Shared Decision Making on Radiation Dose for Lung Malignancies

NCT04940936 | Recruiting

• 1 other identifier: SDM Lung SBRT
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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 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

Decision Making, Shared; Lung Cancer, Non-small Cell; Radiation Toxicity; Lung Metastases; Stereotactic Body Radiation Therapy

Keywords

Stereotactic body radiation therapy; Lung malignancy; Shared decision making; Patient Decision Aid

Outcome Measures

Primary Outcomes (1)

• 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

  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.

  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

  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

  Immediately after the primary consultation

• Difference in decisional conflict between patients in arm A and B as measured by the Decision Conflict Scale

  Immediately after the primary consultation

• Difference in decisional regret between patients in arm A and B as measured by the Decision Regret Scale

  Reported by the patients six months and 3 years after the primary consultation

Study Arms (2)

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.

Behavioral: A Patient Decision Aid

Interventions

A Patient Decision Aid BEHAVIORAL

The Patient Decision Aid informs about the pros and cons of each option

B - Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vejle Hospital: lead

Study Sites (1)

Vejle Hospital, Department of Oncology

Vejle, Region Syddanmark, 7100, Denmark

RECRUITING

Related Publications (1)

• 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.

  PMID: 39833001 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Radiation Injuries; Lung Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Wounds and Injuries

Study Officials

• Thomas L Fink, MD

  Department of Oncology, Vejle Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas L Fink, MD

CONTACT

+4579405446; thomas.leth.fink@rsyd.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 11, 2021
• First Posted: June 28, 2021
• Study Start: November 12, 2021
• Primary Completion: March 31, 2026
• Study Completion (Estimated): March 31, 2031
• Last Updated: December 8, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)