Pancreas Disease
Conditions
Keywords
Exercises, 22-070
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.
Interventions
OTHERVirtual 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)
OTHEREnhanced 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.
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed