NCT03644173

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable lung-cancer

Timeline
Completed

Started May 2018

Typical duration for not_applicable lung-cancer

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 30, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 20, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 23, 2018

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 14, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 14, 2021

Completed
4 months until next milestone

Results Posted

Study results publicly available

October 15, 2021

Completed
Last Updated

October 15, 2021

Status Verified

September 1, 2021

Enrollment Period

3 years

First QC Date

August 20, 2018

Results QC Date

June 30, 2021

Last Update Submit

September 20, 2021

Conditions

Lung CancerCholangiocarcinomaPancreatic CancerLiver Cancer

Keywords

integrative medicinecancer patients

Outcome Measures

Primary Outcomes (18)

  • 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)

Study Arms (1)

Study arm - PREP Intervention

EXPERIMENTAL

Participants receiving the coaching intervention

Behavioral: Personal Resilience Empowerment Program including 5 sessions with health coaches

Interventions

Personal Resilience Empowerment Program including 5 sessions with health coachesBEHAVIORAL

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.

Study arm - PREP Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hackensack Meridian Health - Jersey Shore University Medical Center

Neptune City, New Jersey, 07753, United States

Location

Hackensack Meridian Health - Riverview Medical Center

Red Bank, New Jersey, 07701, United States

Location

MeSH Terms

Conditions

Lung NeoplasmsCholangiocarcinomaPancreatic NeoplasmsLiver Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeDigestive System NeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesLiver Diseases

Results Point of Contact

Title
Manager, Investigator Initiated Research Program
Organization
Hackensack meridian Health
Elli.GournaPaleoudis@hmhn.org
5519961244

Study Officials

  • Ronald Matteotti, MD

    Hackensack Meridian Health

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 20, 2018

First Posted

August 23, 2018

Study Start

May 30, 2018

Primary Completion

June 14, 2021

Study Completion

June 14, 2021

Last Updated

October 15, 2021

Results First Posted

October 15, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

US(2)