SeniorValue-Based AsNCT07481994
Changes in Value-Based Assessment in Patients Undergoing Major Oncological Surgery
An observational study of Senior and Oncologic Disease, run by Tomas Bata Hospital, Czech Republic at 1 site in Czechia.
Trial summary
Introduction The study focuses on analyzing the level of awareness among oncological patients, their perception of their health status, and expectations regarding radical surgical intervention. Read more about this study
- Who is it for?
- Ages 65 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Senior, Oncologic Disease
- How many people
- 100 participants
- Where
- 1 siteCzechia
- Study dates
- 11 Oct 2024to 20 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 65 to 100 years
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Older adults aged 65 and above undergoing surgical procedures with oncological diagnosis.
Who may be able to join
- • Age ≥ 65 years
- Type of procedure: hemicolectomy, rectal amputation, cystectomy, extensive nephrectomy, malignant brain tumor
- ASA classification III
- No sensory impairment (blindness, deafness, deaf-muteness)
- Patients had access to sensory aids (glasses) during assessment
- No legal incapacity
Show all 9Show fewer
- Consent to participate in the study
- Signed informed consent
- Postoperative hospitalization in the ICU (anticipated during pre-anesthetic examination)
Who cannot join
- • Glasgow Coma Scale ≤ 14
- Somnolence, coma
- Known psychiatric disorder
- Effect of premedication, psychiatric or analgesic-sedative drugs during cognitive function assessment
Trial locations and contacts
1 site in 1 country.
About this study
Introduction The study focuses on analyzing the level of awareness among oncological patients, their perception of their health status, and expectations regarding radical surgical intervention. It assesses changes in patients' attitudes toward their diagnosis, therapeutic options, and prognosis both preoperatively and postoperatively. The research involves a systematic collection of value-based medical history through structured interviews, enabling the identification of key factors influencing patient experience and decision-making processes in oncological treatment.
Read the detailed description
The study is particularly focused on collecting patients' value-based medical history before and immediately after surgery. Respondents must meet specific inclusion criteria to undergo surgical procedures classified as BUPA D-hemicolectomy, rectal resection, urological surgery (cystectomy or radical nephrectomy), or resection of malignant brain tumors. Patients scheduled for surgical intervention initially underwent an assessment in the anesthesiology clinic, where they were informed about the possibility of participating in the study. Upon signing the informed consent, the collection of their value-based medical history commenced. Following surgery and prior to discharge from the intensive care unit (ICU), a subsequent interview was conducted, during which responses were compared and potential changes in personal attitudes were evaluated [1,2, 3].
The value-based medical history was obtained following a predefined set of questions. The aim of the study is to determine whether collecting value-based medical history reveals patients' level of awareness regarding their illness, their expectations, and any shifts in attitudes after surgery and hospitalization in the ICU at ARIM KNTB Zlín. The findings may indicate further hypotheses related to the collection of value-based medical history.
- Conditions
- Senior, Oncologic Disease
- Keywords
- senior
What is being measured
The primary outcome is the main question the study is designed to answer.
Understanding of illness
- What do you know about your health condition?
- How do you understand it?
Measured: one week before surgery
Identification of a close person
- With whom do you discuss important life matters?
- Who could think or decide for you?
Measured: one week before surgery
Patient values and preferences
What is important to you in life? Besides the surgery, what else do you think about?
Measured: one week before surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2026
- Study start11 Oct 2024
- Primary completion11 Nov 2027 (estimated)
- Study completion20 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SeniorStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tomas Bata Hospital, Czech Republic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Turek Radovan, Tomas Bata Hospital, Czech Republic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07481994
- Sponsor's protocol ID
- ARIM Tomas Bata Hospital Zlin
- Other IDs
- Radovan Turek
- Acronym
- Value-Based As
- Status last verified
- Mar 2026
- First submitted
- 15 Mar 2026
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Value-Based Assessment in Patients Undergoing Major Oncological Surgery
- ClinicalTrials.gov ID
- NCT07481994
- Acronym / sponsor ID
- Value-Based As / ARIM Tomas Bata Hospital Zlin
- Conditions
- Senior, Oncologic Disease
- Keywords
- senior
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Tomas Bata Hospital, Czech RepublicUniversity, hospital or other
- Study start
- 11 Oct 2024 (actual)
- Primary completion
- 11 Nov 2027 (estimated)
- Study completion
- 20 Dec 2027 (estimated)
- First posted
- 19 Mar 2026 (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.
Introduction The study focuses on analyzing the level of awareness among oncological patients, their perception of their health status, and expectations regarding radical surgical intervention. It assesses changes in patients' attitudes toward their diagnosis, therapeutic options, and prognosis both preoperatively and postoperatively. The research involves a systematic collection of value-based medical history through structured interviews, enabling the identification of key factors influencing patient experience and decision-making processes in oncological treatment.
Detailed description
The study is particularly focused on collecting patients' value-based medical history before and immediately after surgery. Respondents must meet specific inclusion criteria to undergo surgical procedures classified as BUPA D-hemicolectomy, rectal resection, urological surgery (cystectomy or radical nephrectomy), or resection of malignant brain tumors. Patients scheduled for surgical intervention initially underwent an assessment in the anesthesiology clinic, where they were informed about the possibility of participating in the study. Upon signing the informed consent, the collection of their value-based medical history commenced. Following surgery and prior to discharge from the intensive care unit (ICU), a subsequent interview was conducted, during which responses were compared and potential changes in personal attitudes were evaluated [1,2, 3].
The value-based medical history was obtained following a predefined set of questions. The aim of the study is to determine whether collecting value-based medical history reveals patients' level of awareness regarding their illness, their expectations, and any shifts in attitudes after surgery and hospitalization in the ICU at ARIM KNTB Zlín. The findings may indicate further hypotheses related to the collection of value-based medical history.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Older adults aged 65 and above undergoing surgical procedures with oncological diagnosis.
Key inclusion criteria (9 listed)
- • Age ≥ 65 years
Key exclusion criteria (4 listed)
- • Glasgow Coma Scale ≤ 14
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Understanding of illness
Time frame: one week before surgery
1. What do you know about your health condition? 2. How do you understand it?
Identification of a close person
Time frame: one week before surgery
* With whom do you discuss important life matters? * Who could think or decide for you?
Patient values and preferences
Time frame: one week before surgery
What is important to you in life? Besides the surgery, what else do you think about?
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Senior and Oncologic Disease, run by Tomas Bata Hospital, Czech Republic at 1 site in Czechia.
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 9 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. 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?
This study is still under way. Results are not available in the source record yet.
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?
Understanding of illness (time frame: one week before surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Mar 2026.