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

Francesc Bas-Cutrina150 enrolled

Overview

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.

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 \[hypothesis: anxiety and fear of cancer should decrease\].

Study Type

OBSERVATIONAL

Enrollment

150

Conditions

Gastrointestinal Subepithelial Tumors

Interventions

Initial Anxiety and Fear of Cancer TestOTHER

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.

Endoscopic band ligation without resection of the subpetihelial tumour.PROCEDURE

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.

1-2 Months Anxiety and Fear of Cancer TestOTHER

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

INCLUSION CRITERIA: * Age between 18 and 80 years. * Patient able to sign and understand the Informed Consent. * Patient with a previously corroborated diagnosis of a subepithelial tumor (SET) by previous endoscopic ultrasonography (EUS), or possible diagnosis of SET by finding a subepithelial lesion (SEL) in a conventional endoscopy performed that will require a EUS study. * Acceptance by the patient as a candidate of the BANDING-SET study (NCT03247231) of assessment of the effectiveness and safety of band ligation without resection of subepithelial tumors of the digestive tract ≤15-mm, with the prior signing of the Informed Consent of this study. * Patient that understand the concept of the study and will complete all the time frame until the study end EXCLUSION CRITERIA: * No Informed Consent. * No BANDING-SET study (NCT03247231) Informed Consent. * Patients with functional diversity, unable to understand the nature and possible consequences of the study. * Patients unable to maintain subsequent follow-up (lack of adherence). * Patients with a life expectancy of less than 12 months.

Locations (7)

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

Outcomes

Primary Outcomes

Initial Anxiety degree

At 1-2 months, number of patients with a total anxiety score of 8 or more points in the Hospital Anxiety and Depression Scale (HADS), anxiety subescale. Hospital Anxiety and Depression Scale (HADS), anxiety subescale, legend: * 0-7 points: Normal. * 8-10 points: Borderline anxiety. * 11-21 points: Anxiety disorder.

Time frame: 1-2 months

Initial Fear of Cancer degree

At 1-2 months, number of patients with a total fear of cancer score of 11 or more points in the Cancer Worry Scale (CWS). Cancer Worry Scale (CWS) legend: * 6-10 points: Low. * 11-15 points: Moderate. * 16-20 points: High. * 21-24 points: Very high.

Time frame: 1-2 months

Secondary Outcomes

Long-term Anxiety degree

At 1 year, number of patients with a total anxiety score of 8 or more points in the Hospital Anxiety and Depression Scale (HADS), anxiety subescale. Hospital Anxiety and Depression Scale (HADS), anxiety subescale, legend: * 0-7 points: Normal. * 8-10 points: Borderline anxiety. * 11-21 points: Anxiety disorder.

Time frame: 1 year

Long-term Fear of Cancer degree

At 1 year, number of patients with a total fear of cancer score of 11 or more points in the Cancer Worry Scale (CWS). Cancer Worry Scale (CWS) legend: * 6-10 points: Low. * 11-15 points: Moderate. * 16-20 points: High. * 21-24 points: Very high.

Time frame: 1 year

Data from ClinicalTrials.gov

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