NCT05615909Completed
PRO-MR-RT Systematic Patient-reported Outcomes to Pelvic Online MRgRT
PRO-MR-RT Systematic Web-based Patient-reported Outcomes for a Personalized, Patient-centered Symptom Management and Clinical Assessment of Pelvic Toxicity to Magnetic Resonance Radiation Therapy
Source: ClinicalTrials.gov · Last updated 19 Aug 2024
Brief summary (registry, in English)
In 2018 the Unity MR-linac was approved for treating patients with online magnetic resonance (MR)-guided radiotherapy. With the MR-linac it is possible to get real-time MR images with high soft tissue contrast, adapt the radiotherapy plan and subsequently irradiate at each treatment fraction. Patients with prostate cancer is one of the patient groups referred for this new treatment and potentially they will benefit with decreased margins around the tumour and increased local tumor control rates. The acute toxicity is important when evaluating treatment tolerability. A prospective longitudinal observation of the acute treatment toxicity to online MR-guided radiotherapy is therefore essential in the evaluation of this new technology. Patient-reported outcomes (PRO) are disease symptoms and treatment toxicity reported directly by patients themselves without clinician interpretation. Several studies have indicated that clinicians tend to underreport the incidence and severity of patient symptoms, thus a systematic use of PROs in clinical trials can provide valuable evidence to the clinicians. As online MR-guided radiotherapy (MRgRT) is a new technology there is limited research worldwide on patient-reported symptoms and quality of life. The objective of this study is therefore to prospectively investigate the patient-reported acute toxicity and changes in quality of life during and after online MR-guided radiotherapy.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 156 (actual)
- First submitted
- 1 Nov 2022
- Start date
- 19 Nov 2020
- Primary completion date
- 30 Jun 2023
- Lead sponsor
- Odense University Hospital
- Diseases
- Prostate cancer
- NCT number
- NCT05615909
What you commit to
- Study type: Observational
- Participants enrolled: 156
- From 19 Nov 2020 to the primary completion date, 30 Jun 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Cognitively unable to provide informed consent
- Unable ro read, understand and complete patient-reported surveys in Danish (electronic or paper-based)
Who the study is looking for
- patients diagnosed with cancer in the prostate
- referred for primary radiotherapy or salvage radiotherapy
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Odense University Hospital Coordinator of this site? Confirm its status | Odense | Denmark | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.