Gastrointestinal Subepithelial TumorsNCT04316000
Anxiety and Fear of Cancer Before and After Banding Without Resection in Small SET Management (QUALI-BANDING-SET)
An observational study of Gastrointestinal Subepithelial Tumors, run by Francesc Bas-Cutrina at 7 sites in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gastrointestinal Subepithelial Tumors
- What is being tested?
- Initial Anxiety and Fear of Cancer Test, Endoscopic band ligation without resection of the subpetihelial tumour. and 1-2 Months Anxiety and Fear of Cancer Test
- Type of treatment
- Surgery or procedure
- How many people
- 150 participants
- Where
- 7 sitesSpain
- Study dates
- 22 Nov 2019to Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Adult, Older adult
Study population: Patients with subepithelial lesions (SEL) in the gastrointestinal tract.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
7 sites in 1 country.
7 sites in 1 country
Spain7 sites
Hospital Universitari Germans Trias i Pujol (Can Ruti)
Badalona, Barcelona, Catalonia, 08916
Hospital de Sant Pau i de la Santa Creu
Barcelona, Catalonia, 08041
Hospital Universitari de Girona Doctor Josep Trueta
Girona, Catalonia, 17007
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Catalonia, 08907
Hospital Universitari Arnau de Vilanova de Lleida
Lleida, Catalonia, 25198
Hospital Universitari Joan XXIII de Tarragona
Tarragona, Catalonia, 43005
Hospital Universitari Mútua de Terrassa
Terrassa, Barcelona, Catalonia, 08221
About this study
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
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.
Read the 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].
- Conditions
- Gastrointestinal Subepithelial Tumors
- Being tested
- Initial Anxiety and Fear of Cancer Test, Endoscopic band ligation without resection of the subpetihelial tumour., 1-2 Months Anxiety and Fear of Cancer Test, 1 Year Anxiety and Fear of Cancer Test
- Keywords
- Tumourophobia, Anxiety for Cancer, Quality of Life, Cancer Worry Scale (CWS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Initial Anxiety and Fear of Cancer TestOther
Also called Initial 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.
Endoscopic band ligation without resection of the subpetihelial tumour.Procedure or surgery
Also called Successful SET banding
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.
1-2 Months Anxiety and Fear of Cancer TestOther
Also called 1-2 Months 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 TestOther
Also called 1 Year 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.
| Study group | Role | What they receive |
|---|---|---|
| A - Removal of the Subepithelial Tumour | The subephitelial tumour is successfully removed by endoscopic band ligation without resection. Receives: 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,...). Receives: 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. Receives: Other: Initial Anxiety and Fear of Cancer Test; Other: 1-2 Months Anxiety and Fear of Cancer Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1-2 months
Secondary outcomes (2)
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.
Measured: 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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2020
- Study start22 Nov 2019
- Primary completion30 Mar 2021
- Study completionMar 2022 (estimated)
Why it stopped: Due to SARS-CoV2 (Covid-19) pandemia and its implications for outcomes bias.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Gastrointestinal Subepithelial TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Francesc Bas-Cutrina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Francesc Bas-Cutrina, Hospital Universitari de Bellvitge
- Investigators
- Francesc Bas-Cutrina, MD, Principal investigator, Endoscopy Unit; Digestive Diseases Department; H. Universitari de Bellvitge.Joan B Gornals, MD, PhD, Principal investigator, Endoscopy Unit; Digestive Diseases Department; H. Universitari de Bellvitge.Sebastià Videla, MD, PhD, Principal investigator, Department of Clinical Pharmacology; H. Universitari de Bellvitge.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04316000
- Sponsor's protocol ID
- QUALI-BANDING-SET
- Status last verified
- Sep 2021
- First submitted
- 16 Mar 2020
- Last updated
- 8 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 6880820Herdman 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.
PubMed 11602124Aaronson 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.
PubMed 8433390
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04316000
- Acronym / sponsor ID
- QUALI-BANDING-SET
- Conditions
- Gastrointestinal Subepithelial Tumors
- Keywords
- Tumourophobia, Anxiety for Cancer, Quality of Life, Cancer Worry Scale (CWS)
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: Due to SARS-CoV2 (Covid-19) pandemia and its implications for outcomes bias.
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Francesc Bas-CutrinaUniversity, hospital or other
- Study start
- 22 Nov 2019 (actual)
- Primary completion
- 30 Mar 2021 (actual)
- Study completion
- Mar 2022 (estimated)
- First posted
- 20 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A - Removal of the Subepithelial Tumour | – | 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 TestThe subephitelial tumour is successfully removed by endoscopic band ligation without resection. |
| B - Non Removal of the Subepithelial Tumour | – | 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 TestThe subephitelial tumour is not successfully removed due to various reasons (size >15-mm, not technical success,...). |
| C - Not Observed or Benign Subepithelial Tumour | – | Other: Initial Anxiety and Fear of Cancer Test, Other: 1-2 Months Anxiety and Fear of Cancer TestThe subephitelial tumour is not observed or is a benign entity, which does not require further interventions for these patients. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with subepithelial lesions (SEL) in the gastrointestinal tract.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Initial Anxiety and Fear of Cancer TestAlso: Initial TestAnswer 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 | 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.Also: Successful SET bandingCorrect application of the elastic band in the subepithelial tumor, achieving its removal by self-amputation in the 4-6 weeks endoscopic ultrasonography (EUS) control. | Procedure or surgery | A - Removal of the Subepithelial Tumour |
| 1-2 Months Anxiety and Fear of Cancer TestAlso: 1-2 Months TestAnswer 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 | 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 TestAlso: 1 Year TestAnswer 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 | A - Removal of the Subepithelial Tumour, B - Non Removal of the Subepithelial Tumour |
Primary outcome
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.
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.
2 secondary outcomes
Long-term Anxiety degree
Time frame: 1 year
Long-term Fear of Cancer degree
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2021.
- Results publication: PubMed 6880820Zigmond 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.
- Results publication: PubMed 11602124Herdman 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.
- Results publication: PubMed 8433390Aaronson 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francesc Bas-Cutrina, MD principal investigator
Endoscopy Unit; Digestive Diseases Department; H. Universitari de Bellvitge.
Joan B Gornals, MD, PhD principal investigator
Endoscopy Unit; Digestive Diseases Department; H. Universitari de Bellvitge.
Sebastià Videla, MD, PhD principal investigator
Department of Clinical Pharmacology; H. Universitari de Bellvitge.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastrointestinal Subepithelial Tumors, run by Francesc Bas-Cutrina at 7 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 8 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Initial Anxiety degree (time frame: 1-2 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04316000, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2021.