Spots Global Cancer Trial Database for Anxiety and Fear of Cancer Before and After Banding Without Resection in Small SET Management (QUALI-BANDING-SET)
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Trial Identification
Brief Title: Anxiety and Fear of Cancer Before and After Banding Without Resection in Small SET Management (QUALI-BANDING-SET)
Official Title: Anxiety, Fear of Cancer and Quality of Life Degree Before and After Endoscopic Band Ligation Without Resection in Subepithelial Tumours of the Digestive Tract ≤15-mm Management: a Multicenter Prospective Study
Study ID: NCT04316000
Conditions
Study Description
Brief 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.
Detailed Description: This "Quality of Life" study is directly related to the "BANDING-SET" study (NCT03247231), whose main aim is to analyze the effectiveness and safety of endoscopic band ligation without resection in the small gastrointestinal subepithelial tumours management. Using three validated tests (Hospital Anxiety and Depression Scale \[HADS\], Cancer Worry Scale \[CWS\] and European Five-Dimension Quality of Live test \[EuroQol-5D\]) patients are evaluated before and after the endoscopic procedure. Three main groups of patients are presented: * GROUP A, in which the subephitelial tumour is successfully removed \[hypothesis: anxiety and fear of cancer should decrease\]. * GROUP B, in which the subephitelial tumour is not successfully removed due to various reasons (size \>15-mm, not technical success,...) \[hypothesis: anxiety and fear of cancer shuold be similar before-after\]. * GROUP C, in which the subephitelial tumour is not observed or is a benign entity, which does not require further interventions for these patients \[hypothesis: anxiety and fear of cancer should decrease\].
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Hospital Universitari Germans Trias i Pujol (Can Ruti), Badalona, Barcelona, Catalonia, Spain
Hospital Universitari de Bellvitge, L'Hospitalet de Llobregat, Barcelona, Catalonia, Spain
Hospital Universitari Mútua de Terrassa, Terrassa, Barcelona, Catalonia, Spain
Hospital de Sant Pau i de la Santa Creu, Barcelona, Catalonia, Spain
Hospital Universitari de Girona Doctor Josep Trueta, Girona, Catalonia, Spain
Hospital Universitari Arnau de Vilanova de Lleida, Lleida, Catalonia, Spain
Hospital Universitari Joan XXIII de Tarragona, Tarragona, Catalonia, Spain
Contact Details
Name: Francesc Bas-Cutrina, MD
Affiliation: Endoscopy Unit; Digestive Diseases Department; H. Universitari de Bellvitge.
Role: PRINCIPAL_INVESTIGATOR
Name: Joan B Gornals, MD, PhD
Affiliation: Endoscopy Unit; Digestive Diseases Department; H. Universitari de Bellvitge.
Role: PRINCIPAL_INVESTIGATOR
Name: Sebastià Videla, MD, PhD
Affiliation: Department of Clinical Pharmacology; H. Universitari de Bellvitge.
Role: PRINCIPAL_INVESTIGATOR
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