Clinical trial NCT03644173: Personal Resilience Empowerment Program Study
Official title: Personal Resilience Empowerment Program (PREP) in the Perioperative Setting of Surgically Treated Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Cholangiocarcinoma
Pancreatic Cancer
Liver Cancer
Keywords: integrative medicine
cancer patients
Lead sponsor: Hackensack Meridian Health
Sponsor class: OTHER
First posted: 2018-08-23
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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).


Eligibility criteria: 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.

Primary outcomes:
measure: Change in Quality of Life Post Intervention (Coaching Sessions) - Sleep
timeFrame: 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)
measure: Change in Quality of Life Post Intervention (Coaching Sessions) - Activity
timeFrame: 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)
measure: Change in Quality of Life Post Intervention (Coaching Sessions) - Purpose
timeFrame: 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)
measure: Change in Quality of Life Post Intervention (Coaching Sessions) - Nutrition
timeFrame: 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)
measure: Change in Quality of Life Post Intervention (Coaching Sessions) - Sleep
timeFrame: At 1 month Post intervention (survey was sent at 30 days after the last couching session)
measure: Change in Quality of Life Post Intervention (Coaching Sessions) - Activity
timeFrame: At 1 month Post intervention (survey was sent at 30 days after the last couching session)
measure: Change in Quality of Life Post Intervention (Coaching Sessions) - Purpose
timeFrame: At 1 month Post intervention (survey was sent at 30 days after the last couching session)
measure: Change in Quality of Life Post Intervention (Coaching Sessions) - Nutrition
timeFrame: At 1 month Post intervention (survey was sent at 30 days after the last couching session)
measure: Change in Quality of Life Post Intervention (Coaching Sessions) - Sleep
timeFrame: At 3 month Post intervention (survey was sent at 90 days after the last couching session)
measure: Change in Quality of Life Post Intervention (Coaching Sessions) - Activity
timeFrame: At 3 month Post intervention (survey was sent at 90 days after the last couching session)
measure: Change in Quality of Life Post Intervention (Coaching Sessions) - Purpose
timeFrame: At 3 month Post intervention (survey was sent at 90 days after the last couching session)
measure: Change in Quality of Life Post Intervention (Coaching Sessions) - Nutrition
timeFrame: At 3 month Post intervention (survey was sent at 90 days after the last couching session)
measure: Change in Quality of Life Post Intervention (Coaching Sessions) - Resilience
timeFrame: Post intervention (survey completed at the end of last coaching session)
measure: Change in Quality of Life Post Intervention (Coaching Sessions) - Resilience
timeFrame: At 1 month Post intervention (survey was sent at 30 days after the last couching session)
measure: Change in Quality of Life Post Intervention (Coaching Sessions) - Resilience
timeFrame: At 3 month Post intervention (survey was sent at 90 days after the last couching session)
measure: Change in Quality of Life Post Intervention (Coaching Sessions) - Empowerment
timeFrame: Post intervention (survey completed at the end of last coaching session)
measure: Change in Quality of Life Post Intervention (Coaching Sessions) - Empowerment
timeFrame: At 1 month Post intervention (survey was sent at 30 days after the last couching session)
measure: Change in Quality of Life Post Intervention (Coaching Sessions) - Empowerment
timeFrame: At 3 month Post intervention (survey was sent at 90 days after the last couching session)
Secondary outcomes:
Other outcomes:
Locations:
city: Neptune
country: United States
facility: Hackensack Meridian Health - Jersey Shore University Medical Center
state: New Jersey
city: Red Bank
country: United States
facility: Hackensack Meridian Health - Riverview Medical Center
state: New Jersey
Study officials:
affiliation: Hackensack Meridian Health
name: Ronald Matteotti, MD
role: PRINCIPAL_INVESTIGATOR
References: