Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
37 participants
INTERVENTIONAL
2018-05-30
2021-06-14
Brief Summary
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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).
Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Study arm - PREP Intervention
Participants receiving the coaching intervention
Personal Resilience Empowerment Program including 5 sessions with health coaches
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.
Interventions
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Personal Resilience Empowerment Program including 5 sessions with health coaches
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.
Eligibility Criteria
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Inclusion Criteria
* Able to understand and sign the informed consent form
* Willingness to participate in the study and comply with protocol requirements
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Hackensack Meridian Health
OTHER
Responsible Party
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Principal Investigators
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Ronald Matteotti, MD
Role: PRINCIPAL_INVESTIGATOR
Hackensack Meridian Health
Locations
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Hackensack Meridian Health - Jersey Shore University Medical Center
Neptune City, New Jersey, United States
Hackensack Meridian Health - Riverview Medical Center
Red Bank, New Jersey, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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IRB#201801121J
Identifier Type: -
Identifier Source: org_study_id