Anxiety and Fear of Cancer Before and After Banding Without Resection in Small SET Management (QUALI-BANDING-SET)
NCT ID: NCT04316000
Last Updated: 2021-09-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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SUSPENDED
150 participants
OBSERVATIONAL
2019-11-22
2022-03-31
Brief Summary
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Detailed Description
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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 \[hypothesis: anxiety and fear of cancer should decrease\].
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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A - Removal of the Subepithelial Tumour
The subephitelial tumour is successfully removed by endoscopic band ligation without resection.
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.
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.
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.
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.
B - Non Removal of the Subepithelial Tumour
The subephitelial tumour is not successfully removed due to various reasons (size \>15-mm, not technical success,...).
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.
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.
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.
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.
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.
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.
Interventions
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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.
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.
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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
80 Years
ALL
No
Sponsors
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Francesc Bas-Cutrina
OTHER
Responsible Party
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Francesc Bas-Cutrina
Principal Investigator
Principal Investigators
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Francesc Bas-Cutrina, MD
Role: PRINCIPAL_INVESTIGATOR
Endoscopy Unit; Digestive Diseases Department; H. Universitari de Bellvitge.
Joan B Gornals, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Endoscopy Unit; Digestive Diseases Department; H. Universitari de Bellvitge.
Sebastià Videla, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Clinical Pharmacology; H. Universitari de Bellvitge.
Locations
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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
Countries
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References
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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.
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.
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.
Other Identifiers
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QUALI-BANDING-SET
Identifier Type: -
Identifier Source: org_study_id
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