Surgery as needed versus surgery on principle in patients with post-neoadjuvant complete response of esophageal cancer (ESORES) - PILOT STUDY on Patient Participation
Organizational Data
- DRKS-ID:
- DRKS00022050
- Recruitment Status:
- Recruiting complete, study complete
- Date of registration in DRKS:
- 2020-10-15
- Last update in DRKS:
- 2024-01-18
- Registration type:
- Prospective
Acronym/abbreviation of the study
ESORES
URL of the study
https://www.uniklinik-freiburg.de/cccf/forschung/selbsthilfeforschung.html
Brief summary in lay language
Aim of the study is to develop study information material for a study, in which two treatments for esophageal cancer will be compared. The first phase includes the development of a "preference and decision aid questionnaire" (PDAQ) to survey information needs, expectations, and fears concerning treatment options for patients with esophageal cancer. This questionnaire is based on interviews with one focus group with 3-5 patients and 5-7 single interviews. Moreover, there will be 10 expert interviews with physicians, psychooncologists, or nurses plus with 2 members of self-help groups that focus on other disorders but with similiar symptoms to also include their opinion. In the second phase of the study the PDAQ is given to 120 esophageal cancer patients to develop the study information material. In addition, it will be analyzed which sociodemographic (e.g., age, gender) and psychosocial factors (e.g., depressive symptoms, anxiety of recurrence) affect the patients' treatment preferences. In this phase also the hypotheses for the calculation of the sample in the main study will be checked and informations about the probability that patients accept the participation and the randomization will be obtained.
Brief summary in scientific language
Aim of the study is to develop RCT-study information material for a study, in which two treatments for esophageal cancer will be compared. The first phase includes the development of a "preference and decision aid questionnaire" (PDAQ) to survey information needs, expectations, and fears concerning treatment options for patients with esophageal cancer. This questionnaire is based on interviews with one focus group with 3-5 patients and 5-7 single interviews. Moreover, there will be 10 expert interviews with physicians, psychooncologists, or nurses plus with 2 members of self-help groups that focus on other disorders but with similiar symptoms to also include their opinion. In the second phase of the study the PDAQ is given to 120 esophageal cancer patients to develop the study information material. In addition, it will be analyzed which sociodemographic (e.g., age, gender) and psychosocial factors (e.g., depressive symptoms, anxiety of recurrence) affect the patients' treatment preferences. In this phase also the hypotheses for the calculation of the sample in the main study will be checked and informations about the probability that patients accept the participation and the randomization will be obtained.
Health condition or problem studied
- ICD10:
- C15 - Malignant neoplasm of oesophagus
- Healthy volunteers:
- No
Interventions, Observational Groups
- Arm 1:
- After neoadjuvant chemotherapy or radiochemotherapy plus surgery, esophageal cancer patients are interviewed about their preferences, fears and needs in order to develop patient information material for a later RCT.
Endpoints
- Primary outcome:
- To develop patient-centered study information material and a check-list that supports medical staff at the study information process
- Secondary outcome:
- none
Study Design
- Purpose:
- Supportive care
- Retrospective/prospective:
- No Entry
- Study type:
- Non-interventional
- Longitudinal/cross-sectional:
- No Entry
- Study type non-interventional:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting complete, study complete
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Multicenter study
- Recruitment location(s):
-
- University medical center Universitätsklinikum Freiburg Freiburg im Breisgau
- University medical center Universitätsklinikum Schleswig-Holstein, Campus Lübeck Lübeck
- University medical center Universitätsmedizin Mainz Mainz
- University medical center Universitätsklinikum Hamburg-Eppendorf Hamburg
- University medical center Uniklinik Köln Köln
- University medical center Universitätsklinikum Schleswig-Holstein, Campus Kiel Kiel
Recruitment period and number of participants
- Planned study start date:
- 2022-06-01
- Actual study start date:
- 2022-08-23
- Planned study completion date:
- 2023-12-31
- Actual Study Completion Date:
- 2023-12-31
- Target Sample Size:
- 120
- Final Sample Size:
- 73
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- no maximum age
- Additional Inclusion Criteria:
- Diagnosis of non-metastatic esophageal cancer (including both epidemiologically relevant histologies of EC [EAC and ESCC] according to the UICC definition; Scheduled or running treatment by western standard of care multimodal treatment schemes [nCT plus surgery and nCRT plus surgery]); Age > 18 years; Patients before surgery; Ability to read and understand German; Willingness and ability to give informed consent before study entry; Patient's written informed consent has been obtained.
Exclusion Criteria
No written consent available; Patients with gastric cancer; Patients with tumors of the cervical esophagus; Co-morbidity with contraindication for esophageal surgery; Patient without legal capacity who is unable to understand the nature, significance and consequences of the study; Concurrent medical or psychiatric condition that might preclude participation in the study according to investigator assessment; Cognitive or other type of impairment (such as severe psychiatric disorders and severe cognitive disorders that would interfere with completing paper-pencil questionnaires; Simultaneous participation in other studies which could interfere with this study and/or participation before the end of a required restriction period.
Addresses
Primary Sponsor
- Address:
- Universitätsklinikum Schleswig-HolsteinCampus LübeckProf. Dr. med. Jens HoeppnerRatzeburger Allee 16023538 LübeckGermany
- Telephone:
- 0451 500-40100
- Fax:
- 0451 500-40104
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.uksh.de/
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Professur für Selbsthilfeforschung, Comprehensive Cancer Center Freiburg, Universitätsklinikum FreiburgProf. Dr. Joachim WeisHugstetter Str. 4979106 FreiburgGermany
- Telephone:
- +49-761-270-71561
- Fax:
- +49 (0)761 270-71569
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.uniklinik-freiburg.de/cccf/forschung/selbsthilfeforschung.html
Contact for Public Queries
- Address:
- Professur für Selbsthilfeforschung, Comprehensive Cancer Center Freiburg, Universitätsklinikum FreiburgProf. Dr. Joachim WeisHugstetter Str. 4979106 FreiburgGermany
- Telephone:
- +49-761-270-71561
- Fax:
- +49 (0)761 270-71569
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.uniklinik-freiburg.de/cccf/forschung/selbsthilfeforschung.html
Principal Investigator
- Address:
- Professur für Selbsthilfeforschung, Comprehensive Cancer Center Freiburg, Universitätsklinikum FreiburgProf. Dr. Joachim WeisHugstetter Str. 4979106 FreiburgGermany
- Telephone:
- +49-761-270-71561
- Fax:
- +49 (0)761 270-71569
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.uniklinik-freiburg.de/cccf/forschung/selbsthilfeforschung.html
Sources of Monetary or Material Support
Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)
- Address:
- Bundesministerium für Bildung und Forschung Dienstsitz Bonn Förderkennzeichen: 01KD2205BHeinemannstr. 253175 BonnGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.bmbf.de
Ethics Committee
Address Ethics Committee
- Address:
- Ethik-Kommission der Albert-Ludwigs-Universität FreiburgEngelberger Str. 2179106 FreiburgGermany
- Telephone:
- +49-761-27072600
- Fax:
- +49-761-27072630
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2020-07-27
- Ethics committee number:
- 20-1037_1
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2020-09-29
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
- Other secondary IDs:
- 01KD2205B - Förderkennzeichen BMBF
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- Weis J, Kiemen A, Schmoor C, Hipp J, Czornik M, Reeh M, Grimminger PP, Bruns C, Hoeppner J. Study Protocol of a Prospective Multicenter Study on Patient Participation for the Clinical Trial: Surgery as Needed Versus Surgery on Principle in Post-Neoadjuvant Complete Tumor Response of Esophageal Cancer (ESORES). Front Oncol. 2022 Jan 18;11:789155. doi: 10.3389/fonc.2021.789155. PMID: 35117993; PMCID: PMC8803636.
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry