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Anxiety and Fear of Cancer Before and After Banding Without Resection in Small SET Management (QUALI-BANDING-SET)

NCT04316000 · Status: SUSPENDED · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2021-09-08

No results posted yet for this study

Summary

To analyze the hypothetical improvement in anxiety degree, quality of life and fear of cancer in patients diagnosed with a small gastrointestinal subeptithelial tumor when opting for the removal of the lesion.

Conditions

  • Gastrointestinal Subepithelial Tumors

Interventions

OTHER

Initial Anxiety and Fear of Cancer Test

Answer to Hospital Anxiety and Depression Scale (HADS), Cancer Worry Scale (CWS) and European Five-Dimension Quality of Live test (EuroQol-5D) before the initial endoscopic procedure.

PROCEDURE

Endoscopic band ligation without resection of the subpetihelial tumour.

Correct application of the elastic band in the subepithelial tumor, achieving its removal by self-amputation in the 4-6 weeks endoscopic ultrasonography (EUS) control.

OTHER

1-2 Months Anxiety and Fear of Cancer Test

Answer to Hospital Anxiety and Depression Scale (HADS), Cancer Worry Scale (CWS) and European Five-Dimension Quality of Live test (EuroQol-5D) after 1-2 months of the initial endoscopic procedure, knowing whether the tumor has either been removed or not, is a benign entity or has not been observed.

OTHER

1 Year Anxiety and Fear of Cancer Test

Answer to Hospital Anxiety and Depression Scale (HADS), Cancer Worry Scale (CWS) and European Five-Dimension Quality of Live test (EuroQol-5D) after 1 year of the initial endoscopic procedure, knowing whether the tumor has either been removed or not.

Sponsors & Collaborators

  • Francesc Bas-Cutrina

    lead OTHER

Principal Investigators

  • Francesc Bas-Cutrina, MD · Endoscopy Unit; Digestive Diseases Department; H. Universitari de Bellvitge.

  • Joan B Gornals, MD, PhD · Endoscopy Unit; Digestive Diseases Department; H. Universitari de Bellvitge.

  • Sebastià Videla, MD, PhD · Department of Clinical Pharmacology; H. Universitari de Bellvitge.

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-22
Primary Completion
2021-03-30
Completion
2022-03-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04316000 on ClinicalTrials.gov