Personal Resilience Empowerment Program Study
Primary Purpose
Lung Cancer, Cholangiocarcinoma, Pancreatic Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Personal Resilience Empowerment Program including 5 sessions with health coaches
Sponsored by
About this trial
This is an interventional supportive care trial for Lung Cancer focused on measuring integrative medicine, cancer patients
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.
Sites / Locations
- Hackensack Meridian Health - Jersey Shore University Medical Center
- Hackensack Meridian Health - Riverview Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Study arm - PREP Intervention
Arm Description
Participants receiving the coaching intervention
Outcomes
Primary Outcome Measures
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Secondary Outcome Measures
Full Information
NCT ID
NCT03644173
First Posted
August 20, 2018
Last Updated
September 20, 2021
Sponsor
Hackensack Meridian Health
1. Study Identification
Unique Protocol Identification Number
NCT03644173
Brief Title
Personal Resilience Empowerment Program Study
Official Title
Personal Resilience Empowerment Program (PREP) in the Perioperative Setting of Surgically Treated Cancer Patients
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
May 30, 2018 (Actual)
Primary Completion Date
June 14, 2021 (Actual)
Study Completion Date
June 14, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hackensack Meridian Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Cholangiocarcinoma, Pancreatic Cancer, Liver Cancer
Keywords
integrative medicine, cancer patients
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Study arm - PREP Intervention
Arm Type
Experimental
Arm Description
Participants receiving the coaching intervention
Intervention Type
Behavioral
Intervention Name(s)
Personal Resilience Empowerment Program including 5 sessions with health coaches
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Quality of Life Post Intervention (Coaching Sessions) - Sleep
Description
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
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)
Title
Change in Quality of Life Post Intervention (Coaching Sessions) - Activity
Description
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
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)
Title
Change in Quality of Life Post Intervention (Coaching Sessions) - Purpose
Description
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
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)
Title
Change in Quality of Life Post Intervention (Coaching Sessions) - Nutrition
Description
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
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)
Title
Change in Quality of Life Post Intervention (Coaching Sessions) - Sleep
Description
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
Time Frame
At 1 month Post intervention (survey was sent at 30 days after the last couching session)
Title
Change in Quality of Life Post Intervention (Coaching Sessions) - Activity
Description
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
Time Frame
At 1 month Post intervention (survey was sent at 30 days after the last couching session)
Title
Change in Quality of Life Post Intervention (Coaching Sessions) - Purpose
Description
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
Time Frame
At 1 month Post intervention (survey was sent at 30 days after the last couching session)
Title
Change in Quality of Life Post Intervention (Coaching Sessions) - Nutrition
Description
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
Time Frame
At 1 month Post intervention (survey was sent at 30 days after the last couching session)
Title
Change in Quality of Life Post Intervention (Coaching Sessions) - Sleep
Description
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
Time Frame
At 3 month Post intervention (survey was sent at 90 days after the last couching session)
Title
Change in Quality of Life Post Intervention (Coaching Sessions) - Activity
Description
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
Time Frame
At 3 month Post intervention (survey was sent at 90 days after the last couching session)
Title
Change in Quality of Life Post Intervention (Coaching Sessions) - Purpose
Description
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
Time Frame
At 3 month Post intervention (survey was sent at 90 days after the last couching session)
Title
Change in Quality of Life Post Intervention (Coaching Sessions) - Nutrition
Description
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
Time Frame
At 3 month Post intervention (survey was sent at 90 days after the last couching session)
Title
Change in Quality of Life Post Intervention (Coaching Sessions) - Resilience
Description
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
Time Frame
Post intervention (survey completed at the end of last coaching session)
Title
Change in Quality of Life Post Intervention (Coaching Sessions) - Resilience
Description
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
Time Frame
At 1 month Post intervention (survey was sent at 30 days after the last couching session)
Title
Change in Quality of Life Post Intervention (Coaching Sessions) - Resilience
Description
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
Time Frame
At 3 month Post intervention (survey was sent at 90 days after the last couching session)
Title
Change in Quality of Life Post Intervention (Coaching Sessions) - Empowerment
Description
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
Time Frame
Post intervention (survey completed at the end of last coaching session)
Title
Change in Quality of Life Post Intervention (Coaching Sessions) - Empowerment
Description
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
Time Frame
At 1 month Post intervention (survey was sent at 30 days after the last couching session)
Title
Change in Quality of Life Post Intervention (Coaching Sessions) - Empowerment
Description
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
Time Frame
At 3 month Post intervention (survey was sent at 90 days after the last couching session)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald Matteotti, MD
Organizational Affiliation
Hackensack Meridian Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hackensack Meridian Health - Jersey Shore University Medical Center
City
Neptune
State/Province
New Jersey
ZIP/Postal Code
07753
Country
United States
Facility Name
Hackensack Meridian Health - Riverview Medical Center
City
Red Bank
State/Province
New Jersey
ZIP/Postal Code
07701
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Personal Resilience Empowerment Program Study
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