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

NCT04316000 | Suspended

• 1 other identifier: QUALI-BANDING-SET
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 7

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.

Conditions

Gastrointestinal Subepithelial Tumors

Keywords

Tumourophobia; Anxiety for Cancer; Quality of Life; Cancer Worry Scale (CWS)

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Long-term Anxiety degree

  1 year

• Long-term Fear of Cancer degree

  1 year

Study Arms (3)

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; 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

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; Other: 1-2 Months Anxiety and Fear of Cancer Test; Other: 1 Year Anxiety and Fear of Cancer 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; Other: 1-2 Months Anxiety and Fear of Cancer Test

Interventions

Initial Anxiety and Fear of Cancer Test OTHER

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.

Also known as: Initial Test

A - Removal of the Subepithelial Tumour; B - Non Removal of the Subepithelial Tumour; C - Not Observed or Benign Subepithelial Tumour

Endoscopic band ligation without resection of the subpetihelial tumour. PROCEDURE

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.

Also known as: Successful SET banding

A - Removal of the Subepithelial Tumour

1-2 Months Anxiety and Fear of Cancer Test OTHER

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.

Also known as: 1-2 Months Test

A - Removal of the Subepithelial Tumour; B - Non Removal of the Subepithelial Tumour; C - Not Observed or Benign Subepithelial Tumour

1 Year Anxiety and Fear of Cancer Test OTHER

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.

Also known as: 1 Year Test

A - Removal of the Subepithelial Tumour; B - Non Removal of the Subepithelial Tumour

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Francesc Bas-Cutrina: lead

Study Sites (7)

Hospital Universitari Germans Trias i Pujol (Can Ruti)

Badalona, Barcelona, Catalonia, 08916, Spain

Location

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, Catalonia, 08907, Spain

Location

Hospital Universitari Mútua de Terrassa

Terrassa, Barcelona, Catalonia, 08221, Spain

Location

Hospital de Sant Pau i de la Santa Creu

Barcelona, Catalonia, 08041, Spain

Location

Hospital Universitari de Girona Doctor Josep Trueta

Girona, Catalonia, 17007, Spain

Location

Hospital Universitari Arnau de Vilanova de Lleida

Lleida, Catalonia, 25198, Spain

Location

Hospital Universitari Joan XXIII de Tarragona

Tarragona, Catalonia, 43005, Spain

Location

Related Publications (3)

• 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.

  PMID: 6880820 RESULT

• 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.

  PMID: 11602124 RESULT

• 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.

  PMID: 8433390 RESULT

Study Officials

• 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.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 16, 2020
• First Posted: March 20, 2020
• Study Start: November 22, 2019
• Primary Completion: March 30, 2021
• Study Completion: March 1, 2022
• Last Updated: September 8, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (7)