Virtual Mind-Body Exercises for People Having Pancreatic Surgery
Pilot Study of Virtual Mind-Body Exercises for Patients Undergoing Pancreatic Surgery
1 other identifier
interventional
29
1 country
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2022
Typical duration for not_applicable
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 17, 2022
CompletedFirst Submitted
Initial submission to the registry
June 20, 2022
CompletedFirst Posted
Study publicly available on registry
June 24, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 12, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
November 12, 2024
CompletedNovember 18, 2024
November 1, 2024
2.4 years
June 20, 2022
November 15, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
improving patient-reported outcomes (PROs)
1 year
Study Arms (2)
Virtual mind-body group exercise classes (VMB)
EXPERIMENTALWill 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.
Enhanced usual care (EUC)
ACTIVE COMPARATORPre-recorded self-care videos.
Interventions
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)
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Memorial Sloan Kettering Basking Ridge (Consent Only)
Basking Ridge, New Jersey, 07920, United States
Memorial Sloan Kettering Monmouth (Consent Only)
Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering Bergen (Consent Only)
Montvale, New Jersey, 07645, United States
Memorial Sloan Kettering Suffolk- Commack (Consent Only)
Commack, New York, 11725, United States
Memorial Sloan Kettering Westchester (Consent Only)
Harrison, New York, 10604, United States
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065, United States
Memorial Sloan Kettering Nassau (Consent Only)
Uniondale, New York, 11553, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alice Wei, MD
Memorial Sloan Kettering Cancer Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 20, 2022
First Posted
June 24, 2022
Study Start
June 17, 2022
Primary Completion
November 12, 2024
Study Completion
November 12, 2024
Last Updated
November 18, 2024
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will share
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.