Clinical trial · Observational
Anxiety and Fear of Cancer Before and After Banding Without Resection in Small SET Management (QUALI-BANDING-SET)
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
NCT04316000CI-TRIAL-00053743suspendedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Due to SARS-CoV2 (Covid-19) pandemia and its implications for outcomes bias.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastrointestinal Subepithelial Tumors | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 1-2 Months Anxiety and Fear of Cancer Test | Other | — | UNRESOLVED |
| 1 Year Anxiety and Fear of Cancer Test | Other | — | UNRESOLVED |
| Endoscopic band ligation without resection of the subpetihelial tumour. | Procedure | — | UNRESOLVED |
| Initial Anxiety and Fear of Cancer Test | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- A - Removal of the Subepithelial Tumour
- description
- The subephitelial tumour is successfully removed by endoscopic band ligation without resection.
- interventionNames
- 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
- label
- B - Non Removal of the Subepithelial Tumour
- description
- The subephitelial tumour is not successfully removed due to various reasons (size \>15-mm, not technical success,...).
- interventionNames
- Other: Initial Anxiety and Fear of Cancer Test
- Other: 1-2 Months Anxiety and Fear of Cancer Test
- Other: 1 Year Anxiety and Fear of Cancer Test
- label
- C - Not Observed or Benign Subepithelial Tumour
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (3)
- RESULTZigmond 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. PMID 6880820
- RESULTHerdman 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. PMID 11602124
- RESULTAaronson 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. PMID 8433390