Virtual Mind-Body Exercises for People Having Pancreatic Surgery

NCT ID: NCT05431556

Last Updated: 2024-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-17

Study Completion Date

2024-11-12

Brief Summary

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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

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Conditions

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Pancreas Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Virtual mind-body group exercise classes (VMB)

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 Type EXPERIMENTAL

Virtual mind-body group exercise classes

Intervention Type OTHER

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)

Enhanced usual care (EUC)

Pre-recorded self-care videos.

Group Type ACTIVE_COMPARATOR

Enhanced usual care

Intervention Type OTHER

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.

Interventions

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Virtual 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)

Intervention Type OTHER

Enhanced 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.

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alice Wei, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

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Memorial Sloan Kettering Basking Ridge (Consent Only)

Basking Ridge, New Jersey, United States

Site Status

Memorial Sloan Kettering Monmouth (Consent Only)

Middletown, New Jersey, United States

Site Status

Memorial Sloan Kettering Bergen (Consent Only)

Montvale, New Jersey, United States

Site Status

Memorial Sloan Kettering Suffolk- Commack (Consent Only)

Commack, New York, United States

Site Status

Memorial Sloan Kettering Westchester (Consent Only)

Harrison, New York, United States

Site Status

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, United States

Site Status

Memorial Sloan Kettering Nassau (Consent Only)

Uniondale, New York, United States

Site Status

Countries

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United States

Related Links

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http://www.mskcc.org/mskcc/html/44.cfm

Memorial Sloan Kettering Cancer Center

Other Identifiers

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22-070

Identifier Type: -

Identifier Source: org_study_id

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