Clinical trial NCT04520867: STRENGTH Expansion
Official title: Expansion And Evaluation Of The University Of Colorado Strength (Striving To Reactivate Esophageal And Gastric Health) Prehabilitation Program
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Esophageal Cancer
Gastroesophageal Junction Cancer
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2020-08-20
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
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

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.

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.

Eligibility 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

Primary outcomes:
measure: Change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 Score
timeFrame: pre-treatment baseline and 6 months post-surgery
Secondary outcomes:
measure: Changes in Weight
timeFrame: 9 months
measure: Malnutrition Scores
timeFrame: 9 months
measure: Dysphagia Score
timeFrame: 9 months
measure: PRO CTCAE Scores
timeFrame: 9 months
Other outcomes:
measure: Godin Exercise Leisure-time Questionnaire
timeFrame: From baseline thru 3 and 6 months post surgery
measure: QLQ-OES18
timeFrame: From baseline thru 3 and 6 months post surgery
measure: Eastern Cooperative OnCology Group Performance Status
timeFrame: From baseline thru 3 and 6 months post surgery
measure: Surgical Pathologic response in relation to EORTC QLQ-C30
timeFrame: 6 months post surgery
Locations:
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
Study officials:
References: