NCT04520867

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2020

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 6, 2020

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

August 13, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 20, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 16, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 16, 2021

Completed
Last Updated

November 24, 2021

Status Verified

November 1, 2021

Enrollment Period

1.3 years

First QC Date

August 13, 2020

Last Update Submit

November 16, 2021

Conditions

Esophageal CancerGastroesophageal Junction Cancer

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (4)

  • Changes in Weight

    9 months

  • Malnutrition Scores

    9 months

  • Dysphagia Score

    9 months

  • PRO CTCAE Scores

    9 months

Other Outcomes (4)

  • Godin Exercise Leisure-time Questionnaire

    From baseline thru 3 and 6 months post surgery

  • QLQ-OES18

    From baseline thru 3 and 6 months post surgery

  • Eastern Cooperative OnCology Group Performance Status

    From baseline thru 3 and 6 months post surgery

  • +1 more other outcomes

Study Arms (1)

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

Interventions

STRENGTHOTHER

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.

Also known as: STRIVING TO REACTIVATE ESOPHAGEAL AND GASTRIC HEALTH
Qualifying Subjects

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases
0

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 13, 2020

First Posted

August 20, 2020

Study Start

August 6, 2020

Primary Completion

November 16, 2021

Study Completion

November 16, 2021

Last Updated

November 24, 2021

Record last verified: 2021-11

Locations

US(1)