Virtual Mind-Body Exercises for People Having Pancreatic Surgery

Not Applicable

Completed

• Conditions: Pancreas Disease

• Registration Number: NCT05431556
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-17
• Study First Submitted: 2022-06-20
• Study First Submitted QC: 2022-06-20
• Study First Posted: 2022-06-24
• Status Verified: 2024-11
• Primary Completion: 2024-11-12
• Study Completion: 2024-11-12
• Last Update Submitted: 2024-11-15
• Last Update Posted: 2024-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Feasibility of the Virtual Mind-Body Exercises program as measured by enrollment rate	1 year	total number of patients invited, and the total number of study participants will be recorded

Secondary Outcome Measures

Name	Time	Method
improving patient-reported outcomes (PROs)	1 year	Changes in HADS anxiety scores. The Hospital Anxiety and Depression Scale (HADS) will be used to explore the effect of treatments on psychological distress, specifically on anxiety. HADS is a 14-item scale with seven items measuring depression and seven items measuring anxiety. Each item is answered by the patient on a four-point (0-3) response category; possible scores range from 0-21 for anxiety and depression, with higher scores indicating higher symptomatology. Established cutoffs are: 0-7 not significant; 8-10 subclinical; and 11-21 clinically significant depression/anxiety.

Trial Locations

Locations (7)

Memorial Sloan Kettering Basking Ridge (Consent Only); 🇺🇸 Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth (Consent Only); 🇺🇸 Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen (Consent Only); 🇺🇸 Montvale, New Jersey, United States

Memorial Sloan Kettering Suffolk- Commack (Consent Only); 🇺🇸 Commack, New York, United States

Memorial Sloan Kettering Westchester (Consent Only); 🇺🇸 Harrison, New York, United States

Memorial Sloan Kettering Cancer Center (All Protocol Activities); 🇺🇸 New York, New York, United States

Memorial Sloan Kettering Nassau (Consent Only); 🇺🇸 Uniondale, New York, United States