Clinical trial NCT04316000: Anxiety and Fear of Cancer Before and After Banding Without Resection in Small SET Management (QUALI-BANDING-SET)
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
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Gastrointestinal Subepithelial Tumors
Keywords: Tumourophobia
Anxiety for Cancer
Quality of Life
Cancer Worry Scale (CWS)
Lead sponsor: Hospital Universitari de Bellvitge
Sponsor class: OTHER
First posted: 2020-03-20
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with subepithelial lesions (SEL) in the gastrointestinal tract.

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

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.

Primary outcomes:
measure: Initial Anxiety degree
timeFrame: 1-2 months
measure: Initial Fear of Cancer degree
timeFrame: 1-2 months
Secondary outcomes:
measure: Long-term Anxiety degree
timeFrame: 1 year
measure: Long-term Fear of Cancer degree
timeFrame: 1 year
Other outcomes:
Locations:
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trias i Pujol (Can Ruti)
state: Barcelona, Catalonia
city: L'Hospitalet de Llobregat
country: Spain
facility: Hospital Universitari de Bellvitge
state: Barcelona, Catalonia
city: Terrassa
country: Spain
facility: Hospital Universitari Mútua de Terrassa
state: Barcelona, Catalonia
city: Barcelona
country: Spain
facility: Hospital de Sant Pau i de la Santa Creu
state: Catalonia
city: Girona
country: Spain
facility: Hospital Universitari de Girona Doctor Josep Trueta
state: Catalonia
city: Lleida
country: Spain
facility: Hospital Universitari Arnau de Vilanova de Lleida
state: Catalonia
city: Tarragona
country: Spain
facility: Hospital Universitari Joan XXIII de Tarragona
state: Catalonia
Study officials:
affiliation: Endoscopy Unit; Digestive Diseases Department; H. Universitari de Bellvitge.
name: Francesc Bas-Cutrina, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Endoscopy Unit; Digestive Diseases Department; H. Universitari de Bellvitge.
name: Joan B Gornals, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Clinical Pharmacology; H. Universitari de Bellvitge.
name: Sebastià Videla, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.