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

Francesc Bas-Cutrina

Status: Suspended

Conditions: Gastrointestinal Subepithelial Tumors

Treatments: Other: Initial Anxiety and Fear of Cancer Test; Other: 1-2 Months Anxiety and Fear of Cancer Test; Procedure: Endoscopic band ligation without resection of the subpetihelial tumour.; Other: 1 Year Anxiety and Fear of Cancer Test

Study type: Observational

Funder types: Other

Identifiers

NCT04316000

QUALI-BANDING-SET

Details and patient eligibility

About

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.

Full 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].

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

150 participants in 3 patient groups

A - Removal of the Subepithelial Tumour

Description:

The subephitelial tumour is successfully removed by endoscopic band ligation without resection.

Treatment:

Other: 1 Year 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: Initial Anxiety and Fear of Cancer Test

B - Non Removal of the Subepithelial Tumour

Description:

The subephitelial tumour is not successfully removed due to various reasons (size \>15-mm, not technical success,...).

Treatment:

Other: 1 Year Anxiety and Fear of Cancer Test

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

Other: Initial Anxiety and Fear of Cancer Test

C - Not Observed or Benign Subepithelial Tumour

Description:

The subephitelial tumour is not observed or is a benign entity, which does not require further interventions for these patients.

Treatment:

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

Other: Initial Anxiety and Fear of Cancer Test