Brief Title
Personal Resilience Empowerment Program Study
Official Title
Personal Resilience Empowerment Program (PREP) in the Perioperative Setting of Surgically Treated Cancer Patients
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).
Study Type
Interventional
Primary Outcome
Change in Quality of Life Post Intervention (Coaching Sessions) - Sleep
Condition
Lung Cancer
Intervention
Personal Resilience Empowerment Program including 5 sessions with health coaches
Study Arms / Comparison Groups
Study arm - PREP Intervention
Description: Participants receiving the coaching intervention
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Behavioral
Estimated Enrollment
37
Start Date
May 30, 2018
Completion Date
June 14, 2021
Primary Completion Date
June 14, 2021
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.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Ronald Matteotti, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT03644173
Organization ID
IRB#201801121J
Responsible Party
Sponsor
Study Sponsor
Hackensack Meridian Health
Study Sponsor
Ronald Matteotti, MD, Principal Investigator, Hackensack Meridian Health
Verification Date
September 2021