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.

N/ANot Yet RecruitingNCT06921863

University Medical Center Goettingen165 enrolled

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

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.

Study Type

OBSERVATIONAL

Enrollment

165

Conditions

Quality of Life (QOL)Decision Making ,Shared

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Decisional Regret

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).

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

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.

Time frame: from enrollment to the end of routinely performed clinical follow-up examinations after 5 yeasr after RT start