N/A
N=37
Personal Resilience Empowerment Program Study
Lung Cancer · Cholangiocarcinoma · Pancreatic Cancer · Liver Cancer
Bottom Line
View on ClinicalTrials.gov: NCT03644173 ↗Enrolled (actual)
37
Serious AEs
7.7%
Results posted
Oct 2021
Primary outcome: Primary: Change in Quality of Life Post Intervention (Coaching Sessions) - Sleep — -1.06; -0.80 scores on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Personal Resilience Empowerment Program including 5 sessions with health coaches (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hackensack Meridian Health
- Primary completion
- Jun 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Quality of Life Post Intervention (Coaching Sessions) - Sleep |
-0.63; -0.80 | — |
| PRIMARY Change in Quality of Life Post Intervention (Coaching Sessions) - Activity |
0.70; -0.80 | — |
| PRIMARY Change in Quality of Life Post Intervention (Coaching Sessions) - Purpose |
-0.22 | — |
| PRIMARY Change in Quality of Life Post Intervention (Coaching Sessions) - Nutrition |
0.44; 0.89 | — |
| PRIMARY Change in Quality of Life Post Intervention (Coaching Sessions) - Sleep |
-0.63; -0.80 | — |
| PRIMARY Change in Quality of Life Post Intervention (Coaching Sessions) - Activity |
0.70; -0.80 | — |
| PRIMARY Change in Quality of Life Post Intervention (Coaching Sessions) - Purpose |
-0.22 | — |
| PRIMARY Change in Quality of Life Post Intervention (Coaching Sessions) - Nutrition |
0.44; 0.89 | — |
| PRIMARY Change in Quality of Life Post Intervention (Coaching Sessions) - Sleep |
-0.63; -0.80 | — |
| PRIMARY Change in Quality of Life Post Intervention (Coaching Sessions) - Activity |
0.70; -0.80 | — |
| PRIMARY Change in Quality of Life Post Intervention (Coaching Sessions) - Purpose |
-0.22 | — |
| PRIMARY Change in Quality of Life Post Intervention (Coaching Sessions) - Nutrition |
0.44; 0.89 | — |
| PRIMARY Change in Quality of Life Post Intervention (Coaching Sessions) - Resilience |
0.00; -0.11 | — |
| PRIMARY Change in Quality of Life Post Intervention (Coaching Sessions) - Resilience |
0.00; -0.11 | — |
| PRIMARY Change in Quality of Life Post Intervention (Coaching Sessions) - Resilience |
0.00; -0.11 | — |
| PRIMARY Change in Quality of Life Post Intervention (Coaching Sessions) - Empowerment |
-0.20; -0.40; -0.22 | — |
| PRIMARY Change in Quality of Life Post Intervention (Coaching Sessions) - Empowerment |
-0.20; -0.40; -0.22 | — |
| PRIMARY Change in Quality of Life Post Intervention (Coaching Sessions) - Empowerment |
-0.20; -0.40; -0.22 | — |
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).
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.
Data sourced from ClinicalTrials.gov (NCT03644173). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.