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

Study Overview
=================
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].

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

Conditions
-----------------
Gastrointestinal Subepithelial Tumors

Intervention / Treatment
-----------------
* Other: Initial Anxiety and Fear of Cancer Test
* Procedure: Endoscopic band ligation without resection of the subpetihelial tumour.
* Other: 1-2 Months Anxiety and Fear of Cancer Test
* Other: 1 Year Anxiety and Fear of Cancer Test


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| A - Removal of the Subepithelial Tumour<br>The subephitelial tumour is successfully removed by endoscopic band ligation without resection. | Other: Initial Anxiety and Fear of Cancer Test<br>* 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.<br>* Other names: Initial Test;Procedure: Endoscopic band ligation without resection of the subpetihelial tumour.<br>* 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.<br>* Other names: Successful SET banding;Other: 1-2 Months Anxiety and Fear of Cancer Test<br>* 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.<br>* Other names: 1-2 Months Test;Other: 1 Year Anxiety and Fear of Cancer Test<br>* 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.<br>* Other names: 1 Year Test;|
| B - Non Removal of the Subepithelial Tumour<br>The subephitelial tumour is not successfully removed due to various reasons (size >15-mm, not technical success,...). | Other: Initial Anxiety and Fear of Cancer Test<br>* 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.<br>* Other names: Initial Test;Other: 1-2 Months Anxiety and Fear of Cancer Test<br>* 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.<br>* Other names: 1-2 Months Test;Other: 1 Year Anxiety and Fear of Cancer Test<br>* 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.<br>* Other names: 1 Year Test;|
| C - Not Observed or Benign Subepithelial Tumour<br>The subephitelial tumour is not observed or is a benign entity, which does not require further interventions for these patients. | Other: Initial Anxiety and Fear of Cancer Test<br>* 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.<br>* Other names: Initial Test;Other: 1-2 Months Anxiety and Fear of Cancer Test<br>* 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.<br>* Other names: 1-2 Months Test;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 1-2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tumourophobia, Anxiety for Cancer, Quality of Life, Cancer Worry Scale (CWS)