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

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.

Study Overview

• Status: Suspended
• Conditions: Gastrointestinal Subepithelial Tumors
• Intervention / Treatment: 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

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].

• Study Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Catalonia
    • Badalona, Barcelona, Catalonia, Spain, 08916
      • Hospital Universitari Germans Trias i Pujol (Can Ruti)
    • L'Hospitalet de Llobregat, Barcelona, Catalonia, Spain, 08907
      • Hospital Universitari de Bellvitge
    • Terrassa, Barcelona, Catalonia, Spain, 08221
      • Hospital Universitari Mutua de Terrassa
  • Catalonia
    • Barcelona, Catalonia, Spain, 08041
      • Hospital de Sant Pau i de la Santa Creu
    • Girona, Catalonia, Spain, 17007
      • Hospital Universitari de Girona Doctor Josep Trueta
    • Lleida, Catalonia, Spain, 25198
      • Hospital Universitari Arnau de Vilanova de Lleida
    • Tarragona, Catalonia, Spain, 43005
      • Hospital Universitari Joan Xxiii de Tarragona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with subepithelial lesions (SEL) in the gastrointestinal tract.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
A - Removal of the Subepithelial Tumour; The subephitelial tumour is successfully removed by endoscopic band ligation without resection.	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.; Other Names: Initial Test; 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 Names: Successful SET banding; 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.; Other Names: 1-2 Months Test; Other: 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 Names: 1 Year Test
B - Non Removal of the Subepithelial Tumour; The subephitelial tumour is not successfully removed due to various reasons (size >15-mm, not technical success,...).	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.; Other Names: Initial Test; 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.; Other Names: 1-2 Months Test; Other: 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 Names: 1 Year Test
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.	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.; Other Names: Initial Test; 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.; Other Names: 1-2 Months Test

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Francesc Bas-Cutrina
• Investigators: Principal Investigator: Francesc Bas-Cutrina, MD, Endoscopy Unit; Digestive Diseases Department; H. Universitari de Bellvitge.; Principal Investigator: Joan B Gornals, MD, PhD, Endoscopy Unit; Digestive Diseases Department; H. Universitari de Bellvitge.; Principal Investigator: Sebastià Videla, MD, PhD, Department of Clinical Pharmacology; H. Universitari de Bellvitge.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 22, 2019
• Primary Completion (Actual): March 30, 2021
• Study Completion (Anticipated): March 1, 2022

Study Registration Dates

• First Submitted: March 16, 2020
• First Submitted That Met QC Criteria: March 18, 2020
• First Posted (Actual): March 20, 2020

Study Record Updates

• Last Update Posted (Actual): September 8, 2021
• Last Update Submitted That Met QC Criteria: September 5, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Quality of Life; Tumourophobia; Anxiety for Cancer; Cancer Worry Scale (CWS)
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: QUALI-BANDING-SET

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No