Anxiety and Fear of Cancer Before and After Banding Without Resection in Small SET Management (QUALI-BANDING-SET)

Gastrointestinal Subepithelial Tumors Clinical Trial

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04316000
• Other study ID #: QUALI-BANDING-SET
• Status: Suspended
• Start date: November 22, 2019
• Est. completion date: March 2022

Study information

• Verified date: September 2021
• Source: Hospital Universitari de Bellvitge
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Suspended
• Enrollment: 150
• Est. completion date: March 2022
• Est. primary completion date: March 30, 2021
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety Disorders
• Gastrointestinal Subepithelial Tumors

Intervention

Other:
• 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.

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.

Other:
• 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.

Locations

Country	Name	City	State
Spain	Hospital Universitari Germans Trias i Pujol (Can Ruti)	Badalona	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 de Bellvitge	L'Hospitalet de Llobregat	Barcelona, Catalonia
Spain	Hospital Universitari Arnau de Vilanova de Lleida	Lleida	Catalonia
Spain	Hospital Universitari Joan XXIII de Tarragona	Tarragona	Catalonia
Spain	Hospital Universitari Mútua de Terrassa	Terrassa	Barcelona, Catalonia

Sponsors (1)

Lead Sponsor	Collaborator
Francesc Bas-Cutrina

Country where clinical trial is conducted

Spain, 

References & Publications (3)

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 clin — View 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. Spanish. — View Citation

Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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: 0-7 points: Normal.; 8-10 points: Borderline anxiety.; 11-21 points: Anxiety disorder.	1-2 months
Primary	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: 6-10 points: Low.; 11-15 points: Moderate.; 16-20 points: High.; 21-24 points: Very high.	1-2 months
Secondary	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: 0-7 points: Normal.; 8-10 points: Borderline anxiety.; 11-21 points: Anxiety disorder.	1 year
Secondary	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: 6-10 points: Low.; 11-15 points: Moderate.; 16-20 points: High.; 21-24 points: Very high.	1 year