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.
['Seely|Dugald|D|', 'Ennis|Julie E|JE|', 'McDonell|Ellen|E|', 'Fazekas|Anna|A|', 'Zhao|Linlu|L|', 'Asmis|Tim|T|', 'Auer|Rebecca C|RC|', 'Fergusson|Dean|D|', 'Kanji|Salmaan|S|', 'Maziak|Donna E|DE|', 'Ramsay|Tim|T|', 'Chamberland|Paul|P|', 'Spooner|Chris|C|', 'Threader|Jennifer|J|', 'Seely|Andrew|A|']
D006801:Humans D000073196:Integrative Oncology D019990:Perioperative Care D010865:Pilot Projects D011788:Quality of Life D016032:Randomized Controlled Trials as Topic D013899:Thoracic Neoplasms D019616:Thoracic Surgical Procedures
surgery integrative medicine lifestyle management natural health products naturopathic medicine quality of life thoracic cancer