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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04316000
Recruitment Status : Suspended (Due to SARS-CoV2 (Covid-19) pandemia and its implications for outcomes bias.)
First Posted : March 20, 2020
Last Update Posted : May 5, 2020
Sponsor:
Information provided by (Responsible Party):
Francesc Bas-Cutrina, Hospital Universitari de Bellvitge

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.

Condition or disease Intervention/treatment
Gastrointestinal Subepithelial Tumors 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].

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : August 28, 2019
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 1-2 Months Test




Primary Outcome Measures :
  1. Initial Anxiety degree [ Time Frame: 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.

  2. Initial Fear of Cancer degree [ Time Frame: 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.


Secondary Outcome Measures :
  1. Long-term Anxiety degree [ Time Frame: 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.

  2. Long-term Fear of Cancer degree [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients with subepithelial lesions (SEL) in the gastrointestinal tract.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04316000


Locations
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Spain
Hospital Universitari Germans Trias i Pujol (Can Ruti)
Badalona, Barcelona, Catalonia, Spain, 08916
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Catalonia, Spain, 08907
Hospital Universitari Mútua de Terrassa
Terrassa, Barcelona, Catalonia, Spain, 08221
Hospital de Sant Pau i de la Santa Creu
Barcelona, Catalonia, Spain, 08041
Hospital Universitari de Girona Doctor Josep Trueta
Girona, Catalonia, Spain, 17007
Hospital Universitari Arnau de Vilanova de Lleida
Lleida, Catalonia, Spain, 25198
Hospital Universitari Joan XXIII de Tarragona
Tarragona, Catalonia, Spain, 43005
Sponsors and Collaborators
Francesc Bas-Cutrina
Investigators
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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 of Results:
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Responsible Party: Francesc Bas-Cutrina, Principal Investigator, Hospital Universitari de Bellvitge
ClinicalTrials.gov Identifier: NCT04316000    
Other Study ID Numbers: QUALI-BANDING-SET
First Posted: March 20, 2020    Key Record Dates
Last Update Posted: May 5, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Francesc Bas-Cutrina, Hospital Universitari de Bellvitge:
Tumourophobia
Anxiety for Cancer
Quality of Life
Cancer Worry Scale (CWS)
Additional relevant MeSH terms:
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Anxiety Disorders
Mental Disorders