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Completed

NCT Number: NCT03644173

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).

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Key information

Conditions

Lung Cancer Adenocarcinoma Carcinoma Cholangiocarcinoma Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Liver Cancer Liver Diseases Liver Neoplasms Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Pancreatic Cancer Pancreatic Diseases Pancreatic Neoplasms Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hackensack Meridian Health - Jersey Shore University Medical Center, Neptune City, New Jersey, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Personal Resilience Empowerment Program including 5 sessions with health coaches

Behavioral

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 outcomes

  1. Change in Quality of Life Post Intervention (Coaching Sessions) - Sleep

    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)

    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

  2. Change in Quality of Life Post Intervention (Coaching Sessions) - Activity

    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)

    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

  3. Change in Quality of Life Post Intervention (Coaching Sessions) - Purpose

    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)

    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

  4. Change in Quality of Life Post Intervention (Coaching Sessions) - Nutrition

    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)

    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

  5. Change in Quality of Life Post Intervention (Coaching Sessions) - Sleep

    Time frame: At 1 month Post intervention (survey was sent at 30 days after the last couching session)

    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

  6. Change in Quality of Life Post Intervention (Coaching Sessions) - Activity

    Time frame: At 1 month Post intervention (survey was sent at 30 days after the last couching session)

    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

  7. Change in Quality of Life Post Intervention (Coaching Sessions) - Purpose

    Time frame: At 1 month Post intervention (survey was sent at 30 days after the last couching session)

    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

  8. Change in Quality of Life Post Intervention (Coaching Sessions) - Nutrition

    Time frame: At 1 month Post intervention (survey was sent at 30 days after the last couching session)

    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

  9. Change in Quality of Life Post Intervention (Coaching Sessions) - Sleep

    Time frame: At 3 month Post intervention (survey was sent at 90 days after the last couching session)

    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

  10. Change in Quality of Life Post Intervention (Coaching Sessions) - Activity

    Time frame: At 3 month Post intervention (survey was sent at 90 days after the last couching session)

    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

  11. Change in Quality of Life Post Intervention (Coaching Sessions) - Purpose

    Time frame: At 3 month Post intervention (survey was sent at 90 days after the last couching session)

    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

  12. Change in Quality of Life Post Intervention (Coaching Sessions) - Nutrition

    Time frame: At 3 month Post intervention (survey was sent at 90 days after the last couching session)

    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

  13. Change in Quality of Life Post Intervention (Coaching Sessions) - Resilience

    Time frame: Post intervention (survey completed at the end of last coaching session)

    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

  14. Change in Quality of Life Post Intervention (Coaching Sessions) - Resilience

    Time frame: At 1 month Post intervention (survey was sent at 30 days after the last couching session)

    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

  15. Change in Quality of Life Post Intervention (Coaching Sessions) - Resilience

    Time frame: At 3 month Post intervention (survey was sent at 90 days after the last couching session)

    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

  16. Change in Quality of Life Post Intervention (Coaching Sessions) - Empowerment

    Time frame: Post intervention (survey completed at the end of last coaching session)

    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

  17. Change in Quality of Life Post Intervention (Coaching Sessions) - Empowerment

    Time frame: At 1 month Post intervention (survey was sent at 30 days after the last couching session)

    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

  18. Change in Quality of Life Post Intervention (Coaching Sessions) - Empowerment

    Time frame: At 3 month Post intervention (survey was sent at 90 days after the last couching session)

    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

Sponsors and collaborators

Lead sponsor

Hackensack Meridian Health

Other

Registry information

Official study title

Personal Resilience Empowerment Program (PREP) in the Perioperative Setting of Surgically Treated Cancer Patients

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Aug 23, 2018
Registry last updated
Oct 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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