Stress Reduction Intervention versus Standard of Care in Patients with Stage II-III Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Undergoing Surgery, The PRESERVE Study

PRIMARY OBJECTIVE:

I. To investigate the feasibility of implementing a multimodal perioperative multimodality stress-reduction bundle (PSRB) in women undergoing primary debulking surgery (PDS) or interval debulking surgery (IDS) for advanced epithelial ovarian cancer (EOC).

SECONDARY OBJECTIVE:

I. To assess the safety of the PSRB, determined as the incidence of major complications (Memorial Sloan Kettering Cancer Center’s Surgical Secondary Events [SSE] grade >= 3) during the perioperative period (date of randomization until postoperative day [POD] 30).

II. To assess the impact of the PSRB on intraindividual change in additional serum markers of physiologic stress, including inflammatory cytokines and soluble factors (i.e., cortisol, vascular endothelial growth factor [VEGF], tumor necrosis factor (TNF) alpha, TNF-related apoptosis-inducing ligand [TRAIL], IL-6, IL-18, IL-8, and IL-10) from pre-intervention through the postoperative period.

III. To assess the impact of the PSRB on psychosocial stress, determined by the use of four validated questionnaires:

IIIa. Hospital Anxiety and Depression Scale (HADS);

IIIb. Impact of Event Scale (IES);

IIIc. Perceived Stress Scale (PSS);

IIId. Functional Assessment of Chronic Illness Therapy–Spiritual Well-Being (FACIT-Sp-12).

IV. To assess the impact of the PRSB on short-term clinical outcomes:

IVa. Intraoperative and postoperative use of narcotics and analgesics, measured as the amount of morphine milligram equivalents;

IVb. Length of hospital stay;

IVc. Return to bowel function, measured as the time to flatus;

IVd. Time from surgery to first dose of adjuvant chemotherapy.

V. To assess the impact of the PSRB on changes in oncogenic and immune-signaling pathways in tumors and peripheral blood using immunohistochemical (IHC) staining and gene-expression profiling.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP 1:

PRIOR TO SURGERY: Patients undergo MBRT and music therapy over 75 minutes for 7 days, and receive propranolol and etodolac orally (PO) twice daily (BID) for 7 days in the absence of unacceptable toxicity. Patients also undergo collection of blood and tissue samples throughout the trial.

DAY OF SURGERY: Patients receive propofol intravenously (IV) during surgery.

AFTER SURGERY: Patients undergo MBRT and music therapy over 60 minutes on days 3, 4, and 5. Patients also continue receiving propranolol PO BID for 16 days and etodolac PO BID for 14 days in the absence of unacceptable toxicity.

GROUP 2: Patients receive standard of care therapy before and after surgery. Patients also undergo collection of blood and tissue samples throughout the trial.

After completion of study intervention, patients are followed up for 30 days after discharge.