Pancreatic CancerPhase 4HOPENCT03642093
HOPE - A Study to Evaluate the Effect of a Prehabilitation Program on GI Cancer Patients Planning to Undergo Surgery
A Phase 4 study testing Nutritional Intervention and Physical Activity Intervention in people with Pancreatic Cancer and Esophageal Cancer, run by Siobhan Trotter at 1 site in United States.
Trial summary
A one-group prospective cohort study design with measures collected pre- and post-intervention. The primary goal of this study is to evaluate the effect of a multimodal prehabilitation preoperative program on changes in frailty in upper gastrointestinal surgical oncology patients. Read more about this study
- Who is it for?
- Ages 25 to 80 years
- Conditions the study is for
- Pancreatic Cancer, Esophageal Cancer, Gastric Cancer
- What is being tested?
- Nutritional Intervention and Physical Activity Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2018to May 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 25 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients must be patients of Ochsner being seen at the Ochsner Medical Center (OMC).
- All patients must be 25 to 80 years of age.
- All patients must have a diagnosis of cancer.
- > 10 pound unintentional weight loss within 1 year
- Ability to perform grip strength test and Timed Up and Go (TUG) test
- Willingness to participate in the study, document compliance, and attend clinical appointments
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- All patients must be undergoing one of the following major elective surgical oncologic resections with curative intent:
- Pancreaticoduodenectomy for pancreatic cancer
- Distal pancreatectomy / splenectomy for pancreatic cancer
- Esophageal robotic assisted laparoscopic thoracoscopic esophagectomy for esophageal cancer
- Laparoscopic or open, partial or total gastrectomy for gastric cancer
Who cannot join
- All patients not undergoing oncologic or major resections.
- All patients unwilling or unable to answer questionnaires or accept help to answer electronic or paper questionnaires.
- All patients that are unable to participate in an activity program.
- All patients unable to wear an electronic activity monitoring device.
- All patients not wanting to follow a specific nutritional and breathing intervention.
- All patients that are not able or wishing to consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
Ochsner Medical Center
New Orleans, Louisiana, 70471
About this study
Official title: H.O.P.E. Healing Optimization Through Preoperative Engagement: A Prospective Single Cohort Study to Evaluate the Effect of a Prehabilitation Program on Preoperative Outcomes in Upper GI Surgical Oncology Patients
A one-group prospective cohort study design with measures collected pre- and post-intervention. The primary goal of this study is to evaluate the effect of a multimodal prehabilitation preoperative program on changes in frailty in upper gastrointestinal surgical oncology patients.
Read the detailed description
Cancer patients often develop protein calorie malnutrition, inflammatory states, and loss of lean muscle mass, which can be best categorized as frailty. Frailty affects global health, the ability to carry out normal functions, and even the ability to tolerate targeted curative treatments such as surgery, chemotherapy, and radiation. The Investigators evaluate frailty, and design a study to evaluate the outcomes of the administration of multimodal preoperative prehabilitation programs on those frailty markers. Previous data provides support for interventions that include:
- Improved protein rich nutrition with specific immunonutrition recommendations,
- Treatment of maldigestion or pancreatic insufficiency in pancreatic, gastric, or esophageal cancer patients,
- Brief, evidence-based activity interventions such as walking and inspiratory muscle training (IMT), and
- Disease specific education
These interventions should improve frailty by maintaining or regaining weight, improved grip strength, and improved prealbumin. These markers indicate improvements in nutritional status, increased strength and ability to ambulate, and improved functional status in the preoperative period. Other outcomes that will be reported include fat-soluble vitamin levels, global health, and inflammation.
The preoperative period is the best time to facilitate patient engagement through self-care and proactive activity. Interventions must be easy to accomplish and structured so patients have accountability and both patients and clinicians have methods and tools for measuring progress. Most patients and family members are motivated at this time and understand the need to improve frailty and potentially improve global health.
- Conditions
- Pancreatic Cancer, Esophageal Cancer, Gastric Cancer
- Being tested
- Nutritional Intervention, Physical Activity Intervention
- Keywords
- Frailty, Prehabilitation
- Medical subject headings
- Pancreatic Neoplasms, Esophageal Neoplasms, Stomach Neoplasms, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional InterventionCombination product
Also called Immunonutrition
Nutritional Supplementation for all subjects and Pancreatic Enzyme Replacement Therapy only for subjects with Exocrine Pancreatic Insufficiency
Physical Activity InterventionBehavioural
Walking and Inspiratory Muscle Training
| Study group | Role | What they receive |
|---|---|---|
| Frail | Experimental | Subjects assessed and determined to be Frail and meet trial eligibility criteria will be enrolled on Frail Arm and begin a 4 Week program consisting of Nutritional Interventions and Physical Activity Interventions Receives: Combination Product: Nutritional Intervention; Behavioral: Physical Activity Intervention |
| Not Frail | Active comparator | Subjects assessed and determined to be Not Frail and meet trial eligibility criteria will be enrolled on Not Frail Arm and begin a 4 Week program consisting of Nutritional Interventions and Physical Activity Interventions Receives: Combination Product: Nutritional Intervention; Behavioral: Physical Activity Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frailty Measurement
Frailty will be measured using 3 criteria: weight loss, grip strength, and prealbumin serum level
Measured: 4 Weeks
Secondary outcomes (2)
Vitamin levels
Measured: 4 Weeks
Quality of Life (QoL) Assessment
QoL will be assessed using Patient-Reported Outcome Measurement Information System (PROMIS) Global Health Questionnaire - PROMIS Scale v1.2 - Global Health
Measured: 4 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2018
- Study start1 Aug 2018
- Primary completionDec 2018 (estimated)
- Study completionMay 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Siobhan Trotter
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Siobhan Trotter, Ochsner Health System
- Investigators
- Siobhan M Trotter, DNP, Principal investigator, Ochsner Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03642093
- Sponsor's protocol ID
- HOPE Study 2018.045
- Acronym
- HOPE
- Status last verified
- Sep 2018
- First submitted
- 20 Jun 2018
- Last updated
- 11 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- H.O.P.E. Healing Optimization Through Preoperative Engagement: A Prospective Single Cohort Study to Evaluate the Effect of a Prehabilitation Program on Preoperative Outcomes in Upper GI Surgical Oncology Patients
- ClinicalTrials.gov ID
- NCT03642093
- Acronym / sponsor ID
- HOPE / HOPE Study 2018.045
- Conditions
- Pancreatic Cancer, Esophageal Cancer, Gastric Cancer
- Keywords
- Frailty, Prehabilitation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Siobhan TrotterUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- May 2019 (estimated)
- First posted
- 22 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A one-group prospective cohort study design with measures collected pre- and post-intervention. The primary goal of this study is to evaluate the effect of a multimodal prehabilitation preoperative program on changes in frailty in upper gastrointestinal surgical oncology patients.
Detailed description
Cancer patients often develop protein calorie malnutrition, inflammatory states, and loss of lean muscle mass, which can be best categorized as frailty. Frailty affects global health, the ability to carry out normal functions, and even the ability to tolerate targeted curative treatments such as surgery, chemotherapy, and radiation. The Investigators evaluate frailty, and design a study to evaluate the outcomes of the administration of multimodal preoperative prehabilitation programs on those frailty markers. Previous data provides support for interventions that include:
- Improved protein rich nutrition with specific immunonutrition recommendations,
- Treatment of maldigestion or pancreatic insufficiency in pancreatic, gastric, or esophageal cancer patients,
- Brief, evidence-based activity interventions such as walking and inspiratory muscle training (IMT), and
- Disease specific education
These interventions should improve frailty by maintaining or regaining weight, improved grip strength, and improved prealbumin. These markers indicate improvements in nutritional status, increased strength and ability to ambulate, and improved functional status in the preoperative period. Other outcomes that will be reported include fat-soluble vitamin levels, global health, and inflammation.
The preoperative period is the best time to facilitate patient engagement through self-care and proactive activity. Interventions must be easy to accomplish and structured so patients have accountability and both patients and clinicians have methods and tools for measuring progress. Most patients and family members are motivated at this time and understand the need to improve frailty and potentially improve global health.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Frail | Experimental | Combination Product: Nutritional Intervention, Behavioral: Physical Activity InterventionSubjects assessed and determined to be Frail and meet trial eligibility criteria will be enrolled on Frail Arm and begin a 4 Week program consisting of Nutritional Interventions and Physical Activity Interventions |
| Not Frail | Active comparator | Combination Product: Nutritional Intervention, Behavioral: Physical Activity InterventionSubjects assessed and determined to be Not Frail and meet trial eligibility criteria will be enrolled on Not Frail Arm and begin a 4 Week program consisting of Nutritional Interventions and Physical Activity Interventions |
Who may qualify
- Ages
- 25 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- All patients must be patients of Ochsner being seen at the Ochsner Medical Center (OMC).
- All patients must be 25 to 80 years of age.
- All patients must have a diagnosis of cancer.
- > 10 pound unintentional weight loss within 1 year
- Ability to perform grip strength test and Timed Up and Go (TUG) test
Key exclusion criteria (6 listed)
- All patients not undergoing oncologic or major resections.
- All patients unwilling or unable to answer questionnaires or accept help to answer electronic or paper questionnaires.
- All patients that are unable to participate in an activity program.
- All patients unable to wear an electronic activity monitoring device.
- All patients not wanting to follow a specific nutritional and breathing intervention.
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 |
|---|---|---|
| Nutritional InterventionAlso: ImmunonutritionNutritional Supplementation for all subjects and Pancreatic Enzyme Replacement Therapy only for subjects with Exocrine Pancreatic Insufficiency | Combination product | Frail, Not Frail |
| Physical Activity InterventionWalking and Inspiratory Muscle Training | Behavioural | Frail, Not Frail |
Primary outcome
Frailty Measurement
Time frame: 4 Weeks
Frailty will be measured using 3 criteria: weight loss, grip strength, and prealbumin serum level
2 secondary outcomes
Vitamin levels
Time frame: 4 Weeks
Quality of Life (QoL) Assessment
Time frame: 4 Weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2018.
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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.
Siobhan M Trotter, DNP principal investigator
Ochsner Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nutritional Intervention and Physical Activity Intervention in people with Pancreatic Cancer and Esophageal Cancer, run by Siobhan Trotter at 1 site 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 11 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 11 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Frailty Measurement (time frame: 4 Weeks). 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 11 Sep 2018.