An interventional study of Personal Resilience Empowerment Program including 5 sessions with health coaches in Lung Cancer, Cholangiocarcinoma and Pancreatic Cancer, sponsored by Hackensack Meridian Health. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-10-15.
Sponsored by Hackensack Meridian Health · Not applicable, Interventional, and Supportive care
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).
914 studies on the registry are indexed under Cholangiocarcinoma; 286 are open to participants now.
This study's enrollment of 37 is below the median of 50 across 687 interventional studies indexed under Cholangiocarcinoma.
Browse Cholangiocarcinoma studies →Hackensack Meridian Health is the lead sponsor of 111 studies on the registry; 28 are open to participants now.
Of its 16 completed or terminated interventional studies of FDA-regulated products, 11 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants receiving the coaching intervention
Behavioral: 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.
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
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)
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
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)
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
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)
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
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)
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: At 3 month Post intervention (survey was sent at 90 days after the last couching session)
| Milestone | Personal Resilience Empowerment Program |
|---|---|
| Started | 37 |
| Completed | 16 |
| Not completed | 21 |
| Withdrew: Lost to follow-up | 21 |
| Milestone | Personal Resilience Empowerment Program |
|---|---|
| Started | 16 |
| Completed | 12 |
| Not completed | 4 |
| Withdrew: Lost to follow-up | 2 |
| Withdrew: Death | 2 |
| Milestone | Personal Resilience Empowerment Program |
|---|---|
| Started | 12 |
| Completed | 10 |
| Not completed | 2 |
| Withdrew: Lost to follow-up | 2 |
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
| scores on a scale | Personal Resilience Empowerment Program |
|---|---|
| 7-8 hours of sleep/day | -1.06 ± 1.95 |
| Waking up rested | -0.80 ± 1.97 |
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
| scores on a scale | Personal Resilience Empowerment Program |
|---|---|
| Remaining physically active | -0.13 ± 1.78 |
| Needing help with everyday activities | 0.56 ± 1.90 |
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
| scores on a scale | Personal Resilience Empowerment Program |
|---|---|
| Change in Quality of Life Post Intervention (Coaching Sessions) - Purpose | -0.19 ± 0.66 |
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
| scores on a scale | Personal Resilience Empowerment Program |
|---|---|
| 5-10 servings of fruits/day | 0.60 ± 1.40 |
| Avoiding fast food | 1.00 ± 1.56 |
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
| scores on a scale | Personal Resilience Empowerment Program |
|---|---|
| 7-8 hours of sleep/day | -0.33 ± 1.23 |
| Waking up rested | 0.08 ± 1.16 |
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
| scores on a scale | Personal Resilience Empowerment Program |
|---|---|
| Remaining physically active | 0.67 ± 1.23 |
| Needing help with everyday activities | -0.08 ± 1.73 |
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
| scores on a scale | Personal Resilience Empowerment Program |
|---|---|
| Change in Quality of Life Post Intervention (Coaching Sessions) - Purpose | -0.33 ± 0.89 |
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
| scores on a scale | Personal Resilience Empowerment Program |
|---|---|
| 5-10 servings of fruits/day | 0.45 ± 1.51 |
| Avoiding fast food | 0.36 ± 1.96 |
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
| scores on a scale | Personal Resilience Empowerment Program |
|---|---|
| 7-8 hours of sleep/day | -0.63 ± 1.51 |
| Waking up rested | -0.80 ± 1.55 |
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
| scores on a scale | Personal Resilience Empowerment Program |
|---|---|
| Remaining physically active | 0.70 ± 0.95 |
| Needing help with everyday activities | -0.80 ± 1.48 |
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
| scores on a scale | Personal Resilience Empowerment Program |
|---|---|
| Change in Quality of Life Post Intervention (Coaching Sessions) - Purpose | -0.22 ± 0.44 |
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
| scores on a scale | Personal Resilience Empowerment Program |
|---|---|
| 5-10 servings of fruits/day | 0.44 ± 1.81 |
| Avoiding fast food | 0.89 ± 2.42 |
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
| scores on a scale | Personal Resilience Empowerment Program |
|---|---|
| Adapting to changes | 0.00 ± 0.63 |
| Bouncing back from illness/injury and hardship | -0.13 ± 0.64 |
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
| scores on a scale | Personal Resilience Empowerment Program |
|---|---|
| Adapting to changes | 0.00 ± 0.95 |
| Bouncing back from illness/injury and hardship | -0.36 ± 0.50 |
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
| scores on a scale | Personal Resilience Empowerment Program |
|---|---|
| Adapting to changes | 0.00 ± 0.87 |
| Bouncing back from illness/injury and hardship | -0.11 ± 0.33 |
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
| scores on a scale | Personal Resilience Empowerment Program |
|---|---|
| Knowledge to manage own health | -0.13 ± 0.52 |
| Being in control of own health and well-being | -0.25 ± 1.13 |
| Knowing where to turn in times of crisis/stress | -0.13 ± 1.09 |
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
| scores on a scale | Personal Resilience Empowerment Program |
|---|---|
| Knowledge to manage own health | -0.33 ± 0.49 |
| Being in control of own health and well-being | -0.33 ± 0.49 |
| Knowing where to turn in times of crisis/stress | -0.25 ± 1.14 |
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
| scores on a scale | Personal Resilience Empowerment Program |
|---|---|
| Knowledge to manage own health | -0.20 ± 0.42 |
| Being in control of own health and well-being | -0.40 ± 0.70 |
| Knowing where to turn in times of crisis/stress | -0.22 ± 0.83 |
Collected over 3 months post-op. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Personal Resilience Empowerment Program (All Visits and Follow up) | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) |
| Personal Resilience Empowerment Program (Visits Only) | 2/16 (12.5%) | 2/16 (12.5%) | 0/16 (0%) |
| Event | Personal Resilience Empowerment Program (All Visits and Follow up) | Personal Resilience Empowerment Program (Visits Only) |
|---|---|---|
| Death due to underlining cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/10 | 2/16 |
Participants who completed the visits (even if they did not complete the follow-up surveys)
| Age, Categorical(Participants) | Personal Resilience Empowerment Program |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 6 |
| >=65 years | 10 |
| Age, Continuous(years) | Personal Resilience Empowerment Program |
|---|---|
| Mean | 67.68 (38 to 87) |
| Sex: Female, Male(Participants) | Personal Resilience Empowerment Program |
|---|---|
| Female | 5 |
| Male | 11 |
| Race (NIH/OMB)(Participants) | Personal Resilience Empowerment Program |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 1 |
| White | 15 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Personal Resilience Empowerment Program |
|---|---|
| United States | 16 |
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Hackensack Meridian Health