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Due to SARS-CoV2 (Covid-19) pandemia and its implications for outcomes bias.
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A - Removal of the Subepithelial Tumour | The subephitelial tumour is successfully removed by endoscopic band ligation without resection. |
| |
| B - Non Removal of the Subepithelial Tumour | The subephitelial tumour is not successfully removed due to various reasons (size >15-mm, not technical success,...). |
| |
| C - Not Observed or Benign Subepithelial Tumour | The subephitelial tumour is not observed or is a benign entity, which does not require further interventions for these patients. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Initial Anxiety and Fear of Cancer Test | Other | 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. |
| 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:
| 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:
| 1-2 months |
| 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:
| 1 year |
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INCLUSION CRITERIA:
EXCLUSION CRITERIA:
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Patients with subepithelial lesions (SEL) in the gastrointestinal tract.
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| Name | Affiliation | Role |
|---|---|---|
| Francesc Bas-Cutrina, MD | Endoscopy Unit; Digestive Diseases Department; H. Universitari de Bellvitge. | Principal Investigator |
| Joan B Gornals, MD, PhD | Endoscopy Unit; Digestive Diseases Department; H. Universitari de Bellvitge. | Principal Investigator |
| SebastiĂ Videla, MD, PhD | Department of Clinical Pharmacology; H. Universitari de Bellvitge. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitari Germans Trias i Pujol (Can Ruti) | Badalona | Barcelona, Catalonia | 08916 | Spain | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 6880820 | Result | Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x. | |
| 11602124 | Result | Herdman M, Badia X, Berra S. [EuroQol-5D: a simple alternative for measuring health-related quality of life in primary care]. Aten Primaria. 2001 Oct 15;28(6):425-30. doi: 10.1016/s0212-6567(01)70406-4. No abstract available. Spanish. |
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| 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. |
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| 1-2 Months Anxiety and Fear of Cancer Test | Other | 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. |
|
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| 1 Year Anxiety and Fear of Cancer Test | Other | 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. |
|
|
| 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:
| 1 year |
| Hospital Universitari de Bellvitge |
| L'Hospitalet de Llobregat |
| Barcelona, Catalonia |
| 08907 |
| Spain |
| Hospital Universitari MĂștua de Terrassa | Terrassa | Barcelona, Catalonia | 08221 | Spain |
| Hospital de Sant Pau i de la Santa Creu | Barcelona | Catalonia | 08041 | Spain |
| Hospital Universitari de Girona Doctor Josep Trueta | Girona | Catalonia | 17007 | Spain |
| Hospital Universitari Arnau de Vilanova de Lleida | Lleida | Catalonia | 25198 | Spain |
| Hospital Universitari Joan XXIII de Tarragona | Tarragona | Catalonia | 43005 | Spain |
| 8433390 | Result | Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, de Haes JC, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993 Mar 3;85(5):365-76. doi: 10.1093/jnci/85.5.365. |