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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study arm - PREP Intervention | Experimental | Participants receiving the coaching intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ronald Matteotti, MD | Hackensack Meridian Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hackensack Meridian Health - Jersey Shore University Medical Center | Neptune City | New Jersey | 07753 | United States | ||
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| ID | Title | Description |
|---|---|---|
| FG000 | Personal Resilience Empowerment Program | Participants who were enrolled and completed all visits |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Participants at Last Visit (Pre-surveys) |
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| Participants at the 1-month Follow up |
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| Participants at the 3-month Follow up |
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Participants who completed the visits (even if they did not complete the follow-up surveys)
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| ID | Title | Description |
|---|---|---|
| BG000 | Personal Resilience Empowerment Program | Participants who were enrolled and attended at least one visit |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Change in the question regarding sleep (t-test) between the pre and the post intervention survey | Posted | Mean | Standard Deviation | scores on a scale | 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) |
|
3 months post-op
Any adverse events related to the Personal Resilience Empowerment Program Study
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Personal Resilience Empowerment Program (All Visits and Follow up) | Participants who were enrolled, completed all visits and completed the two follow-up visits (1 month and 3 months post-op) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death due to underlining cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment | Unrelated to the Personal Resilience Empowerment Program Study |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Manager, Investigator Initiated Research Program | Hackensack meridian Health | 5519961244 | Elli.GournaPaleoudis@hmhn.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 19, 2018 | Jun 30, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D018281 | Cholangiocarcinoma |
| D010190 | Pancreatic Neoplasms |
| D008113 | Liver Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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|
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) |
| Hackensack Meridian Health - Riverview Medical Center |
| Red Bank |
| New Jersey |
| 07701 |
| United States |
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| Participants |
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| Age, Continuous | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units | Counts |
|---|---|
| Participants |
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| 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 | Change in the question regarding activity (t-test) between the pre and the post intervention survey | Posted | Mean | Standard Deviation | scores on a scale | 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) |
|
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| 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 | Change in the question regarding activity (t-test) between the pre and the post intervention survey | Posted | Mean | Standard Deviation | scores on a scale | 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) |
|
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| 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 | Change in the question regarding activity (t-test) between the pre and the post intervention survey | Posted | Mean | Standard Deviation | scores on a scale | 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) |
|
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| 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 | Change in the question regarding sleep (t-test) between the pre and the 1-month post intervention survey | Posted | Mean | Standard Deviation | scores on a scale | At 1 month Post intervention (survey was sent at 30 days after the last couching session) |
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| 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 | Change in the question regarding activity (t-test) between the pre and the post intervention survey | Posted | Mean | Standard Deviation | scores on a scale | At 1 month Post intervention (survey was sent at 30 days after the last couching session) |
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| 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 | Change in the question regarding activity (t-test) between the pre and the post intervention survey | Posted | Mean | Standard Deviation | scores on a scale | At 1 month Post intervention (survey was sent at 30 days after the last couching session) |
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| 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 | Change in the question regarding activity (t-test) between the pre and the post intervention survey | Posted | Mean | Standard Deviation | scores on a scale | At 1 month Post intervention (survey was sent at 30 days after the last couching session) |
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| 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 | Change in the question regarding sleep (t-test) between the pre and the 3-month post intervention survey | Posted | Mean | Standard Deviation | scores on a scale | At 3 month Post intervention (survey was sent at 90 days after the last couching session) |
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| 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 | Change in the question regarding activity (t-test) between the pre and the 3-month post intervention survey | Posted | Mean | Standard Deviation | scores on a scale | At 3 month Post intervention (survey was sent at 90 days after the last couching session) |
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| 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 | Change in the question regarding activity (t-test) between the pre and the 3- month post intervention survey | Posted | Mean | Standard Deviation | scores on a scale | At 3 month Post intervention (survey was sent at 90 days after the last couching session) |
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| 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 | Change in the question regarding activity (t-test) between the pre and the 3- month post intervention survey | Posted | Mean | Standard Deviation | scores on a scale | At 3 month Post intervention (survey was sent at 90 days after the last couching session) |
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| 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 | Change in the question regarding sleep (t-test) between the pre and the post intervention survey | Posted | Mean | Standard Deviation | scores on a scale | Post intervention (survey completed at the end of last coaching session) |
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| 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 | Change in the question regarding sleep (t-test) between the pre and the post intervention survey | Posted | Mean | Standard Deviation | scores on a scale | At 1 month Post intervention (survey was sent at 30 days after the last couching session) |
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| 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 | Change in the question regarding sleep (t-test) between the pre and the 3-month post intervention survey | Posted | Mean | Standard Deviation | scores on a scale | At 3 month Post intervention (survey was sent at 90 days after the last couching session) |
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| 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 | Change in the question regarding sleep (t-test) between the pre and the post intervention survey | Posted | Mean | Standard Deviation | scores on a scale | Post intervention (survey completed at the end of last coaching session) |
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| 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 | Change in the question regarding sleep (t-test) between the pre and the 1-month post intervention survey | Posted | Mean | Standard Deviation | scores on a scale | At 1 month Post intervention (survey was sent at 30 days after the last couching session) |
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| 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 | Change in the question regarding sleep (t-test) between the pre and the 1-month post intervention survey | Posted | Mean | Standard Deviation | scores on a scale | At 3 month Post intervention (survey was sent at 90 days after the last couching session) |
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| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Personal Resilience Empowerment Program (Visits Only) | Participants who were enrolled and completed the first three visits (but not follow-up) | 2 | 16 | 2 | 16 | 0 | 16 |
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| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D004067 | Digestive System Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D008107 | Liver Diseases |
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| Knowing where to turn in times of crisis/stress |
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| Knowing where to turn in times of crisis/stress |
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