Shared decision-making for radiation dose in lung cancer treatment
Shared Decision Making on Radiation Dose for Stereotactic Body Radiotherapy of Malignancies Located Less Than 1 cm From the Thoracic Wall. A Randomized Trial
This study is testing a new tool to help lung cancer patients and their doctors work together to choose the best radiation dose for treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Vejle Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Vejle, Region Of Southern Denmark) |
| Trial ID | NCT04940936 on ClinicalTrials.gov |
What this trial studies
This study develops a Patient Decision Aid (PtDA) in collaboration with patients to enhance shared decision-making (SDM) between patients and physicians regarding the radiation dose for stereotactic body radiation therapy (SBRT) in lung tumors near the thoracic wall. The PtDA provides balanced information about treatment options, risks, and benefits, aiming to empower patients in their treatment planning. The trial will enroll eligible patients over a 16-month period and assess the impact of the PtDA on patient involvement and decision-making clarity.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with non-small cell lung cancer or metastases located within 1 cm of the thoracic wall, who are eligible for SBRT.
Not a fit: Patients with previous radiation therapy in the thoracic region or those with mental or social conditions that hinder decision-making may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved patient engagement and satisfaction in treatment decisions for lung cancer.
How similar studies have performed: Previous studies utilizing Patient Decision Aids have shown positive outcomes in enhancing patient knowledge and involvement in treatment decisions.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Vejle, Region Of Southern Denmark
- Vejle Hospital, Department of Oncology — Vejle, Region Of Southern Denmark, Denmark (Recruiting)
Study contacts
- Principal investigator: Thomas L Fink, MD — Department of Oncology, Vejle Hospital
- Study coordinator: Thomas L Fink, MD
- Email: thomas.leth.fink@rsyd.dk
- Phone: +4579405446
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.