Clinical trial · Interventional
Shared Decision Making on Radiation Dose for Lung Malignancies
Shared Decision Making on Radiation Dose for Stereotactic Body Radiotherapy of Malignancies Located Less Than 1 cm From the Thoracic Wall. A Randomized Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A Patient Decision Aid (PtDA) is developed during a workshop in close collaboration with selected patients. The PtDA is subsequently used in the consultation between patient and physician to facilitate their shared decision on the dose of stereotactic body radiation therapy (SBRT) for lung tumors located less than 1 cm from the thoracic wall. Hypothesis: The use of a PtDA will increase the extent of Shared Decision Making (SDM) during the consultation and result in patients being more directly involved in the planning of their treatment.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Decision Making, Shared | — | UNRESOLVED | — |
| Lung Cancer, Non-small Cell | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Lung Metastases | — | UNRESOLVED | — |
| Radiation Toxicity | — | UNRESOLVED | — |
| Stereotactic Body Radiation Therapy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| A Patient Decision Aid | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- A - control
- description
- The patients are offered high or lower dose according to usual practice
- type
- EXPERIMENTAL
- label
- B - Intervention
- description
- The Patient Decision Aid is used during the consultation to aid in the decision on high or lower dose.
- interventionNames
- Behavioral: A Patient Decision Aid
Primary outcomes (1)
- measure
- The extent of shared decision making in the consultation between patient and oncologist as measured by the OPTION tool
- timeFrame
- During the one hour primary consultation.
- description
- Minimum value: 0. Maximum value: 48. The higher the value, the higher the extent of SDM during the consultation
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 18 years * Histologically confirmed or high probability of non-small cell lung cancer, or metastasis from other cancer, located ≤ 1 cm from the thoracic wall. High probability refers to consensus on the diagnosis at the local multi-disciplinary lung tumor conference. * Eligible for stereotactic body radiation therapy in ablative doses (i.e. 66/45 Gy in 3 fractions) following national guidelines (2). * Can read and understand Danish. * Written and orally informed consent. * Performance status 0-2 * Life expectancy \> 6 months assessed by the physician during the consultation. Exclusion Criteria: * Previous radiation therapy in the thoracic region (lung, breast or mediastinum), if it is not possible to produce a new radiation plan of 66 or 45 Gy in 3 fractions that considers previous radiation therapy and still complies with all constraints, including dose to the thoracic wall. Previous surgery in the thorax is allowed. * Mental or social conditions preventing full understanding of the information or the planned treatment and follow-up.
References
Publications (1)
- DERIVEDFink TL, Hansen TF, Kristiansen C, Hansen TS, Thing RS, Timm S, Steffensen KD. Enhancing patient engagement: the influence of an in-consult patient decision aid on shared decision-making for lung tumour radiation - protocol for the randomised trial 'SDM Lung SBRT'. BMJ Open. 2025 Jan 20;15(1):e088595. doi: 10.1136/bmjopen-2024-088595. PMID 39833001