Esophageal CancerNCT04520867
STRENGTH Expansion
An observational study of Esophageal Cancer and Gastroesophageal Junction Cancer, run by University of Colorado, Denver at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Cancer, Gastroesophageal Junction Cancer
- What is being tested?
- STRENGTH
- Type of treatment
- Pill or oral medicine
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Aug 2020to 16 Nov 2021
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Hospital
Aurora, Colorado, 80045
About this study
Official title: 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.
Read the 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.
- Being tested
- STRENGTH
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STRENGTHOther
Also called STRIVING TO REACTIVATE ESOPHAGEAL AND GASTRIC HEALTH
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 group | Role | What they receive |
|---|---|---|
| Qualifying Subjects | Patients seen in the EGMDC for treatment planning who are recommended to receive neoadjuvant treatment followed by surgery at UCCC Metro Receives: Other: STRENGTH |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: pre-treatment baseline and 6 months post-surgery
Secondary outcomes (4)
Changes in Weight
Documented by dietitian
Measured: 9 months
Malnutrition Scores
This will be assessed by the dietitian on a scale of Mild, Moderate or Severe.
Measured: 9 months
Dysphagia Score
This will be assessed by the dietitian on a scale of Mild, Moderate or Severe.
Measured: 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.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2020
- Study start6 Aug 2020
- Primary completion16 Nov 2021
- Study completion16 Nov 2021
Why it stopped: PI is leaving the institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04520867
- Sponsor's protocol ID
- 20-0246.cc
- Other IDs
- P30CA046934
- Status last verified
- Nov 2021
- First submitted
- 13 Aug 2020
- Last updated
- 24 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expansion And Evaluation Of The University Of Colorado Strength (Striving To Reactivate Esophageal And Gastric Health) Prehabilitation Program
- ClinicalTrials.gov ID
- NCT04520867
- Acronym / sponsor ID
- 20-0246.cc
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: PI is leaving the institution
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 6 Aug 2020 (actual)
- Primary completion
- 16 Nov 2021 (actual)
- Study completion
- 16 Nov 2021 (actual)
- First posted
- 20 Aug 2020 (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.
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.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Qualifying Subjects | – | Other: STRENGTHPatients seen in the EGMDC for treatment planning who are recommended to receive neoadjuvant treatment followed by surgery at UCCC Metro |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| STRENGTHAlso: STRIVING TO REACTIVATE ESOPHAGEAL AND GASTRIC HEALTHPatients 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 | Qualifying Subjects |
Primary outcome
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.
4 secondary outcomes
Changes in Weight
Time frame: 9 months
Malnutrition Scores
Time frame: 9 months
Dysphagia Score
Time frame: 9 months
PRO CTCAE Scores
Time frame: 9 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophageal Cancer and Gastroesophageal Junction Cancer, run by University of Colorado, Denver 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 6 inclusion and 3 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: withdrawn, as of the sponsor's last update on 24 Nov 2021. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
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). 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 24 Nov 2021; AzTrials last refreshed its copy on 26 Oct 2026.