AIMS Cancer Outcomes Study

NCT04495790 | Recruiting

• 1 other identifier: ACOS
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Neoplasms; Neoplasm Malignant; Advanced Cancer; Advanced Solid Tumor; Oncology

Keywords

Integrative Oncology; Naturopathic Oncology; Phytomedicine; Metabolic Therapy; Immunotherapy

Outcome Measures

Primary Outcomes (1)

• AIM 1 (survival)

  Measure DFS and OS in advanced stage cancer patients who receive AIO treatments at AIMS Institute.

  5 Years

Secondary Outcomes (2)

• AIM 2 (treatment)

  5 Years

• AIM 3 (correlate survival with treatment)

  5 Years

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• A new patient coming in for a first office call (FOC) or first consultation via telemedicine with a diagnosis of cancer, or
• An established patient with a diagnosis of cancer receiving treatment at the AIMS Institute;
• If over 18 years of age are able to understand study design adequately and provide signed informed consent (IC) to enrollment;
• 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;
• A confirmed diagnosis of cancer based on medical oncology medical records.

You may not qualify if:

• Patients not diagnosed with cancer;
• Telehealth patients;
• Cannot read or understand English well enough to read and sign the consent form and complete the questionnaires;
• Unwilling to participate in the AIMS Institute observational study.

Sponsors & Collaborators

• Advanced Integrative Medical Science Institute: lead

Study Sites (1)

AIMS Institute

Seattle, Washington, 98102, United States

RECRUITING

Related Publications (9)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Neoplasms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2020
• First Posted: August 3, 2020
• Study Start: May 18, 2020
• Primary Completion: May 18, 2025
• Study Completion (Estimated): December 31, 2030
• Last Updated: February 1, 2023

Record last verified: 2023-01

Locations

US (1)