Anxiety and Fear of Cancer Before and After Banding Without Resection in Small SET Management (QUALI-BANDING-SET)
- Conditions
- Gastrointestinal Subepithelial Tumors
- Registration Number
- NCT04316000
- Lead Sponsor
- Francesc Bas-Cutrina
- 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 \[hypothesis: anxiety and fear of cancer should decrease\].
Recruitment & Eligibility
- Status
- SUSPENDED
- Sex
- All
- Target Recruitment
- 150
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Initial Fear of Cancer degree 1-2 months 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.Initial Anxiety degree 1-2 months 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.
- Secondary Outcome Measures
Name Time Method Long-term Anxiety degree 1 year 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.Long-term Fear of Cancer degree 1 year 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.
Trial Locations
- Locations (7)
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
Hospital Universitari Germans Trias i Pujol (Can Ruti)🇪🇸Badalona, Barcelona, Catalonia, Spain