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.

ConditionsQuality of Life (QOL)Decision Making ,Shared

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorUniversity Medical Center Goettingen

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Indication for radiotherapy

Patient information and declaration of consent

Patients age ≥ 18 years

Disqualifiers

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

Trial 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

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial 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

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Medical Center Goettingen

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: