Decision Making, SharedNCT04940936
Shared Decision Making on Radiation Dose for Lung Malignancies
A study testing A Patient Decision Aid in people with Decision Making, Shared and Stereotactic Body Radiation Therapy, run by Vejle Hospital at 1 site in Denmark.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Decision Making, Shared, Stereotactic Body Radiation Therapy, Lung Cancer, Non-small Cell
- What is being tested?
- A Patient Decision Aid
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- 12 Nov 2021to 31 Mar 2031
- Phase
- Interventional
- 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
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Vejle Hospital, Department of Oncology
Vejle, Region Syddanmark, 7100
About this study
Official title: Shared Decision Making on Radiation Dose for Stereotactic Body Radiotherapy of Malignancies Located Less Than 1 cm From the Thoracic Wall. A Randomized Trial
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.
Read the detailed description
When a lung tumor is located close to the thoracic wall, there is an increased risk of developing chest wall pain or rib fracture following SBRT of the tumor. A meta-analysis has shown the pooled risk of chest wall pain to be 11% and that of rib fracture to be 6.3% with significant differences between individual studies. These side effects may occur several years after the treatment.
SDM is a collaborative process allowing patients and healthcare professionals to make decisions together taking into account the best scientific evidence as well as patients' values, preferences, life situation, and knowledge about disease process and prognosis.
PtDAs are tools designed to assist caregivers in the process of informing patients about relevant treatment options. PtDAs contain factual and balanced information about the options and the pertaining pros, cons, and probabilities. The tools are relevant when the decision is preference-sensitive, that is, the right treatment cannot be decided based on professional knowledge alone. The use of PtDAs has shown to provide a number of positive effects on the patients, including increased knowledge of options, better understanding of risks, and clarity as to what matters most in their life situation. Other effects are decreased decisional conflict and a higher degree of involvement in decision making.
This is a randomized trial enrolling eligible patients during a period of 16 months. SDM will be used in the planning of SBRT to patients with peripheral non-small cell lung tumors or lung metastases and offer them the choice between high (66 Gy in 3 fractions) and low (45 Gy in 3 fractions) radiation dose.
A total of 40 patients will be included in the study, i.e. 20 patients in each arm.
- Conditions
- Decision Making, Shared, Stereotactic Body Radiation Therapy, Lung Cancer, Non-small Cell, Radiation Toxicity, Lung Metastases
- Being tested
- A Patient Decision Aid
- Keywords
- Stereotactic body radiation therapy, Lung malignancy, Shared decision making, Patient Decision Aid
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Radiation Injuries, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A Patient Decision AidBehavioural
The Patient Decision Aid informs about the pros and cons of each option
| Study group | Role | What they receive |
|---|---|---|
| A - control | No intervention | The patients are offered high or lower dose according to usual practice |
| B - Intervention | Experimental | The Patient Decision Aid is used during the consultation to aid in the decision on high or lower dose. Receives: Behavioral: A Patient Decision Aid |
What is being measured
The primary outcome is the main question the study is designed to answer.
The extent of shared decision making in the consultation between patient and oncologist as measured by the OPTION tool
Minimum value: 0. Maximum value: 48. The higher the value, the higher the extent of SDM during the consultation
Measured: During the one hour primary consultation.
Secondary outcomes (9)
Difference in patient perceived level of shared decision making between arm A and B as measured by the tool SDM-Q9.
Minimum value 0. Maximum value 45. The higher the value, the higher the patient experienced extent of SDM during the consultation
Measured: Immediately after the primary consultation
Difference in patient perceived level of shared decision making between arm A and B as measured by the tool SDM_P4
Minimum value 0. Maximum value 4. The higher the value, the higher the patient experienced extent of SDM during the consultation
Measured: Immediately after the primary consultation
Difference in patient perceived level of shared decision making between arm A and B as measured by the tool CollaboRATE
Minimum value 0. Maximum value 27. The higher the value, the higher the patient experienced extent of SDM during the consultation
Measured: Immediately after the primary consultation
Difference in decisional conflict between patients in arm A and B as measured by the Decision Conflict Scale
Minimum value: 0. Maximum value: 64. The higher the value, the more decisional conflict.
Measured: Immediately after the primary consultation
Difference in decisional regret between patients in arm A and B as measured by the Decision Regret Scale
Minimum value: 5. Maximum value: 25. The higher the value, the more decisional regret.
Measured: Reported by the patients six months and 3 years after the primary consultation
Difference in fear of cancer recurrence between patients in arm A and B as measured by the Fear of Cancer Recurrence - Short Form questionnaire
Minimum value: 0. Maximum value: 36. The higher the value, the more fear of recurrence.
Measured: Reported by the patients six months and 3 years after the primary consultation
Number of patients developing chest wall pain and/or rib fracture during the 5-year follow-up program
Evaluated by the physician every three months the first two years and then every six months the following three years.
Measured: Up to 5 years
Quality of Life as measured by the questionnaire EORTC QLQ-C30.
Thirty questions with two different scales (1-4 and 1-7). The higher the value, the more symptoms/problems.
Completed by the patients every three months the first two years and then every six months the following three years.
Measured: Up to 5 years
Quality of Life as measured by the questionnaire EORTC QLQ-LC29
Twenty-nine questions on a scale from 1 to 4. The higher the value, the more symptoms/problems.
Completed by the patients every three months the first two years and then every six months the following three years.
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2021
- Study start12 Nov 2021
- Primary completion30 Jan 2026
- Study completion31 Mar 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Decision Making, SharedStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- After inclusion in the study, the patients are randomized into Arm A and B as follows: Arm A: Consultation as usual. Patients are informed about treatment and the two dose options according to current standards and routines. Arm B: Consultation using the PtDA. Patients are informed about treatment and dose options using the PtDA to make the pros and cons clearer to the patients. The doctors and nurses in the Radiotherapy Department will be educated in the use of the PtDA before initiation of the study.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vejle Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas L Fink, MD, Principal investigator, Department of Oncology, Vejle Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04940936
- Sponsor's protocol ID
- SDM Lung SBRT
- Status last verified
- May 2026
- First submitted
- 11 Jun 2021
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Anonymized data will be available on relevant request.
Publications
Fink 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.
PubMed 39833001
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shared Decision Making on Radiation Dose for Stereotactic Body Radiotherapy of Malignancies Located Less Than 1 cm From the Thoracic Wall. A Randomized Trial
- ClinicalTrials.gov ID
- NCT04940936
- Acronym / sponsor ID
- SDM Lung SBRT
- Conditions
- Decision Making, Shared, Stereotactic Body Radiation Therapy, Lung Cancer, Non-small Cell, Radiation Toxicity, Lung Metastases
- Keywords
- Stereotactic body radiation therapy, Lung malignancy, Shared decision making, Patient Decision Aid
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Vejle HospitalUniversity, hospital or other
- Study start
- 12 Nov 2021 (actual)
- Primary completion
- 30 Jan 2026 (actual)
- Study completion
- 31 Mar 2031 (estimated)
- First posted
- 28 Jun 2021 (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.
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.
Detailed description
When a lung tumor is located close to the thoracic wall, there is an increased risk of developing chest wall pain or rib fracture following SBRT of the tumor. A meta-analysis has shown the pooled risk of chest wall pain to be 11% and that of rib fracture to be 6.3% with significant differences between individual studies. These side effects may occur several years after the treatment.
SDM is a collaborative process allowing patients and healthcare professionals to make decisions together taking into account the best scientific evidence as well as patients' values, preferences, life situation, and knowledge about disease process and prognosis.
PtDAs are tools designed to assist caregivers in the process of informing patients about relevant treatment options. PtDAs contain factual and balanced information about the options and the pertaining pros, cons, and probabilities. The tools are relevant when the decision is preference-sensitive, that is, the right treatment cannot be decided based on professional knowledge alone. The use of PtDAs has shown to provide a number of positive effects on the patients, including increased knowledge of options, better understanding of risks, and clarity as to what matters most in their life situation. Other effects are decreased decisional conflict and a higher degree of involvement in decision making.
This is a randomized trial enrolling eligible patients during a period of 16 months. SDM will be used in the planning of SBRT to patients with peripheral non-small cell lung tumors or lung metastases and offer them the choice between high (66 Gy in 3 fractions) and low (45 Gy in 3 fractions) radiation dose.
A total of 40 patients will be included in the study, i.e. 20 patients in each arm.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- After inclusion in the study, the patients are randomized into Arm A and B as follows: Arm A: Consultation as usual. Patients are informed about treatment and the two dose options according to current standards and routines. Arm B: Consultation using the PtDA. Patients are informed about treatment and dose options using the PtDA to make the pros and cons clearer to the patients. The doctors and nurses in the Radiotherapy Department will be educated in the use of the PtDA before initiation of the study.
| Arm | Type | Receives |
|---|---|---|
| A - control | No intervention | –The patients are offered high or lower dose according to usual practice |
| B - Intervention | Experimental | Behavioral: A Patient Decision AidThe Patient Decision Aid is used during the consultation to aid in the decision on high or lower dose. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A Patient Decision AidThe Patient Decision Aid informs about the pros and cons of each option | Behavioural | B - Intervention |
Primary outcome
The extent of shared decision making in the consultation between patient and oncologist as measured by the OPTION tool
Time frame: During the one hour primary consultation.
Minimum value: 0. Maximum value: 48. The higher the value, the higher the extent of SDM during the consultation
9 secondary outcomes
Difference in patient perceived level of shared decision making between arm A and B as measured by the tool SDM-Q9.
Time frame: Immediately after the primary consultation
Difference in patient perceived level of shared decision making between arm A and B as measured by the tool SDM_P4
Time frame: Immediately after the primary consultation
Difference in patient perceived level of shared decision making between arm A and B as measured by the tool CollaboRATE
Time frame: Immediately after the primary consultation
Difference in decisional conflict between patients in arm A and B as measured by the Decision Conflict Scale
Time frame: Immediately after the primary consultation
Difference in decisional regret between patients in arm A and B as measured by the Decision Regret Scale
Time frame: Reported by the patients six months and 3 years after the primary consultation
Difference in fear of cancer recurrence between patients in arm A and B as measured by the Fear of Cancer Recurrence - Short Form questionnaire
Time frame: Reported by the patients six months and 3 years after the primary consultation
Number of patients developing chest wall pain and/or rib fracture during the 5-year follow-up program
Time frame: Up to 5 years
Quality of Life as measured by the questionnaire EORTC QLQ-C30.
Time frame: Up to 5 years
Quality of Life as measured by the questionnaire EORTC QLQ-LC29
Time frame: Up to 5 years
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 11 May 2026.
- Derived from this study: PubMed 39833001Fink 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.
- Individual participant dataSharing planned: No. Anonymized data will be available on relevant request.
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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. This study is not recruiting at the moment.
Thomas L Fink, MD principal investigator
Department of Oncology, Vejle Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A Patient Decision Aid in people with Decision Making, Shared and Stereotactic Body Radiation Therapy, run by Vejle Hospital at 1 site in Denmark.
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 7 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The extent of shared decision making in the consultation between patient and oncologist as measured by the OPTION tool (time frame: During the one hour primary consultation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04940936, which also lists 1 linked publication.
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 11 May 2026; AzTrials last refreshed its copy on 27 Oct 2026.