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STRENGTH Expansion

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04520867
Recruitment Status : Not yet recruiting
First Posted : August 20, 2020
Last Update Posted : January 11, 2021
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Colorado, Denver

Brief Summary:
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.

Condition or disease Intervention/treatment
Esophageal Cancer Gastroesophageal Junction Cancer Other: STRENGTH

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.

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Study Type : Observational
Estimated Enrollment : 28 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Expansion And Evaluation Of The University Of Colorado Strength (Striving To Reactivate Esophageal And Gastric Health) Prehabilitation Program
Estimated Study Start Date : March 2021
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : September 2023

Resource links provided by the National Library of Medicine


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
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 Name: STRIVING TO REACTIVATE ESOPHAGEAL AND GASTRIC HEALTH




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Changes in Weight [ Time Frame: 9 months ]
    Documented by dietitian

  2. Malnutrition Scores [ Time Frame: 9 months ]
    This will be assessed by the dietitian on a scale of Mild, Moderate or Severe.

  3. Dysphagia Score [ Time Frame: 9 months ]
    This will be assessed by the dietitian on a scale of Mild, Moderate or Severe.

  4. 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.



Other Outcome Measures:
  1. 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.

  2. 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.

  3. 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.).

  4. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04520867


Contacts
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Contact: Megan Marsh (720)848-0405 megan.marsh@cuanschutz.edu

Sponsors and Collaborators
University of Colorado, Denver
National Cancer Institute (NCI)
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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT04520867    
Other Study ID Numbers: 20-0246.cc
P30CA046934 ( U.S. NIH Grant/Contract )
First Posted: August 20, 2020    Key Record Dates
Last Update Posted: January 11, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No