Virtual Mind-Body Exercises for People Having Pancreatic Surgery

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

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.

Study Overview

• Status: Completed
• Conditions: Pancreas Disease
• Intervention / Treatment: Other: Virtual mind-body group exercise classes; Other: Enhanced usual care

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Basking Ridge, New Jersey, United States, 07920
      • Memorial Sloan Kettering Basking Ridge (Consent Only)
    • Middletown, New Jersey, United States, 07748
      • Memorial Sloan Kettering Monmouth (Consent Only)
    • Montvale, New Jersey, United States, 07645
      • Memorial Sloan Kettering Bergen (Consent Only)
  • New York
    • Commack, New York, United States, 11725
      • Memorial Sloan Kettering Suffolk- Commack (Consent Only)
    • Harrison, New York, United States, 10604
      • Memorial Sloan Kettering Westchester (Consent Only)
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center (All Protocol Activities)
    • Uniondale, New York, United States, 11553
      • Memorial Sloan Kettering Nassau (Consent Only)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Virtual mind-body group exercise classes (VMB); Will be provided with the schedule and links to the web-based mind-body exercises offered by MSK in real-time via the Zoom video conferencing platform. Each session is led by a licensed clinician (e.g., licensed dance therapist, certified yoga instructor, nurse specialist/physical trainer) with specific expertise in the oncology setting.	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)
Active Comparator: Enhanced usual care (EUC); Pre-recorded self-care videos.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Investigators: Principal Investigator: Alice Wei, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): June 17, 2022
• Primary Completion (Actual): November 12, 2024
• Study Completion (Actual): November 12, 2024

Study Registration Dates

• First Submitted: June 20, 2022
• First Submitted That Met QC Criteria: June 20, 2022
• First Posted (Actual): June 24, 2022

Study Record Updates

• Last Update Posted (Estimated): November 18, 2024
• Last Update Submitted That Met QC Criteria: November 15, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Exercises; 22-070
• Additional Relevant MeSH Terms: Digestive System Diseases; Pancreatic Diseases
• Other Study ID Numbers: 22-070

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No