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.

NCT ID: NCT06921863

Last Updated: 2025-04-10

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 165 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-07-01
• Study Completion Date: 2032-10-01

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.

Conditions

Quality of Life (QOL); Decision Making ,Shared

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Medical Center Goettingen

OTHER

Sponsor Role: lead

Responsible Party

Dr. med. Stephanie Bendrich

Dr. med. Stephanie Bendrich

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

11/3/25

Identifier Type: -

Identifier Source: org_study_id