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Virtual Mind-Body Exercise Classes for Pancreatic Surgery Recovery
N/A
Recruiting
Led By Alice Wei, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) Performance status 0 or 1
English-speaking only
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study Summary
This trial will test whether two interventions, VMB exercise classes and EUC (pre-recorded self-care videos), can improve health outcomes and quality of life for people undergoing a pancreatectomy.
Who is the study for?
This trial is for adults over 18 who are English-speaking and have any type of pancreatic disease. They must be scheduled for pancreatectomy, able to participate in the study at least a week before surgery, and have good performance status (able to carry out daily activities). People can't join if they're not open to random group assignment, can't commit to 12 weeks, lack reliable internet or computer access, have cognitive impairments, or received recent chemoradiation.Check my eligibility
What is being tested?
The study is testing whether virtual mind-body exercise classes and enhanced usual care with pre-recorded self-care videos are practical during the perioperative period. It aims to improve health outcomes and quality of life after pancreatic surgery. Participants will either receive these interventions or continue with their normal care routines.See study design
What are the potential side effects?
Since this trial involves non-invasive practices like virtual exercises and educational videos rather than medication or invasive procedures, significant side effects are not expected. However, participants may experience general discomfort from engaging in new physical activities.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or can carry out light work.
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I speak English.
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I have a pancreas condition and will have surgery to remove part or all of it.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Feasibility of the Virtual Mind-Body Exercises program as measured by enrollment rate
Secondary outcome measures
improving patient-reported outcomes (PROs)
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Virtual mind-body group exercise classes (VMB)Experimental Treatment1 Intervention
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.
Group II: Enhanced usual care (EUC)Active Control1 Intervention
Pre-recorded self-care videos.
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Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,936 Previous Clinical Trials
588,821 Total Patients Enrolled
Alice Wei, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
1 Previous Clinical Trials
60 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can participate in the study for at least one week before my surgery.I am fully active or can carry out light work.I speak English.I have a pancreas condition and will have surgery to remove part or all of it.I am not open to being randomly assigned to a treatment group.I am 18 years old or older.I cannot commit to a 12-week study.I am unable to understand or make decisions due to cognitive issues.I have had chemotherapy or radiation therapy in the last 60 days.You have difficulty thinking or remembering things, which would make it hard for you to participate in the study assessments.
Research Study Groups:
This trial has the following groups:- Group 1: Enhanced usual care (EUC)
- Group 2: Virtual mind-body group exercise classes (VMB)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals have volunteered to participate in this clinical investigation?
"Affirmative. Per clinicaltrials.gov, the trial posted on June 17th 2022 is actively recruiting participants at this time. 60 patients need to be sourced from 7 distinct medical sites for this experiment's success."
Answered by AI
In what locale are the research endeavors for this experiment occurring?
"There are 7 medical sites recruiting patients, which includes Memorial Sloan Kettering Basking Ridge (Consent Only) in Basking Ridge, Memorial Sloan Kettering Monmouth (Consent Only) in Middletown, and Memorial Sloan Kettering Westchester (Consent Only), located Harrison. Additionally, there are other 4 clinical centres involved."
Answered by AI
Is the enrollment process for this experiment still open?
"Affirmative. Clinicaltrials.gov presents evidence that this clinical trial is still actively recruiting, with the initial posting on June 17th 2022 and most recent update taking place October 31st of the same year. In total, 60 participants are sought for enrollment at 7 different sites."
Answered by AI
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