2018-05-30
2021-06-14
2021-06-14
37
NCT03644173
Hackensack Meridian Health
Hackensack Meridian Health
INTERVENTIONAL
Personal Resilience Empowerment Program Study
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).
N/A
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 Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2018-08-20 | 2021-06-30 | 2021-09-20 |
2018-08-21 | 2021-09-20 | 2021-10-15 |
2018-08-23 | 2021-10-15 | 2021-09 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Supportive Care
Allocation:
Na
Interventional Model:
Single Group
Masking:
None
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
|
| Primary Outcome Measures | 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) |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
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.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
NPCF was founded on May 29, 2009 and is a 501(c)(3) organization. All donations are tax deductible.
The information and services provided by the National Pancreatic Cancer Foundation are for informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnosis or treatment. The National Pancreatic Cancer Foundation does not recommend nor endorse any specific physicians, products or treatments even though they may be mentioned on this site.
Copyright © 2024 – National Pancreatic Cancer Foundation | All Rights Reserved
