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.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Quality of Life (QOL), Decision Making ,Shared. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Decisional Regret Following Radiotherapy Against Cancer With Poor to Excellent Prognosis
Overview
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
Detailed description
Decisional regret and quality of life are quantified and analyzed using general linear models (e.g. linear regression models, ANOVA), taking into account covariates such as tumor stage, application of further systemic therapies, extent of the radiation area, occurrence of acute and/or late side effects. Survival time analyses and tumor control rates are evaluated using Kaplan- Meyer and Cox regression. Technical endpoints, quality of life and patient satisfaction will be described descriptively and compared between the cohorts using a mixed linear model.
Primary outcome measures
- Decisional Regret [Time frame: from enrollment to the end of routinely performed clinical follow-up examinations after 5 yeasr after RT start]
- Quality of Life after Radiotherapy [Time frame: from enrollment to the end of routinely performed clinical follow-up examinations after 5 yeasr after RT start]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06921863 · 11/3/25