Clinical trial NCT06921863: 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.
Official title: Decisional Regret Following Radiotherapy Against Cancer With Poor to Excellent Prognosis
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Quality of Life (QOL)
Decision Making ,Shared
Keywords: Decisional Regret
Radiotherapy
Quality of Life
Lead sponsor: University Medical Center Goettingen
Sponsor class: OTHER
First posted: 2025-04-10
Enrollment: 165
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Cohort 1: Patients with low-risk cancers Cohort 2: Patients with cancers in the intermediate and high risk profile Cohort 3: Patients with high symptom burden

Brief summary: 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.

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

Primary outcomes:
measure: Decisional Regret
timeFrame: from enrollment to the end of routinely performed clinical follow-up examinations after 5 yeasr after RT start
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
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: