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.

NCT06921863 | Not Yet Recruiting

• 1 other identifier: 11/3/25
• Study Type: observational
• Target: 165
• Locations: 0 countries
• Sites: N/A

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

Conditions

Quality of Life (QOL); Decision Making ,Shared

Keywords

Decisional Regret; Radiotherapy; Quality of Life

Outcome Measures

Primary Outcomes (2)

• 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).

  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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Indication for radiotherapy
• Patient information and declaration of consent
• Patients age ≥ 18 years

You may not qualify if:

• 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

Sponsors & Collaborators

• University Medical Center Goettingen: lead

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. med. Stephanie Bendrich

Study Record Dates

• First Submitted: March 11, 2025
• First Posted: April 10, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): October 1, 2029
• Study Completion (Estimated): October 1, 2032
• Last Updated: April 10, 2025

Record last verified: 2025-04