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Virtual Mind-Body Exercises for People Having Pancreatic Surgery

Primary Purpose

Pancreas Disease

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Virtual mind-body group exercise classes
Enhanced usual care
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pancreas Disease focused on measuring Exercises, 22-070

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Memorial Sloan Kettering Basking Ridge (Consent Only)Recruiting
  • Memorial Sloan Kettering Monmouth (Consent Only)Recruiting
  • Memorial Sloan Kettering Bergen (Consent Only)Recruiting
  • Memorial Sloan Kettering Suffolk- Commack (Consent Only)Recruiting
  • Memorial Sloan Kettering Westchester (Consent Only)Recruiting
  • Memorial Sloan Kettering Cancer Center (All Protocol Activities)Recruiting
  • Memorial Sloan Kettering Nassau (Consent Only)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Virtual mind-body group exercise classes (VMB)

Enhanced usual care (EUC)

Arm Description

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.

Pre-recorded self-care videos.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
June 20, 2022
Last Updated
October 31, 2022
Sponsor
Memorial Sloan Kettering Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT05431556
Brief Title
Virtual Mind-Body Exercises for People Having Pancreatic Surgery
Official Title
Pilot Study of Virtual Mind-Body Exercises for Patients Undergoing Pancreatic Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 17, 2022 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreas Disease
Keywords
Exercises, 22-070

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Virtual mind-body group exercise classes (VMB)
Arm Type
Experimental
Arm Description
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.
Arm Title
Enhanced usual care (EUC)
Arm Type
Active Comparator
Arm Description
Pre-recorded self-care videos.
Intervention Type
Other
Intervention Name(s)
Virtual mind-body group exercise classes
Intervention Description
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)
Intervention Type
Other
Intervention Name(s)
Enhanced usual care
Intervention Description
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 Outcome Measure Information:
Title
Feasibility of the Virtual Mind-Body Exercises program as measured by enrollment rate
Description
total number of patients invited, and the total number of study participants will be recorded
Time Frame
1 year
Secondary Outcome Measure Information:
Title
improving patient-reported outcomes (PROs)
Description
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.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alice Wei, MD
Phone
212-639-5643
Email
weia@mskcc.org
First Name & Middle Initial & Last Name or Official Title & Degree
Jun Mao, MD, MSCE
Phone
646-608-8552
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alice Wei, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Basking Ridge (Consent Only)
City
Basking Ridge
State/Province
New Jersey
ZIP/Postal Code
07920
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alice Wei, MD
Phone
212-639-5643
Facility Name
Memorial Sloan Kettering Monmouth (Consent Only)
City
Middletown
State/Province
New Jersey
ZIP/Postal Code
07748
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alice Wei, MD
Phone
212-639-5643
Facility Name
Memorial Sloan Kettering Bergen (Consent Only)
City
Montvale
State/Province
New Jersey
ZIP/Postal Code
07645
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alice Wei, MD
Phone
212-639-5643
Facility Name
Memorial Sloan Kettering Suffolk- Commack (Consent Only)
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alice Wei, MD
Phone
212-639-5643
Facility Name
Memorial Sloan Kettering Westchester (Consent Only)
City
Harrison
State/Province
New York
ZIP/Postal Code
10604
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alice Wei, MD
Phone
212-639-5643
Facility Name
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alice Wei, MD
Phone
212-639-5643
First Name & Middle Initial & Last Name & Degree
Jun Mao, MD, MSCE
Phone
646-608-8552
Facility Name
Memorial Sloan Kettering Nassau (Consent Only)
City
Uniondale
State/Province
New York
ZIP/Postal Code
11553
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alice Wei, MD
Phone
212-639-5643

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Links:
URL
http://www.mskcc.org/mskcc/html/44.cfm
Description
Memorial Sloan Kettering Cancer Center

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Virtual Mind-Body Exercises for People Having Pancreatic Surgery

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