Personal Resilience Empowerment Program Study

September 20, 2021 updated by: Hackensack Meridian Health

Personal Resilience Empowerment Program (PREP) in the Perioperative Setting of Surgically Treated Cancer Patients

The Personal Resilience Empowerment Program (PREP) at Hackensack Meridian Integrative Health & Medicine was designed in Legacy Meridian to assist all selected patients with upcoming hospitalization. For the "Personal Resilience Empowerment Program (PREP) in the perioperative setting of surgically treated cancer patients", hereafter "the Project or PREP", the Hackensack Meridian Integrative Health & Medicine is designing a new pilot program to focus on the needs of oncology patients.

All patients diagnosed with cancer that will undergo a scheduled surgical (Hepato-Biliary, and Thoracic) procedure in Hackensack Meridian Health and specifically in the Jersey Shore University Medical Center, will be eligible to participate (for more details please see eligibility criteria, section 4).

Overall, this pilot project will include 5 coaching sessions and an introductory session/visit that will take place on the physician's office. The initial physician visit will focus on patient eligibility, introduction to the Project, informed consent and a pre-intervention survey and will be conducted by the principal investigator or one of the sub-investigators listed above. The following 5 sessions will be conducted by one of the integrative health coaches/registered nurses (for details please see section 5). A post-intervention survey will be completed during the final session and repeated at one month, and at 3 months from the final session.

The goal of this project is to investigate whether using the PREP as an intervention in patients diagnosed with cancer would result in improving various metrics including improvements to resilience, sleep, activity, purpose, nutrition, empowerment to manage one's own health and well-being, decrease in pain medication use and more rapid return to previous functional status according to Eastern Cooperative Oncology Group (ECOG).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

37

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Neptune, New Jersey, United States, 07753
        • Hackensack Meridian Health - Jersey Shore University Medical Center
      • Red Bank, New Jersey, United States, 07701
        • Hackensack Meridian Health - Riverview Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients diagnosed with cancer of the thoracic (lung), hepatobiliary system (cholangiocarcinoma, pancreatic, liver) that will undergo a scheduled surgical procedure
  • Able to understand and sign the informed consent form
  • Willingness to participate in the study and comply with protocol requirements

Exclusion Criteria:

  • Unable to provide consent
  • Unable to participate at the discretion of the PI based on the ECOG survey (if ECOG >1). See section 5 and appendix 1 for details.
  • Non- English speaking patients .
  • Opioid use for non-malignant pain for greater than 7 days 6 Terminal or Stage 4 cancer.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study arm - PREP Intervention
Participants receiving the coaching intervention
Behavioral: Personal Resilience Empowerment Program including 5 sessions with health coaches
5 coaching sessions that will take place either in-person or over the phone with a research nurse (RN)-Health Coach. During the sessions, the health coach will focus on introducing the 5 pillars of health and well-being: sleep, activity, purpose, nutrition and resilience. Will introduce breathing techniques participants and will teach patients how to acquire mind-body skills to assist in stress management, learn to thrive by building resilience, feel empowered to manage their health, gain self-care skills to decrease anxiety, pain and nausea naturally, control the stress response and trigger the relaxation response to promote well-being and discover what foods fuel the body in preparation for healing, during recovery and overall health.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Quality of Life Post Intervention (Coaching Sessions) - Sleep
Time Frame: Within two weeks from discharge, following the the post-operative visit (during the same day they would have the post-op visit, last coaching session and the post-intervention survey)

Quality of life concerning sleep (on 1-5 Likert scale with 1 being the worst and 5 the best in each category) developed for this project.

Change between the pre and the post intervention survey
Within two weeks from discharge, following the the post-operative visit (during the same day they would have the post-op visit, last coaching session and the post-intervention survey)
Change in Quality of Life Post Intervention (Coaching Sessions) - Activity
Time Frame: Within two weeks from discharge, following the the post-operative visit (during the same day they would have the post-op visit, last coaching session and the post-intervention survey)

Quality of life concerning activity (on 1-5 Likert scale with 1 being the worst and 5 the best in each category) developed for this project.

Change between the pre and the post intervention survey
Within two weeks from discharge, following the the post-operative visit (during the same day they would have the post-op visit, last coaching session and the post-intervention survey)
Change in Quality of Life Post Intervention (Coaching Sessions) - Purpose
Time Frame: Within two weeks from discharge, following the the post-operative visit (during the same day they would have the post-op visit, last coaching session and the post-intervention survey)

Quality of life concerning feeling of purpose (on 1-5 Likert scale with 1 being the worst and 5 the best in each category) developed for this project.

Change between the pre and the post intervention survey
Within two weeks from discharge, following the the post-operative visit (during the same day they would have the post-op visit, last coaching session and the post-intervention survey)
Change in Quality of Life Post Intervention (Coaching Sessions) - Nutrition
Time Frame: Within two weeks from discharge, following the the post-operative visit (during the same day they would have the post-op visit, last coaching session and the post-intervention survey)

Quality of life concerning nutrition (on 1-5 Likert scale with 1 being the worst and 5 the best in each category) developed for this project.

Change between the pre and the post intervention survey
Within two weeks from discharge, following the the post-operative visit (during the same day they would have the post-op visit, last coaching session and the post-intervention survey)
Change in Quality of Life Post Intervention (Coaching Sessions) - Sleep
Time Frame: At 1 month Post intervention (survey was sent at 30 days after the last couching session)

Quality of life concerning sleep (on 1-5 Likert scale with 1 being the worst and 5 the best in each category) developed for this project.

Change between the pre-intervention survey and 1-month post intervention survey
At 1 month Post intervention (survey was sent at 30 days after the last couching session)
Change in Quality of Life Post Intervention (Coaching Sessions) - Activity
Time Frame: At 1 month Post intervention (survey was sent at 30 days after the last couching session)

Quality of life concerning activity (on 1-5 Likert scale with 1 being the worst and 5 the best in each category) developed for this project.

Change between the pre and the 1-month post intervention survey
At 1 month Post intervention (survey was sent at 30 days after the last couching session)
Change in Quality of Life Post Intervention (Coaching Sessions) - Purpose
Time Frame: At 1 month Post intervention (survey was sent at 30 days after the last couching session)

Quality of life concerning feeling of purpose (on 1-5 Likert scale with 1 being the worst and 5 the best in each category) developed for this project.

Change between the pre and the 1-month post intervention survey
At 1 month Post intervention (survey was sent at 30 days after the last couching session)
Change in Quality of Life Post Intervention (Coaching Sessions) - Nutrition
Time Frame: At 1 month Post intervention (survey was sent at 30 days after the last couching session)

Quality of life concerning nutrition (on 1-5 Likert scale with 1 being the worst and 5 the best in each category) developed for this project.

Change between the pre and the 1-month post intervention survey
At 1 month Post intervention (survey was sent at 30 days after the last couching session)
Change in Quality of Life Post Intervention (Coaching Sessions) - Sleep
Time Frame: At 3 month Post intervention (survey was sent at 90 days after the last couching session)

Quality of life concerning sleep (on 1-5 Likert scale with 1 being the worst and 5 the best in each category) developed for this project.

Change between the pre-intervention survey and 3-month post intervention survey
At 3 month Post intervention (survey was sent at 90 days after the last couching session)
Change in Quality of Life Post Intervention (Coaching Sessions) - Activity
Time Frame: At 3 month Post intervention (survey was sent at 90 days after the last couching session)

Quality of life concerning activity (on 1-5 Likert scale with 1 being the worst and 5 the best in each category) developed for this project.

Change between the pre and the 3-month post intervention survey
At 3 month Post intervention (survey was sent at 90 days after the last couching session)
Change in Quality of Life Post Intervention (Coaching Sessions) - Purpose
Time Frame: At 3 month Post intervention (survey was sent at 90 days after the last couching session)

Quality of life concerning feeling of purpose (on 1-5 Likert scale with 1 being the worst and 5 the best in each category) developed for this project.

Change between the pre and the 3-month post intervention survey
At 3 month Post intervention (survey was sent at 90 days after the last couching session)
Change in Quality of Life Post Intervention (Coaching Sessions) - Nutrition
Time Frame: At 3 month Post intervention (survey was sent at 90 days after the last couching session)

Quality of life concerning nutrition (on 1-5 Likert scale with 1 being the worst and 5 the best in each category) developed for this project.

Change between the pre and the 3-month post intervention survey
At 3 month Post intervention (survey was sent at 90 days after the last couching session)
Change in Quality of Life Post Intervention (Coaching Sessions) - Resilience
Time Frame: Post intervention (survey completed at the end of last coaching session)

Quality of life concerning resilience (on 1-5 Likert scale with 1 being the worst and 5 the best in each category) developed for this project.

Change between the pre and the post intervention survey
Post intervention (survey completed at the end of last coaching session)
Change in Quality of Life Post Intervention (Coaching Sessions) - Resilience
Time Frame: At 1 month Post intervention (survey was sent at 30 days after the last couching session)

Quality of life concerning resilience (on 1-5 Likert scale with 1 being the worst and 5 the best in each category) developed for this project.

Change between the pre and the 1-month post intervention survey
At 1 month Post intervention (survey was sent at 30 days after the last couching session)
Change in Quality of Life Post Intervention (Coaching Sessions) - Resilience
Time Frame: At 3 month Post intervention (survey was sent at 90 days after the last couching session)

Quality of life concerning resilience (on 1-5 Likert scale with 1 being the worst and 5 the best in each category) developed for this project.

Change between the pre and the 3-month post intervention survey
At 3 month Post intervention (survey was sent at 90 days after the last couching session)
Change in Quality of Life Post Intervention (Coaching Sessions) - Empowerment
Time Frame: Post intervention (survey completed at the end of last coaching session)

Quality of life concerning Empowerment (on 1-5 Likert scale with 1 being the worst and 5 the best in each category) developed for this project.

Change between the pre and the post intervention survey
Post intervention (survey completed at the end of last coaching session)
Change in Quality of Life Post Intervention (Coaching Sessions) - Empowerment
Time Frame: At 1 month Post intervention (survey was sent at 30 days after the last couching session)

Quality of life concerning Empowerment (on 1-5 Likert scale with 1 being the worst and 5 the best in each category) developed for this project.

Change between the pre and the 1-month post intervention survey
At 1 month Post intervention (survey was sent at 30 days after the last couching session)
Change in Quality of Life Post Intervention (Coaching Sessions) - Empowerment
Time Frame: At 3 month Post intervention (survey was sent at 90 days after the last couching session)

Quality of life concerning Empowerment (on 1-5 Likert scale with 1 being the worst and 5 the best in each category) developed for this project.

Change between the pre and the 3-month post intervention survey
At 3 month Post intervention (survey was sent at 90 days after the last couching session)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hackensack Meridian Health

Investigators

  • Principal Investigator: Ronald Matteotti, MD, Hackensack Meridian Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 30, 2018

Primary Completion (Actual)

June 14, 2021

Study Completion (Actual)

June 14, 2021

Study Registration Dates

First Submitted

August 20, 2018

First Submitted That Met QC Criteria

August 21, 2018

First Posted (Actual)

August 23, 2018

Study Record Updates

Last Update Posted (Actual)

October 15, 2021

Last Update Submitted That Met QC Criteria

September 20, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB#201801121J

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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