STRENGTH Expansion

November 16, 2021 updated by: University of Colorado, Denver

Expansion And Evaluation Of The University Of Colorado Strength (Striving To Reactivate Esophageal And Gastric Health) Prehabilitation Program

Patients seen in the EGMDC (Esophageal and Gastric Multidisciplinary Clinic) for treatment planning who are recommended to receive neoadjuvant treatment followed by surgery at UCCC Metro will be offered enrollment into the study. Patients will complete the self-assessments outlined below on provided tablet computers during UCCC visits. If unable to complete assessments in person they will be e-mailed via REDCap Survey to the patient to complete individually.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Patients with esophageal (EC) and gastroesophageal junction (GEJC) cancers who are seen in the Esophageal and Gastric Multidisciplinary Clinic (EGMDC) for treatment planning and are recommended to receive neoadjuvant therapy and plan to receive treatment at UCCC Metro will be offered enrollment into the study. Patients will complete the patient reported assessments focused on QOL and physical activity on provided tablet computers during UCCC visits at specified time points. If unable to complete assessments in person they will be e-mailed to the patient via REDCap to complete. Additional data regarding dosing of chemotherapy, radiation, nutrition and surgical outcomes will be collected.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Each year the Esophageal and Gastric Multidisciplinary Clinic (EGMDC) sees nearly 75 patients with stage IB-IIIB EC/GEJC, and about 30 of those patients are treated locally at UCCC Metro. These patients are treated according to the STEGNTH pathway, which is standard of care. Patients will be approached at their EGMDC visit to discuss inclusion in the study

Description

Inclusion Criteria:

  1. Provision to sign and date the consent form
  2. Age ≥ 18 years
  3. Receiving treatment according to the STRENGTH pathway
  4. Diagnosed with esophageal(EC)/gastroesophageal junction cancer(GEJC) stage IB-IIIB
  5. Planning to receive neoadjuvant treatment followed by surgery at University of Colorado Cancer Center (UCCC) Metro
  6. Ability to complete surveys online via an emailed REDCap survey link if unable to complete in person

Exclusion Criteria:

  1. Inability to read English and complete questionnaires independently
  2. Per the investigator, unable to comply with study criteria or assessments
  3. Inability to receive and complete REDCap survey online

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Qualifying Subjects
Patients seen in the EGMDC for treatment planning who are recommended to receive neoadjuvant treatment followed by surgery at UCCC Metro
Other: STRENGTH
Patients with esophageal (EC) and gastroesophageal junction (GEJC) cancers who are seen in the Esophageal and Gastric Multidisciplinary Clinic (EGMDC) for treatment planning and are recommended to receive neoadjuvant therapy and plan to receive treatment at UCCC Metro will be offered enrollment into the study. Patients will complete the patient reported assessments focused on QOL and physical activity on provided tablet computers during UCCC visits at specified time points. If unable to complete assessments in person they will be e-mailed to the patient via REDCap to complete. Additional data regarding dosing of chemotherapy, radiation, nutrition and surgical outcomes will be collected.
Other Names:
  • STRIVING TO REACTIVATE ESOPHAGEAL AND GASTRIC HEALTH

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 Score
Time Frame: pre-treatment baseline and 6 months post-surgery
The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire is a validated patient self-reported tool. It assesses nine multi-item scales: five functional scales (physical, role, cognitive, emotional and social); three symptom scales (fatigue, pain, and nausea and vomiting); and a global health and quality-of-life scale. There are also several single-item symptom measures. Patients self-report using a 4-point Likert scale. Raw scores are transformed to a 0-100 scale, with higher scores representing better functioning/QOL and greater symptom burden.
pre-treatment baseline and 6 months post-surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in Weight
Time Frame: 9 months
Documented by dietitian
9 months
Malnutrition Scores
Time Frame: 9 months
This will be assessed by the dietitian on a scale of Mild, Moderate or Severe.
9 months
Dysphagia Score
Time Frame: 9 months
This will be assessed by the dietitian on a scale of Mild, Moderate or Severe.
9 months
PRO CTCAE Scores
Time Frame: 9 months

The Patient Reported Outcome Common Terminology Criteria for Adverse Events will measure the significance of adverse events, by the patient's determination. A library of 78 symptomatic AEs was developed for patient self-reporting. The toxicities chosen for self-reporting include symptomatic toxicities that can be reasonably reported from the patient perspective such as pain, fatigue, nausea, and cutaneous side effects. Most symptoms are characterized based upon key attributes:

presence/absence, frequency, severity, and/or interference with usual or daily activities. Patients assess toxicities on a 5-point Likert scale with a recall period of the past 7 days.
9 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Godin Exercise Leisure-time Questionnaire
Time Frame: From baseline thru 3 and 6 months post surgery
The Godin-Exercise Leisure-time Questionnaire has been utilized to assess self-reported leisure time, physical activity. This short form focuses on weekly frequencies of strenuous moderate, and light activity as well as engagement in regular leisure activity long enough to work up a sweat. A total weekly leisure activity score can be calculated and categorized into one of three groups: active, moderately active, or insufficiently active. This questionnaire will be modified to assess use of group versus individualized exercise as well.In this scale, a higher scale reflects more exercise.
From baseline thru 3 and 6 months post surgery
QLQ-OES18
Time Frame: From baseline thru 3 and 6 months post surgery
The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Oesophageal module is a validated assessment tool to be used for patients with esophageal cancer undergoing any single or combination of treatments including esophagectomy, chemoradiation, endoscopic palliation or palliative chemotherapy and/or radiotherapy and should be used with the QLQ-C30. The QLQ-OES18 focuses on the extent to which patient have symptoms of problems during the last week in the following areas: eating, reflux, pain, trouble swallowing saliva, choking while swallowing, dry mouth, trouble with taste, trouble with coughing, trouble talking, and dysphagia. The response format is a four-point Likert scale. Responses to the questionnaires are transformed into a 0-100 scale using EORTC guidelines.
From baseline thru 3 and 6 months post surgery
Eastern Cooperative OnCology Group Performance Status
Time Frame: From baseline thru 3 and 6 months post surgery
It describes a patient's level of functioning in terms of their ability to care for themselves, daily activity, and physical ability (walking, working, etc.).
From baseline thru 3 and 6 months post surgery
Surgical Pathologic response in relation to EORTC QLQ-C30
Time Frame: 6 months post surgery
How the patient's actual disease response, on a scale of Complete, Partial, Stable disease, or No Response to treatment, relates to their EORTC QLQ-C30 Score
6 months post surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Colorado, Denver

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Cancer Institute (NCI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 6, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 16, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 16, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 13, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 18, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 20, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 24, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 16, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20-0246.cc
  • P30CA046934 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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