Virtual Mind-Body Exercises for People Having Pancreatic Surgery
- Conditions
- Pancreas Disease
- Interventions
- Other: Enhanced usual careOther: Virtual mind-body group exercise classes
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 29
- 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
- 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
- Arm && Interventions
Group Intervention Description Enhanced usual care (EUC) Enhanced usual care Pre-recorded self-care videos. Virtual mind-body group exercise classes (VMB) Virtual mind-body group exercise classes 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.
- 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