Pancreas Disease Clinical Trial
Official title:
Pilot Study of Virtual Mind-Body Exercises for Patients Undergoing Pancreatic Surgery
NCT number | NCT05431556 |
Other study ID # | 22-070 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | June 17, 2022 |
Est. completion date | June 2025 |
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.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | June 2025 |
Est. primary completion date | June 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
United States | Memorial Sloan Kettering Basking Ridge (Consent Only) | Basking Ridge | 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 Monmouth (Consent Only) | Middletown | New Jersey |
United States | Memorial Sloan Kettering Bergen (Consent Only) | Montvale | New Jersey |
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 |
Lead Sponsor | Collaborator |
---|---|
Memorial Sloan Kettering Cancer Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 |
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