Personal Resilience Empowerment Program Study

Study Overview
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Brief Summary
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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).

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

Conditions
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Lung Cancer, Cholangiocarcinoma, Pancreatic Cancer, Liver Cancer

Intervention / Treatment
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* Behavioral: Personal Resilience Empowerment Program including 5 sessions with health coaches


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study arm - PREP Intervention<br>Participants receiving the coaching intervention | Behavioral: Personal Resilience Empowerment Program including 5 sessions with health coaches<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Quality of Life Post Intervention (Coaching Sessions) - Sleep | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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integrative medicine, cancer patients