Virtual Mind-Body Exercises for People Having 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.

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Key information

Conditions

Pancreas Disease Behavior Digestive System Diseases Motor Activity Pancreatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Virtual mind-body group exercise classes

Other

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

Other

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.

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)

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start: 2022
Primary completion: 2024
Study completion: 2024
First posted: Jun 24, 2022
Registry last updated: Nov 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed