality, scaling assumptions, and reliability across diverse patient groups. Med Care. 1994 Jan;32(1):40-66. doi: 10.1097/00005650-199401000-00004.
PMID: 8277801
citation: Seely D, Wu P, Fritz H, Kennedy DA, Tsui T, Seely AJ, Mills E. Melatonin as adjuvant cancer care with and without chemotherapy: a systematic review and meta-analysis of randomized trials. Integr Cancer Ther. 2012 Dec;11(4):293-303. doi: 10.1177/1534735411425484. Epub 2011 Oct 21.
PMID: 22019490
citation: Ma Y, Chapman J, Levine M, Polireddy K, Drisko J, Chen Q. High-dose parenteral ascorbate enhanced chemosensitivity of ovarian cancer and reduced toxicity of chemotherapy. Sci Transl Med. 2014 Feb 5;6(222):222ra18. doi: 10.1126/scitranslmed.3007154.
PMID: 24500406
citation: McCulloch M, Broffman M, van der Laan M, Hubbard A, Kushi L, Abrams DI, Gao J, Colford JM Jr. Colon cancer survival with herbal medicine and vitamins combined with standard therapy in a whole-systems approach: ten-year follow-up data analyzed with marginal structural models and propensity score methods. Integr Cancer Ther. 2011 Sep;10(3):240-59. doi: 10.1177/1534735411406539. Epub 2011 Sep 30.
PMID: 21964510
citation: Pierce JP, Stefanick ML, Flatt SW, Natarajan L, Sternfeld B, Madlensky L, Al-Delaimy WK, Thomson CA, Kealey S, Hajek R, Parker BA, Newman VA, Caan B, Rock CL. Greater survival after breast cancer in physically active women with high vegetable-fruit intake regardless of obesity. J Clin Oncol. 2007 Jun 10;25(17):2345-51. doi: 10.1200/JCO.2006.08.6819.
PMID: 17557947
responsible party type: Sponsor
mesh term: Neoplasms