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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA046934 | U.S. NIH Grant/Contract | View source |
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PI is leaving the institution
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Qualifying Subjects | Patients seen in the EGMDC for treatment planning who are recommended to receive neoadjuvant treatment followed by surgery at UCCC Metro |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| STRENGTH | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 Score | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Weight | Documented by dietitian | 9 months |
| Malnutrition Scores | This will be assessed by the dietitian on a scale of Mild, Moderate or Severe. |
| Measure | Description | Time Frame |
|---|---|---|
| Godin Exercise Leisure-time Questionnaire | 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. |
Inclusion Criteria:
Exclusion Criteria:
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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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Hospital | Aurora | Colorado | 80045 | United States |
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| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| 9 months |
| Dysphagia Score | This will be assessed by the dietitian on a scale of Mild, Moderate or Severe. | 9 months |
| PRO CTCAE Scores | 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 |
| From baseline thru 3 and 6 months post surgery |
| QLQ-OES18 | 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 | 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 | 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 |
| D006258 |
| Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |