Clinical trial NCT04495790: AIMS Cancer Outcomes Study
Official title: Advanced Integrative Oncology Treatment for Adult and Pediatric Patients With Cancer: A Prospective Outcomes Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Neoplasms
Neoplasm Malignant
Advanced Cancer
Advanced Solid Tumor
Oncology
Keywords: Integrative Oncology
Naturopathic Oncology
Phytomedicine
Metabolic Therapy
Immunotherapy
Lead sponsor: Advanced Integrative Medical Science Institute
Sponsor class: OTHER
First posted: 2020-08-03
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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?"

Eligibility 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.

Primary outcomes:
measure: AIM 1 (survival)
timeFrame: 5 Years
Secondary outcomes:
measure: AIM 2 (treatment)
timeFrame: 5 Years
measure: AIM 3 (correlate survival with treatment)
timeFrame: 5 Years
Other outcomes:
Locations:
city: Seattle
country: United States
facility: AIMS Institute
state: Washington
Study officials:
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