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Clinical Trials/NCT05431556
NCT05431556
Completed
N/A

Pilot Study of Virtual Mind-Body Exercises for Patients Undergoing Pancreatic Surgery

Memorial Sloan Kettering Cancer Center7 sites in 1 country29 target enrollmentJune 17, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Pancreas Disease
Sponsor
Memorial Sloan Kettering Cancer Center
Enrollment
29
Locations
7
Primary Endpoint
Feasibility of the Virtual Mind-Body Exercises program as measured by enrollment rate
Status
Completed
Last Updated
last year

Overview

Brief Summary

The purpose of this study is to find out if it is practical to provide 2 interventions, VMB exercise classes and EUC (pre-recorded self-care videos), during the perioperative period (before and after surgery) to improve health-related outcomes and quality of life for people undergoing a pancreatectomy.

Registry
clinicaltrials.gov
Start Date
June 17, 2022
End Date
November 12, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Age ≥ 18 years or older
  • Any pancreas disease (benign, pre-malignant, or malignant) and will be undergoing pancreatectomy
  • Has at least one week to participate in the study prior to the anticipated surgery date
  • Eastern Cooperative Oncology Group (ECOG) Performance status 0 or 1
  • English-speaking only

Exclusion Criteria

  • Unable to give informed consent due to cognitive impairment or impaired decisionmaking capacity
  • Cognitive impairment precluding response to study assessments
  • Received neoadjuvant or any chemoradiation in the past 60 days
  • Unwilling to accept random assignment
  • Unwilling to commit to the 12-week study time period
  • Unlikely to be compliant because of social factors that prevent patients from attending classes or doing home practice (e.g., unreliable internet, no access to a computer)

Outcomes

Primary Outcomes

Feasibility of the Virtual Mind-Body Exercises program as measured by enrollment rate

Time Frame: 1 year

total number of patients invited, and the total number of study participants will be recorded

Secondary Outcomes

  • improving patient-reported outcomes (PROs)(1 year)

Study Sites (7)

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