Intervention Development Process for a Pragmatic Randomized Controlled Trial: The Thoracic Peri-Operative Integrative Surgical Care Evaluation Trial.

BACKGROUND: Use of complementary therapies is high among people with cancer despite research gaps. The Thoracic Peri-Operative Integrative Surgical Care Evaluation (POISE) Trial will evaluate the impact of an integrative care intervention delivered by naturopathic doctors (NDs) in conjunction with usual care for patients undergoing surgery for lung, gastric, and esophageal cancer. OBJECTIVES: To describe the multistep, multidisciplinary process of defining the integrative care intervention to be used in the Thoracic POISE trial using a principle-based approach that is pragmatic, holistic, safe, feasible, evidence driven, and consensus based. METHODS: An Intervention Development Committee (IDC) made up of a multidisciplinary team of health care providers (NDs, surgeons, oncologists, nurses, dietitians, physiotherapists, pharmacists, and psychologists), researchers, and patients was established to oversee the process. Potential intervention components were identified through a clinical practice survey and expert opinion. Systematic literature reviews were conducted and scores assigned based on the following criteria: usage, safety, goals, feasibility/scalability, and evidence. The IDC selected an intervention to be piloted that consists of a standard palette including core and optional components. Safety, known risks, and interactions with pharmaceuticals were evaluated using industry and professional monographs, a scoping literature review, and consultations with hospital pharmacists. RESULTS: The clinical practice survey and expert opinion identified 28 components for consideration. Following literature reviews, scoring, consensus from the IDC, and safety and interaction considerations, an intervention palette consisting of core and optional components was defined. The intervention options vary based on the patient's phase of treatment and symptom-specific needs. The intervention includes supplements, physical recommendations (exercise), nutritional counseling, and psychological support (audio scripts). CONCLUSION: Through a multistep, multidisciplinary process an integrative care intervention was developed for the Thoracic POISE trial. The intervention will be piloted in a single-arm feasibility study, followed by a single-center randomized controlled trial (RCT), and finally a multicenter RCT.

Naturopathic Oncology Care for Thoracic Cancers: A Practice Survey.

BACKGROUND AND OBJECTIVES: There is a lack of information on therapies recommended by naturopathic doctors (NDs) for lung and gastroesophageal cancer care. Study objectives were to: (1) identify the most common interventions considered for use by NDs; (2) identify interventions NDs recommend to support key therapeutic goals; and (3) identify potential contraindications between integrative and conventional therapies. METHODS: Oncology Association of Naturopathic Physicians (OncANP) members (n = 351) were invited to complete an electronic survey. Respondents provided information on interventions considered for thoracic cancer pre- and postoperatively across 4 therapeutic domains (supplemental natural health products, physical, mental/emotional, and nutritional), therapeutic goals, and contraindications. This survey was part of the development of the Thoracic Perioperative Integrative Surgical Evaluation trial. RESULTS: Forty-four NDs completed the survey (12.5% response rate), all of whom were trained at accredited colleges in North America and the majority of whom were Fellows of the American Board of Naturopathic Oncology (FABNO) (56.8%). NDs identified significantly more interventions in the postoperative compared to preoperative setting. The most frequently identified interventions included modified citrus pectin, arnica, omega-3 fatty acids, vitamin D, probiotics, exercise, acupuncture, meditation, stress reduction, low glycemic index diet, and Mediterranean diet. Potential contraindications with conventional treatment (surgery, chemotherapy, radiotherapy) differed across natural health products. CONCLUSIONS: These findings highlight naturopathic interventions with a high level of use in thoracic cancer care, describe and characterize therapeutic goals and the interventions used to achieve these goals, and provide insight on how practice changes relative to conventional cancer treatment phase.