STRENGTH Expansion

NCT ID: NCT04520867

Last Updated: 2021-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2020-08-06

Study Completion Date

2021-11-16

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Esophageal Cancer Gastroesophageal Junction Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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Qualifying Subjects

Patients seen in the EGMDC for treatment planning who are recommended to receive neoadjuvant treatment followed by surgery at UCCC Metro

STRENGTH

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Other Intervention Names

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STRIVING TO REACTIVATE ESOPHAGEAL AND GASTRIC HEALTH

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Colorado Hospital

Aurora, Colorado, United States

Site Status

Countries

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United States

Other Identifiers

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P30CA046934

Identifier Type: NIH

Identifier Source: secondary_id

View Link

20-0246.cc

Identifier Type: -

Identifier Source: org_study_id