- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04520867
STRENGTH Expansion
Expansion And Evaluation Of The University Of Colorado Strength (Striving To Reactivate Esophageal And Gastric Health) Prehabilitation Program
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Contacts and Locations
Study Locations
-
-
Colorado
-
Aurora, Colorado, United States, 80045
- University of Colorado Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Provision to sign and date the consent form
- Age ≥ 18 years
- Receiving treatment according to the STRENGTH pathway
- Diagnosed with esophageal(EC)/gastroesophageal junction cancer(GEJC) stage IB-IIIB
- Planning to receive neoadjuvant treatment followed by surgery at University of Colorado Cancer Center (UCCC) Metro
- Ability to complete surveys online via an emailed REDCap survey link if unable to complete in person
Exclusion Criteria:
- Inability to read English and complete questionnaires independently
- Per the investigator, unable to comply with study criteria or assessments
- Inability to receive and complete REDCap survey online
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Qualifying Subjects
Patients seen in the EGMDC for treatment planning who are recommended to receive neoadjuvant treatment followed by surgery at UCCC Metro
|
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:
|
What is the study measuring?
Primary Outcome Measures
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
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
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
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 20-0246.cc
- P30CA046934 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Esophageal Cancer
-
OHSU Knight Cancer InstituteOregon Health and Science UniversityWithdrawnStage IIB Esophageal Cancer AJCC v7 | Stage III Esophageal Cancer AJCC v7 | Stage IIIA Esophageal Cancer AJCC v7 | Stage IIIB Esophageal Cancer AJCC v7 | Stage IIIC Esophageal Cancer AJCC v7
-
National Cancer Institute (NCI)NRG OncologyCompletedEsophageal Adenocarcinoma | Gastroesophageal Junction Adenocarcinoma | Stage IIA Esophageal Cancer AJCC v7 | Stage IIB Esophageal Cancer AJCC v7 | Stage IIIA Esophageal Cancer AJCC v7 | Stage IIIB Esophageal Cancer AJCC v7 | Stage IB Esophageal Cancer AJCC v7United States
-
AIO-Studien-gGmbHBristol-Myers SquibbCompletedEsophageal Cancer | Gastrooesophageal Cancer | Oesophageal Cancer | GastroEsophageal Cancer | Esophageal Cancers NOS | Oesophageal Cancer Metastatic | Esophageal Cancer Metastatic | Oesophageal Cancer NosGermany
-
Cancer Institute and Hospital, Chinese Academy...Tianjin Medical University Cancer Institute and Hospital; Sichuan Cancer Hospital...UnknownEsophageal Neoplasm | Esophageal Cancer TNM Staging Primary Tumor (T) T3 | Esophageal Cancer TNM Staging Primary Tumor (T) T2 | Esophageal Cancer TNM Staging Regional Lymph Nodes (N) N0 | Esophageal Cancer TNM Staging Distal Metastasis (M) M0China
-
University of Wisconsin, MadisonActive, not recruitingResectable Esophageal Cancer | GastroEsophageal CancerUnited States
-
Academisch Medisch Centrum - Universiteit van Amsterdam...UMC UtrechtCompletedEsophageal Cancer, Stage II | Esophageal Cancer Stage IIINetherlands
-
Tianjin Medical University Cancer Institute and...The First Affiliated Hospital with Nanjing Medical University; The First Affiliated... and other collaboratorsUnknownEsophageal Cancer Stage III | Esophageal Cancer Stage IIBChina
-
Tianjin Medical University Cancer Institute and...Sun Yat-sen University; Cancer Institute and Hospital, Chinese Academy of Medical... and other collaboratorsNot yet recruitingStage III Esophageal Cancer | Stage II Esophageal Cancer
-
Tianjin Medical University Cancer Institute and...UnknownStage III Esophageal Cancer | Stage II Esophageal CancerChina
-
National Cancer Institute (NCI)RecruitingNeoplasms | Esophageal Neoplasms | Esophagus Cancer | Esophagus Neoplasm | Neoplasms, Esophageal | Esophageal Cancer (EsC)United States
Clinical Trials on STRENGTH
-
University of FloridaCompletedSleep Apnea, Obstructive | SnoringUnited States
-
University of LiegeUnknownQuality of Life | Critical Illness | Muscle Strength | Grip Strength | Quadriceps StrengthBelgium
-
Universidad Autónoma de Manizales, ColombiaCompletedFemale | Volleyball | PlayerColombia
-
Norwegian University of Science and TechnologyCompleted
-
University of FloridaCompleted
-
University of LiegeCompletedCritical Illness | Muscle Weakness | Physical Disability | Physical DependenceBelgium
-
Christian DallCompletedHeart Failure | Ischemic Heart Disease | Heart Transplant RecipientsDenmark
-
Investigación en Hemofilia y FisioterapiaCompleted
-
Isra UniversityCompleted
-
University of British ColumbiaCanadian Institutes of Health Research (CIHR)CompletedDiabetic | CardiovascularCanada