Virtual Mind-Body Exercises for People Having Pancreatic Surgery

Pancreas Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05431556
• Other study ID #: 22-070
• Status: Recruiting
• Phase: N/A
• Start date: June 17, 2022
• Est. completion date: June 2025

Study information

• Verified date: October 2023
• Source: Memorial Sloan Kettering Cancer Center
• Contact: Alice Wei, MD
• Phone: 212-639-5643
• Email: weia[@]mskcc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Pancreas Disease
• Pancreatic Diseases

Intervention

Other:
• Virtual mind-body group exercise classes
Pre-operative period (baseline/intake day to day before surgery): mid- to high intensity classes focusing on aerobic physical activity, relaxation, and stress management (classes: Fitness for Everyone, Tai Chi, Mat Yoga, Dance Cardio, Meditation, Core Strength, Music Therapy) Immediate post-operative period (post-operative hospitalization to 2 weeks after surgery): low- to mid-intensity classes focusing on relaxation, stress management and low-impact physical activity (classes: Chair Yoga, Dance Therapy, Meditation, Music Therapy) Late post-operative period (3-12 weeks after surgery): mid- to high-intensity classes focusing on aerobic physical activity, relaxation, and stress management (classes: Fitness for Everyone, Tai Chi, Mat Yoga, Dance Cardio, Meditation, Core Strength, Music Therapy)
• Enhanced usual care
EUC arm will be referred to MSK's multimedia page on the Integrative Medicine website to access pre-recorded mind-body videos on their own time. These videos are 15-60 minutes in duration and consist of educational and self-care videos, including guided meditation and Tai Chi.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Basking Ridge (Consent Only)	Basking Ridge	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 Monmouth (Consent Only)	Middletown	New Jersey
United States	Memorial Sloan Kettering Bergen (Consent Only)	Montvale	New Jersey
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

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of the Virtual Mind-Body Exercises program as measured by enrollment rate	total number of patients invited, and the total number of study participants will be recorded	1 year
Secondary	improving patient-reported outcomes (PROs)	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.	1 year

External Links

•   Memorial Sloan Kettering Cancer Center