Prehabilitation for Improving Physical Function and Well-being in Patients Undergoing Esophagectomy for Esophageal Cancer, IMPROVE-Esophageal Trial

PRIMARY OBJECTIVES:

I. Conduct a pilot feasibility trial of a multidisciplinary prehabilitation program in patients with esophageal cancer (EC) scheduled for an esophagectomy.

Ia. Assess patient acceptability of a prehabilitation program prior to surgical resection (a-priori defined as 50%).

Ib. Assess adherence rate of designated prehabilitation intervention (i.e., proportion of exercise sessions completed versus number prescribed; proportion of protein drinks consumed versus number prescribed).

Ic. Assess feasibility of prehabilitation intervention, defined as 50% of participants complete ~70% of prescribed prehabilitation programming prior to surgical resection.

II. Examine the impact of a multidisciplinary prehabilitation program (exercise and nutrition) on physical function and psychosocial well-being in patients with EC undergoing an esophagectomy.

III. Evaluate participants’ impressions of the prescribed intervention and retroactively identified needs of pre-surgical care in adults with EC.

IIIa. Examine the facilitators, barriers, and preferences for prehabilitation in adults with EC from the perspective of participants.

IIIb. Identify gaps in pre-surgical care leading up to esophagectomy in adults with EC from the retrospective view of participants.

EXPLORATORY OBJECTIVE:

I. Assess post-surgical morbidity, healthcare utilization, and mortality by conducting post-surgical surveillance aligning with critical post-surgical clinical follow-ups (2 weeks, 6 weeks, and 4 months).

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP 1: Patients receive a demonstration of the prescribed exercises as well as an exercise manual and resistance bands for use during the intervention. Patients then participate in exercise, consisting of resistance exercise sessions over 30-45 minutes each and aerobic exercise sessions over 5-30 minutes each, 3-5 times per week for 2-8 weeks, up to the day of admission for planned surgery. Patients also receive Ensure nutritional supplement drinks orally (PO) twice daily (BID) for the duration of the intervention period, up to 6 days prior to planned surgery, at which point patients begin receiving IMPACT Advanced Recovery nutritional supplement drinks PO BID per standard of care until the day of surgery.

GROUP 2: Patients receive educational materials on exercise and nutrition during cancer treatment and then undergo surveillance and receive IMPACT Advanced Recovery nutritional supplement drinks PO BID per standard of care for up to 6 days prior to surgery. After completion of the study, patients may choose to meet with an exercise and cancer specialist to develop a personalized exercise program.

After completion of study intervention, patients are followed up at 2 and 6 weeks post-surgery and again at 4 months post-surgery.