Quality of Life (QOL)DoItAgainNCT06921863
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.
An observational study of Quality of Life (QOL) and Decision Making ,Shared, run by University Medical Center Goettingen.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Quality of Life (QOL), Decision Making ,Shared
- How many people
- 165 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2025to 1 Oct 2032
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- Indication for radiotherapy
- Patient information and declaration of consent
- Patients age ≥ 18 years
Who cannot join
- 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
About this study
Official title: Decisional Regret Following Radiotherapy Against Cancer With Poor to Excellent Prognosis
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
Read the 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
- Keywords
- Decisional Regret, Radiotherapy, Quality of Life
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: from enrollment to the end of routinely performed clinical follow-up examinations after 5 yeasr after RT start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2025
- Study start1 Jul 2025 (estimated)
- Primary completion1 Oct 2029 (estimated)
- Study completion1 Oct 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of Life (QOL)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 165 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- University Medical Center Goettingen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. med. Stephanie Bendrich, University Medical Center Goettingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06921863
- Sponsor's protocol ID
- 11/3/25
- Acronym
- DoItAgain
- Status last verified
- Apr 2025
- First submitted
- 11 Mar 2025
- Last updated
- 10 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decisional Regret Following Radiotherapy Against Cancer With Poor to Excellent Prognosis
- ClinicalTrials.gov ID
- NCT06921863
- Acronym / sponsor ID
- DoItAgain / 11/3/25
- Conditions
- Quality of Life (QOL), Decision Making ,Shared
- Keywords
- Decisional Regret, Radiotherapy, Quality of Life
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 165 participants (estimated)
- Lead sponsor
- University Medical Center GoettingenUniversity, hospital or other
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 1 Oct 2029 (estimated)
- Study completion
- 1 Oct 2032 (estimated)
- First posted
- 10 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- Indication for radiotherapy
- Patient information and declaration of consent
- Patients age ≥ 18 years
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Decisional Regret
Time frame: from enrollment to the end of routinely performed clinical follow-up examinations after 5 yeasr after RT start
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).
Quality of Life after Radiotherapy
Time frame: from enrollment to the end of routinely performed clinical follow-up examinations after 5 yeasr after RT start
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Quality of Life (QOL)
Active, not recruiting
Smartphone-Guided Paced Breathing and Aerobic Exercise for Essential Hypertension
Essential (Primary) Hypertension
Not yet recruiting
Combined Versus Multicomponent Training in People With Chronic Kidney Disease Stages 3a and 3b
Chronic Kidney Disease Stage 3A, Chronic Kidney Disease Stage 3B
Not yet recruiting
Development and Testing of Nutritional Algorithms (NACHO)
Nutrition Poor, Nutritional Deficiency
Active, not recruitingPhase 3
ExclUsive endocRine Therapy Or Radiation theraPy for Women Aged ≥70 Years Early Stage Breast Cancer
Breast Cancer
Not yet recruitingObservational study
Determinants of Radiation Dermatitis in Head and Neck Cancer Patients Receiving Preventive Photobiomodulation
Head and Neck Neoplasms, Radiodermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Quality of Life (QOL) and Decision Making ,Shared, run by University Medical Center Goettingen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decisional Regret (time frame: from enrollment to the end of routinely performed clinical follow-up examinations after 5 yeasr after RT start). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2025.