Clinical trial · Observational
This Study Aims to Quantify Decisional Regret as Well as Quality of Life in Patients With Low- to High-risk Cancer and High Burden of Symptoms Undergoing Radiotherapy Using Established Questionnaires.
Decisional Regret Following Radiotherapy Against Cancer With Poor to Excellent Prognosis
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
In this prospective registry study, patients with low-, intermediate- and high-risk tumor entities as well as patients with high symptom burden of any tumor entity in palliative constellation with indication for radiation treatment are included. This radiation treatment can be applied either as 3D-conformal RT or IGRT. The duration of treatment can range from one day to several weeks. For the primary endpoint as well as the secondary clinical and other exploratory endpoints, the 3 groups will be compared in terms of DR, QoL, toxicities and treatment plan parameters
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Decision Making ,Shared | — | UNRESOLVED | — |
| Quality of Life (QOL) | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Decisional Regret
- timeFrame
- from enrollment to the end of routinely performed clinical follow-up examinations after 5 yeasr after RT start
- description
- Decisional Regret (DR) is measured by the German version of the Ottawa Decisional Regret Scale (Rühle et al. 2014) by answering the comprising 5 questions. Responses are provided on a five-point Likert scale. Decision regret is categorized as absent (0 points), mild (1-25 points) and strong (\>25 points).
- measure
- Quality of Life after Radiotherapy
- timeFrame
- from enrollment to the end of routinely performed clinical follow-up examinations after 5 yeasr after RT start
- description
- Quality of Life is measured using the 80 question comprising PRO-CTCAE questionnaire version 1.0 (Hagelstein et al 2016) , the 30 question comprising EORTC QLQC30 questionnaire version 3.0 and the PSQ-18 questionnaire (Thayaparan and Mahdi 2013). All questionnaires have been previously validated in other publications.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Indication for radiotherapy * Patient information and declaration of consent * Patients age ≥ 18 years Exclusion Criteria: * previous radiotherapy in affected site or same localisation in group 1-3 * Inability to answer the questionnaires * Pre-existing conditions with increased risk of acute or late toxicity (LiFraumeni, Crohn's disease, ulcerative colitis) * Simultaneous participation in other studies that could interfere with this study and/or participation before expiry of a required restriction period * Persons who are in a dependent/employment relationship with the investigator
References
Publications (0)
Data not yet available