Stage I of the Thoracic-POISE study will pilot-test a broad-based, multi-agent integrative care intervention delivered by naturopathic doctors in conjunction with standard surgical and oncologic care of people with thoracic cancer.
Despite enormous advances in thoracic surgery and oncology, two critical issues concern patients undergoing curative-intent surgery for lung, gastric and esophageal cancer: first, a majority (\~60%) of patients experience minor and major adverse events occurring during and in the days following surgery; second, patients worry about the significant risk of cancer recurrence and mortality months to years after surgery. These issues, combined with side effects of chemotherapy and radiation, have detrimental effects on health-related quality of life (HRQoL). On a deeper level, there is the problem of an ongoing failure to integrate and evaluate the best of what complementary medicine has to offer surgical oncology care. The Thoracic-POISE Project has the overarching goal of improving care for thoracic cancer patients by impacting HRQoL, reducing surgical adverse events, prolonging overall survival and pioneering integrative care delivery. This multi-stage project aims to design, pilot-test and evaluate a broad-based, multi-agent, evidence-based integrative care program to be delivered by naturopathic doctors (ND) in conjunction with standard surgical and oncologic care. It is hypothesized that this integrative care program will improve HRQoL as well as reduce surgical adverse events and improve cancer survival. Stage I of the project will pilot-test the intervention and outcomes collection in a single-arm, feasibility study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
22
Standardized supplemental/natural health product, physical, nutritional and mental/emotional recommendations based on the phases of standard care (neo-adjuvant, perioperative, adjuvant and long-term maintenance).
Ottawa General Hospital
Ottawa, Ontario, Canada
Ottawa Integrative Cancer Centre
Ottawa, Ontario, Canada
Feasibility of study protocol
Percentage of participants who complete all assessments and integrative care appointments
Time frame: Enrollment - 1 year post surgery
Compliance: supplemental intervention
Count of missed doses assessed by patient diary.
Time frame: Enrollment - 1 year post surgery
Compliance: nutritional intervention
Mediterranean diet score calculated by food frequency questionnaire administered at enrollment and 1 year post surgery
Time frame: Enrollment - 1 year post surgery
Compliance: physical intervention
Extent of adherence to physical activity recommendations assessed using a patient diary.
Time frame: Enrollment - 1 year post surgery
Compliance: mental/emotional domain
Number of days audio-recordings were used assessed by patient diary.
Time frame: Enrollment - 1 year post surgery
Communication between practitioners
Number of communications (phone, consult note, etc.) between integrative and standard care practitioners per participant
Time frame: Enrollment - 1 year post surgery
Qualitative experience of care and study protocol
Semi-structured interviews with thematic analysis
Time frame: Enrollment - 1 year post surgery
Feasibility of recruitment
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Percentage of participants recruited out of potentially eligible patients invited.
Time frame: Enrollment