Cholangiocarcinoma, Liver Cancer, Lung Cancer, Pancreatic Cancer
Conditions
Keywords
integrative medicine, cancer patients
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).
Interventions
BEHAVIORALPersonal 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.
Sponsors
Hackensack Meridian Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Quality of Life Post Intervention (Coaching Sessions) - Sleep | 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 |
| Change in Quality of Life Post Intervention (Coaching Sessions) - Activity | 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 |
| Change in Quality of Life Post Intervention (Coaching Sessions) - Purpose | 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 |
| Change in Quality of Life Post Intervention (Coaching Sessions) - Nutrition | 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 |
| Change in Quality of Life Post Intervention (Coaching Sessions) - Resilience | 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 |
| Change in Quality of Life Post Intervention (Coaching Sessions) - Empowerment | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Personal Resilience Empowerment Program Participants who were enrolled and attended at least one visit | 16 |
| Total | 16 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Participants at Last Visit (Pre-surveys) | Lost to Follow-up | 21 |
| Participants at the 1-month Follow up | Death | 2 |
| Participants at the 1-month Follow up | Lost to Follow-up | 2 |
| Participants at the 3-month Follow up | Lost to Follow-up | 2 |
Baseline characteristics
| Characteristic | Personal Resilience Empowerment Program |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 10 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants |
| Age, Continuous | 67.68 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 15 Participants |
| Region of Enrollment United States | 16 participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 2 / 16 |
| other Total, other adverse events | 0 / 10 | 0 / 16 |
| serious Total, serious adverse events | 0 / 10 | 2 / 16 |
Outcome results
Primary
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)
Population: Change in the question regarding activity (t-test) between the pre and the post intervention survey
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Personal Resilience Empowerment Program | Change in Quality of Life Post Intervention (Coaching Sessions) - Activity | Remaining physically active | 0.67 scores on a scale | Standard Deviation 1.23 |
| Personal Resilience Empowerment Program | Change in Quality of Life Post Intervention (Coaching Sessions) - Activity | Needing help with everyday activities | -0.08 scores on a scale | Standard Deviation 1.73 |
Primary
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)
Population: Change in the question regarding activity (t-test) between the pre and the post intervention survey
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Personal Resilience Empowerment Program | Change in Quality of Life Post Intervention (Coaching Sessions) - Activity | Remaining physically active | -0.13 scores on a scale | Standard Deviation 1.78 |
| Personal Resilience Empowerment Program | Change in Quality of Life Post Intervention (Coaching Sessions) - Activity | Needing help with everyday activities | 0.56 scores on a scale | Standard Deviation 1.9 |
Primary
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)
Population: Change in the question regarding activity (t-test) between the pre and the 3-month post intervention survey
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Personal Resilience Empowerment Program | Change in Quality of Life Post Intervention (Coaching Sessions) - Activity | Remaining physically active | 0.70 scores on a scale | Standard Deviation 0.95 |
| Personal Resilience Empowerment Program | Change in Quality of Life Post Intervention (Coaching Sessions) - Activity | Needing help with everyday activities | -0.80 scores on a scale | Standard Deviation 1.48 |
Primary
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)
Population: Change in the question regarding sleep (t-test) between the pre and the 1-month post intervention survey
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Personal Resilience Empowerment Program | Change in Quality of Life Post Intervention (Coaching Sessions) - Empowerment | Knowledge to manage own health | -0.20 scores on a scale | Standard Deviation 0.42 |
| Personal Resilience Empowerment Program | Change in Quality of Life Post Intervention (Coaching Sessions) - Empowerment | Being in control of own health and well-being | -0.40 scores on a scale | Standard Deviation 0.7 |
| Personal Resilience Empowerment Program | Change in Quality of Life Post Intervention (Coaching Sessions) - Empowerment | Knowing where to turn in times of crisis/stress | -0.22 scores on a scale | Standard Deviation 0.83 |
Primary
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)
Population: Change in the question regarding sleep (t-test) between the pre and the post intervention survey
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Personal Resilience Empowerment Program | Change in Quality of Life Post Intervention (Coaching Sessions) - Empowerment | Knowledge to manage own health | -0.13 scores on a scale | Standard Deviation 0.52 |
| Personal Resilience Empowerment Program | Change in Quality of Life Post Intervention (Coaching Sessions) - Empowerment | Being in control of own health and well-being | -0.25 scores on a scale | Standard Deviation 1.13 |
| Personal Resilience Empowerment Program | Change in Quality of Life Post Intervention (Coaching Sessions) - Empowerment | Knowing where to turn in times of crisis/stress | -0.13 scores on a scale | Standard Deviation 1.09 |
Primary
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)
Population: Change in the question regarding sleep (t-test) between the pre and the 1-month post intervention survey
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Personal Resilience Empowerment Program | Change in Quality of Life Post Intervention (Coaching Sessions) - Empowerment | Knowledge to manage own health | -0.33 scores on a scale | Standard Deviation 0.49 |
| Personal Resilience Empowerment Program | Change in Quality of Life Post Intervention (Coaching Sessions) - Empowerment | Being in control of own health and well-being | -0.33 scores on a scale | Standard Deviation 0.49 |
| Personal Resilience Empowerment Program | Change in Quality of Life Post Intervention (Coaching Sessions) - Empowerment | Knowing where to turn in times of crisis/stress | -0.25 scores on a scale | Standard Deviation 1.14 |
Primary
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)
Population: Change in the question regarding activity (t-test) between the pre and the post intervention survey
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Personal Resilience Empowerment Program | Change in Quality of Life Post Intervention (Coaching Sessions) - Nutrition | 5-10 servings of fruits/day | 0.45 scores on a scale | Standard Deviation 1.51 |
| Personal Resilience Empowerment Program | Change in Quality of Life Post Intervention (Coaching Sessions) - Nutrition | Avoiding fast food | 0.36 scores on a scale | Standard Deviation 1.96 |
Primary
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)
Population: Change in the question regarding activity (t-test) between the pre and the post intervention survey
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Personal Resilience Empowerment Program | Change in Quality of Life Post Intervention (Coaching Sessions) - Nutrition | 5-10 servings of fruits/day | 0.60 scores on a scale | Standard Deviation 1.4 |
| Personal Resilience Empowerment Program | Change in Quality of Life Post Intervention (Coaching Sessions) - Nutrition | Avoiding fast food | 1.00 scores on a scale | Standard Deviation 1.56 |
Primary
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)
Population: Change in the question regarding activity (t-test) between the pre and the 3- month post intervention survey
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Personal Resilience Empowerment Program | Change in Quality of Life Post Intervention (Coaching Sessions) - Nutrition | 5-10 servings of fruits/day | 0.44 scores on a scale | Standard Deviation 1.81 |
| Personal Resilience Empowerment Program | Change in Quality of Life Post Intervention (Coaching Sessions) - Nutrition | Avoiding fast food | 0.89 scores on a scale | Standard Deviation 2.42 |
Primary
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)
Population: Change in the question regarding activity (t-test) between the pre and the post intervention survey
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Personal Resilience Empowerment Program | Change in Quality of Life Post Intervention (Coaching Sessions) - Purpose | -0.33 scores on a scale | Standard Deviation 0.89 |
Primary
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)
Population: Change in the question regarding activity (t-test) between the pre and the post intervention survey
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Personal Resilience Empowerment Program | Change in Quality of Life Post Intervention (Coaching Sessions) - Purpose | -0.19 scores on a scale | Standard Deviation 0.66 |
Primary
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)
Population: Change in the question regarding activity (t-test) between the pre and the 3- month post intervention survey
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Personal Resilience Empowerment Program | Change in Quality of Life Post Intervention (Coaching Sessions) - Purpose | -0.22 scores on a scale | Standard Deviation 0.44 |
Primary
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)
Population: Change in the question regarding sleep (t-test) between the pre and the post intervention survey
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Personal Resilience Empowerment Program | Change in Quality of Life Post Intervention (Coaching Sessions) - Resilience | Adapting to changes | 0.00 scores on a scale | Standard Deviation 0.63 |
| Personal Resilience Empowerment Program | Change in Quality of Life Post Intervention (Coaching Sessions) - Resilience | Bouncing back from illness/injury and hardship | -0.13 scores on a scale | Standard Deviation 0.64 |
Primary
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)
Population: Change in the question regarding sleep (t-test) between the pre and the post intervention survey
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Personal Resilience Empowerment Program | Change in Quality of Life Post Intervention (Coaching Sessions) - Resilience | Adapting to changes | 0.00 scores on a scale | Standard Deviation 0.95 |
| Personal Resilience Empowerment Program | Change in Quality of Life Post Intervention (Coaching Sessions) - Resilience | Bouncing back from illness/injury and hardship | -0.36 scores on a scale | Standard Deviation 0.5 |
Primary
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)
Population: Change in the question regarding sleep (t-test) between the pre and the 3-month post intervention survey
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Personal Resilience Empowerment Program | Change in Quality of Life Post Intervention (Coaching Sessions) - Resilience | Adapting to changes | 0.00 scores on a scale | Standard Deviation 0.87 |
| Personal Resilience Empowerment Program | Change in Quality of Life Post Intervention (Coaching Sessions) - Resilience | Bouncing back from illness/injury and hardship | -0.11 scores on a scale | Standard Deviation 0.33 |
Primary
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)
Population: Change in the question regarding sleep (t-test) between the pre and the post intervention survey
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Personal Resilience Empowerment Program | Change in Quality of Life Post Intervention (Coaching Sessions) - Sleep | 7-8 hours of sleep/day | -1.06 scores on a scale | Standard Deviation 1.95 |
| Personal Resilience Empowerment Program | Change in Quality of Life Post Intervention (Coaching Sessions) - Sleep | Waking up rested | -0.80 scores on a scale | Standard Deviation 1.97 |
Primary
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)
Population: Change in the question regarding sleep (t-test) between the pre and the 1-month post intervention survey
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Personal Resilience Empowerment Program | Change in Quality of Life Post Intervention (Coaching Sessions) - Sleep | 7-8 hours of sleep/day | -0.33 scores on a scale | Standard Deviation 1.23 |
| Personal Resilience Empowerment Program | Change in Quality of Life Post Intervention (Coaching Sessions) - Sleep | Waking up rested | 0.08 scores on a scale | Standard Deviation 1.16 |
Primary
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)
Population: Change in the question regarding sleep (t-test) between the pre and the 3-month post intervention survey
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Personal Resilience Empowerment Program | Change in Quality of Life Post Intervention (Coaching Sessions) - Sleep | 7-8 hours of sleep/day | -0.63 scores on a scale | Standard Deviation 1.51 |
| Personal Resilience Empowerment Program | Change in Quality of Life Post Intervention (Coaching Sessions) - Sleep | Waking up rested | -0.80 scores on a scale | Standard Deviation 1.55 |