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NCT Number: NCT07481994

Changes in Value-Based Assessment in Patients Undergoing Major Oncological Surgery

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.

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This study is active but is not currently recruiting participants.

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Key information

Age range

65 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Tomas Bata regional Hospital

Zlín, 76001, Czechia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • • 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
  • Consent to participate in the study
  • Signed informed consent
  • Postoperative hospitalization in the ICU (anticipated during pre-anesthetic examination)

Exclusion criteria

  • • Glasgow Coma Scale ≤ 14
  • Somnolence, coma
  • Known psychiatric disorder
  • Effect of premedication, psychiatric or analgesic-sedative drugs during cognitive function assessment

Treatment and study plan

Primary outcomes

  1. Understanding of illness

    Time frame: one week before surgery

    • What do you know about your health condition?
    • How do you understand it?
  2. 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?
  3. 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?

Sponsors and collaborators

Lead sponsor

Tomas Bata Hospital, Czech Republic

Other

Registry information

Acronym: Value-Based As

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Mar 19, 2026
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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