Personal Resilience Empowerment Program Study

• Sponsor: Hackensack Meridian Health (Other)
• Overall Status: Completed
• CT.gov ID: NCT03644173
• Collaborator: (none)
• Enrollment: 37
• Locations: 2
• Arm: 1
• Actual Duration (Months): 36.5
• Patients Per Site: 18.5
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Lung Cancer; Cholangiocarcinoma; Pancreatic Cancer; Liver Cancer	Behavioral: Personal Resilience Empowerment Program including 5 sessions with health coaches	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 37 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Personal Resilience Empowerment Program (PREP) in the Perioperative Setting of Surgically Treated Cancer Patients
• Actual Study Start Date: May 30, 2018
• Actual Primary Completion Date: Jun 14, 2021
• Actual Study Completion Date: Jun 14, 2021

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Study arm - PREP Intervention 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.

Outcome Measures

Primary Outcome Measures

1. 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

2. 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

3. 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

4. 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

5. Change in Quality of Life Post Intervention (Coaching Sessions) - Sleep [At 1 month Post intervention (survey was sent at 30 days after the last couching session)]

   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

6. Change in Quality of Life Post Intervention (Coaching Sessions) - Activity [At 1 month Post intervention (survey was sent at 30 days after the last couching session)]

   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

7. Change in Quality of Life Post Intervention (Coaching Sessions) - Purpose [At 1 month Post intervention (survey was sent at 30 days after the last couching session)]

   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

8. Change in Quality of Life Post Intervention (Coaching Sessions) - Nutrition [At 1 month Post intervention (survey was sent at 30 days after the last couching session)]

   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

9. Change in Quality of Life Post Intervention (Coaching Sessions) - Sleep [At 3 month Post intervention (survey was sent at 90 days after the last couching session)]

   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

10. Change in Quality of Life Post Intervention (Coaching Sessions) - Activity [At 3 month Post intervention (survey was sent at 90 days after the last couching session)]

    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

11. Change in Quality of Life Post Intervention (Coaching Sessions) - Purpose [At 3 month Post intervention (survey was sent at 90 days after the last couching session)]

    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

12. Change in Quality of Life Post Intervention (Coaching Sessions) - Nutrition [At 3 month Post intervention (survey was sent at 90 days after the last couching session)]

    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

13. 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

14. Change in Quality of Life Post Intervention (Coaching Sessions) - Resilience [At 1 month Post intervention (survey was sent at 30 days after the last couching 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 1-month post intervention survey

15. Change in Quality of Life Post Intervention (Coaching Sessions) - Resilience [At 3 month Post intervention (survey was sent at 90 days after the last couching 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 3-month post intervention survey

16. 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

17. Change in Quality of Life Post Intervention (Coaching Sessions) - Empowerment [At 1 month Post intervention (survey was sent at 30 days after the last couching 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 1-month post intervention survey

18. Change in Quality of Life Post Intervention (Coaching Sessions) - Empowerment [At 3 month Post intervention (survey was sent at 90 days after the last couching 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 3-month post intervention survey

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hackensack Meridian Health - Jersey Shore University Medical Center	Neptune	New Jersey	United States	07753
2	Hackensack Meridian Health - Riverview Medical Center	Red Bank	New Jersey	United States	07701

Sponsors and Collaborators

• Hackensack Meridian Health

Investigators

• Principal Investigator: Ronald Matteotti, MD, Hackensack Meridian Health

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jun 19, 2018

More Information

Publications

None provided.

• Responsible Party: Hackensack Meridian Health
• ClinicalTrials.gov Identifier: NCT03644173
• Other Study ID Numbers: IRB#201801121J
• First Posted: Aug 23, 2018
• Last Update Posted: Oct 15, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Hackensack Meridian Health: integrative medicine; cancer patients
• Additional relevant MeSH terms: Cholangiocarcinoma

Study Results

Participant Flow

Arm/Group Title	Personal Resilience Empowerment Program
Arm/Group Description	Participants who were enrolled and completed all visits
Period Title: Participants at Last Visit (Pre-surveys)
STARTED	37
COMPLETED	16
NOT COMPLETED	21
Period Title: Participants at Last Visit (Pre-surveys)
STARTED	16
COMPLETED	12
NOT COMPLETED	4
Period Title: Participants at Last Visit (Pre-surveys)
STARTED	12
COMPLETED	10
NOT COMPLETED	2

Baseline Characteristics

Arm/Group Title	Personal Resilience Empowerment Program
Arm/Group Description	Participants who were enrolled and attended at least one visit
Overall Participants	16
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	6 37.5%
>=65 years	10 62.5%
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	67.68
Sex: Female, Male (Count of Participants)
Female	5 31.3%
Male	11 68.8%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	1 6.3%
White	15 93.8%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
United States	16 100%

Outcome Measures

1. Primary Outcome

Title	Change in Quality of Life Post Intervention (Coaching Sessions) - Sleep
Description	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)

Outcome Measure Data

Analysis Population Description

Change in the question regarding sleep (t-test) between the pre and the post intervention survey

Arm/Group Title	Personal Resilience Empowerment Program
Arm/Group Description	Participants who were enrolled and attended at least one visit
Measure Participants	16
7-8 hours of sleep/day	-1.06 (1.95)
Waking up rested	-0.80 (1.97)

2. Primary Outcome

Title	Change in Quality of Life Post Intervention (Coaching Sessions) - Activity
Description	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)

Outcome Measure Data

Analysis Population Description

Change in the question regarding activity (t-test) between the pre and the post intervention survey

Arm/Group Title	Personal Resilience Empowerment Program
Arm/Group Description	Participants who were enrolled and attended at least one visit
Measure Participants	16
Remaining physically active	-0.13 (1.78)
Needing help with everyday activities	0.56 (1.90)

3. Primary Outcome

Title	Change in Quality of Life Post Intervention (Coaching Sessions) - Purpose
Description	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)

Outcome Measure Data

Analysis Population Description

Change in the question regarding activity (t-test) between the pre and the post intervention survey

Arm/Group Title	Personal Resilience Empowerment Program
Arm/Group Description	Participants who were enrolled and attended at least one visit
Measure Participants	16
Mean (Standard Deviation) [scores on a scale]	-0.19 (0.66)

4. Primary Outcome

Title	Change in Quality of Life Post Intervention (Coaching Sessions) - Nutrition
Description	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)

Outcome Measure Data

Analysis Population Description

Change in the question regarding activity (t-test) between the pre and the post intervention survey

Arm/Group Title	Personal Resilience Empowerment Program
Arm/Group Description	Participants who were enrolled and attended at least one visit
Measure Participants	15
5-10 servings of fruits/day	0.60 (1.40)
Avoiding fast food	1.00 (1.56)

5. Primary Outcome

Title	Change in Quality of Life Post Intervention (Coaching Sessions) - Sleep
Description	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)

Outcome Measure Data

Analysis Population Description

Change in the question regarding sleep (t-test) between the pre and the 1-month post intervention survey

Arm/Group Title	Personal Resilience Empowerment Program
Arm/Group Description	Participants who were enrolled and attended at least one visit
Measure Participants	12
7-8 hours of sleep/day	-0.33 (1.23)
Waking up rested	0.08 (1.16)

6. Primary Outcome

Title	Change in Quality of Life Post Intervention (Coaching Sessions) - Activity
Description	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)

Outcome Measure Data

Analysis Population Description

Change in the question regarding activity (t-test) between the pre and the post intervention survey

Arm/Group Title	Personal Resilience Empowerment Program
Arm/Group Description	Participants who were enrolled and attended at least one visit
Measure Participants	12
Remaining physically active	0.67 (1.23)
Needing help with everyday activities	-0.08 (1.73)

7. Primary Outcome

Title	Change in Quality of Life Post Intervention (Coaching Sessions) - Purpose
Description	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)

Outcome Measure Data

Analysis Population Description

Change in the question regarding activity (t-test) between the pre and the post intervention survey

Arm/Group Title	Personal Resilience Empowerment Program
Arm/Group Description	Participants who were enrolled and attended at least one visit
Measure Participants	12
Mean (Standard Deviation) [scores on a scale]	-0.33 (0.89)

8. Primary Outcome

Title	Change in Quality of Life Post Intervention (Coaching Sessions) - Nutrition
Description	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)

Outcome Measure Data

Analysis Population Description

Change in the question regarding activity (t-test) between the pre and the post intervention survey

Arm/Group Title	Personal Resilience Empowerment Program
Arm/Group Description	Participants who were enrolled and attended at least one visit
Measure Participants	12
5-10 servings of fruits/day	0.45 (1.51)
Avoiding fast food	0.36 (1.96)

9. Primary Outcome

Title	Change in Quality of Life Post Intervention (Coaching Sessions) - Sleep
Description	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)

Outcome Measure Data

Analysis Population Description

Change in the question regarding sleep (t-test) between the pre and the 3-month post intervention survey

Arm/Group Title	Personal Resilience Empowerment Program
Arm/Group Description	Participants who were enrolled and attended at least one visit
Measure Participants	10
7-8 hours of sleep/day	-0.63 (1.51)
Waking up rested	-0.80 (1.55)

10. Primary Outcome

Title	Change in Quality of Life Post Intervention (Coaching Sessions) - Activity
Description	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)

Outcome Measure Data

Analysis Population Description

Change in the question regarding activity (t-test) between the pre and the 3-month post intervention survey

Arm/Group Title	Personal Resilience Empowerment Program
Arm/Group Description	Participants who were enrolled and attended at least one visit
Measure Participants	10
Remaining physically active	0.70 (0.95)
Needing help with everyday activities	-0.80 (1.48)

11. Primary Outcome

Title	Change in Quality of Life Post Intervention (Coaching Sessions) - Purpose
Description	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)

Outcome Measure Data

Analysis Population Description

Change in the question regarding activity (t-test) between the pre and the 3- month post intervention survey

Arm/Group Title	Personal Resilience Empowerment Program
Arm/Group Description	Participants who were enrolled and attended at least one visit
Measure Participants	9
Mean (Standard Deviation) [scores on a scale]	-0.22 (0.44)

12. Primary Outcome

Title	Change in Quality of Life Post Intervention (Coaching Sessions) - Nutrition
Description	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)

Outcome Measure Data

Analysis Population Description

Change in the question regarding activity (t-test) between the pre and the 3- month post intervention survey

Arm/Group Title	Personal Resilience Empowerment Program
Arm/Group Description	Participants who were enrolled and attended at least one visit
Measure Participants	9
5-10 servings of fruits/day	0.44 (1.81)
Avoiding fast food	0.89 (2.42)

13. Primary Outcome

Title	Change in Quality of Life Post Intervention (Coaching Sessions) - Resilience
Description	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)

Outcome Measure Data

Analysis Population Description

Change in the question regarding sleep (t-test) between the pre and the post intervention survey

Arm/Group Title	Personal Resilience Empowerment Program
Arm/Group Description	Participants who were enrolled and attended at least one visit
Measure Participants	16
Adapting to changes	0.00 (0.63)
Bouncing back from illness/injury and hardship	-0.13 (0.64)

14. Primary Outcome

Title	Change in Quality of Life Post Intervention (Coaching Sessions) - Resilience
Description	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)

Outcome Measure Data

Analysis Population Description

Change in the question regarding sleep (t-test) between the pre and the post intervention survey

Arm/Group Title	Personal Resilience Empowerment Program
Arm/Group Description	Participants who were enrolled and attended at least one visit
Measure Participants	12
Adapting to changes	0.00 (0.95)
Bouncing back from illness/injury and hardship	-0.36 (0.50)

15. Primary Outcome

Title	Change in Quality of Life Post Intervention (Coaching Sessions) - Resilience
Description	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)

Outcome Measure Data

Analysis Population Description

Change in the question regarding sleep (t-test) between the pre and the 3-month post intervention survey

Arm/Group Title	Personal Resilience Empowerment Program
Arm/Group Description	Participants who were enrolled and attended at least one visit
Measure Participants	9
Adapting to changes	0.00 (0.87)
Bouncing back from illness/injury and hardship	-0.11 (0.33)

16. Primary Outcome

Title	Change in Quality of Life Post Intervention (Coaching Sessions) - Empowerment
Description	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)

Outcome Measure Data

Analysis Population Description

Change in the question regarding sleep (t-test) between the pre and the post intervention survey

Arm/Group Title	Personal Resilience Empowerment Program
Arm/Group Description	Participants who were enrolled and attended at least one visit
Measure Participants	16
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)

17. Primary Outcome

Title	Change in Quality of Life Post Intervention (Coaching Sessions) - Empowerment
Description	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)

Outcome Measure Data

Analysis Population Description

Change in the question regarding sleep (t-test) between the pre and the 1-month post intervention survey

Arm/Group Title	Personal Resilience Empowerment Program
Arm/Group Description	Participants who were enrolled and attended at least one visit
Measure Participants	12
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)

18. Primary Outcome

Title	Change in Quality of Life Post Intervention (Coaching Sessions) - Empowerment
Description	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)

Outcome Measure Data

Analysis Population Description

Change in the question regarding sleep (t-test) between the pre and the 1-month post intervention survey

Arm/Group Title	Personal Resilience Empowerment Program
Arm/Group Description	Participants who were enrolled and attended at least one visit
Measure Participants	10
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)

Adverse Events

Time Frame	3 months post-op
Adverse Event Reporting Description	Any adverse events related to the Personal Resilience Empowerment Program Study
Arm/Group Title	Personal Resilience Empowerment Program (All Visits and Follow up)		Personal Resilience Empowerment Program (Visits Only)
Arm/Group Description	Participants who were enrolled, completed all visits and completed the two follow-up visits (1 month and 3 months post-op)		Participants who were enrolled and completed the first three visits (but not follow-up)
All Cause Mortality
	Personal Resilience Empowerment Program (All Visits and Follow up)		Personal Resilience Empowerment Program (Visits Only)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		2/16 (12.5%)
Serious Adverse Events
	Personal Resilience Empowerment Program (All Visits and Follow up)		Personal Resilience Empowerment Program (Visits Only)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		2/16 (12.5%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Death due to underlining cancer	0/10 (0%)	0	2/16 (12.5%)	2
Other (Not Including Serious) Adverse Events
	Personal Resilience Empowerment Program (All Visits and Follow up)		Personal Resilience Empowerment Program (Visits Only)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/16 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.