Lung CancerNCT03644173
Personal Resilience Empowerment Program Study
A study testing Personal Resilience Empowerment Program including 5 sessions with health coaches in people with Lung Cancer and Cholangiocarcinoma, run by Hackensack Meridian Health at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Cholangiocarcinoma, Pancreatic Cancer
- What is being tested?
- Personal Resilience Empowerment Program including 5 sessions with health coaches
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 May 2018to 14 Jun 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Hackensack Meridian Health - Jersey Shore University Medical Center
Neptune City, New Jersey, 07753
Hackensack Meridian Health - Riverview Medical Center
Red Bank, New Jersey, 07701
About this study
Official title: Personal Resilience Empowerment Program (PREP) in the Perioperative Setting of Surgically Treated Cancer Patients
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).
Read more
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).
- Conditions
- Lung Cancer, Cholangiocarcinoma, Pancreatic Cancer, Liver Cancer
- Being tested
- Personal Resilience Empowerment Program including 5 sessions with health coaches
- Keywords
- integrative medicine, cancer patients
- Medical subject headings
- Lung Neoplasms, Cholangiocarcinoma, Pancreatic Neoplasms, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personal Resilience Empowerment Program including 5 sessions with health coachesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Study arm - PREP Intervention | Experimental | Participants receiving the coaching intervention Receives: Behavioral: Personal Resilience Empowerment Program including 5 sessions with health coaches |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: At 3 month Post intervention (survey was sent at 90 days after the last couching session)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2018
- Study start30 May 2018
- Primary completion14 Jun 2021
- Study completion14 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hackensack Meridian Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ronald Matteotti, MD, Principal investigator, Hackensack Meridian Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03644173
- Sponsor's protocol ID
- IRB#201801121J
- Status last verified
- Sep 2021
- First submitted
- 20 Aug 2018
- Last updated
- 15 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personal Resilience Empowerment Program (PREP) in the Perioperative Setting of Surgically Treated Cancer Patients
- ClinicalTrials.gov ID
- NCT03644173
- Acronym / sponsor ID
- IRB#201801121J
- Conditions
- Lung Cancer, Cholangiocarcinoma, Pancreatic Cancer, Liver Cancer
- Keywords
- integrative medicine, cancer patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Hackensack Meridian HealthUniversity, hospital or other
- Study start
- 30 May 2018 (actual)
- Primary completion
- 14 Jun 2021 (actual)
- Study completion
- 14 Jun 2021 (actual)
- First posted
- 23 Aug 2018 (actual)
- Results
- Posted 15 Oct 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study arm - PREP Intervention | Experimental | Behavioral: Personal Resilience Empowerment Program including 5 sessions with health coachesParticipants receiving the coaching intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personal Resilience Empowerment Program including 5 sessions with health coaches5 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. | Behavioural | Study arm - PREP Intervention |
Primary outcome
Change in Quality of Life Post Intervention (Coaching Sessions) - Sleep
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)
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
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)
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
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)
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
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)
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) - Sleep
Time frame: 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
Change in Quality of Life Post Intervention (Coaching Sessions) - Activity
Time frame: 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
Change in Quality of Life Post Intervention (Coaching Sessions) - Purpose
Time frame: 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
Change in Quality of Life Post Intervention (Coaching Sessions) - Nutrition
Time frame: 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
Change in Quality of Life Post Intervention (Coaching Sessions) - Sleep
Time frame: 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
Change in Quality of Life Post Intervention (Coaching Sessions) - Activity
Time frame: 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
Change in Quality of Life Post Intervention (Coaching Sessions) - Purpose
Time frame: 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
Change in Quality of Life Post Intervention (Coaching Sessions) - Nutrition
Time frame: 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
Change in Quality of Life Post Intervention (Coaching Sessions) - Resilience
Time frame: 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) - Resilience
Time frame: 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
Change in Quality of Life Post Intervention (Coaching Sessions) - Resilience
Time frame: 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
Change in Quality of Life Post Intervention (Coaching Sessions) - Empowerment
Time frame: 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
Change in Quality of Life Post Intervention (Coaching Sessions) - Empowerment
Time frame: 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
Change in Quality of Life Post Intervention (Coaching Sessions) - Empowerment
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ronald Matteotti, MD principal investigator
Hackensack Meridian Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personal Resilience Empowerment Program including 5 sessions with health coaches in people with Lung Cancer and Cholangiocarcinoma, run by Hackensack Meridian Health at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Quality of Life Post Intervention (Coaching Sessions) - Sleep (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)). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2021; AzTrials last refreshed its copy on 27 Oct 2026.