Neoplasms

Symptoms and General Pathology

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Neoplasm Metastasis

Lung Neoplasms

Carcinoma

Carcinoma, Non-Small-Cell Lung

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

The patients are offered high or lower dose according to usual practice

The Patient Decision Aid is used during the consultation to aid in the decision on high or lower dose.

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

A Patient Decision Aid

Thomas L Fink, MD

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.

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.

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.

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

Anonymized data will be available on relevant request.

Minimum value: 0. Maximum value: 48. The higher the value, the higher the extent of SDM during the consultation

Minimum value 0. Maximum value 45. The higher the value, the higher the patient experienced extent of SDM during the consultation

Minimum value 0. Maximum value 4. The higher the value, the higher the patient experienced extent of SDM during the consultation

Minimum value 0. Maximum value 27. The higher the value, the higher the patient experienced extent of SDM during the consultation

Minimum value: 0. Maximum value: 64. The higher the value, the more decisional conflict.

Minimum value: 5. Maximum value: 25. The higher the value, the more decisional regret.

Minimum value: 0. Maximum value: 36. The higher the value, the more fear of recurrence.

Evaluated by the physician every three months the first two years and then every six months the following three years.

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.

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Shared Decision Making on Radiation Dose for Lung Malignancies	NCT04940936	Decision Making... Stereotactic Bo... Lung Cancer, No... Radiation Toxic... Lung Metastases	A Patient Decis...	18 Years -	Vejle Hospital
Shared Decision Making on Radiation Dose for Lung Malignancies	NCT04940936	Decision Making... Stereotactic Bo... Lung Cancer, No... Radiation Toxic... Lung Metastases	A Patient Decis...	18 Years -	Vejle Hospital

Spots Global Cancer Trial Database for a patient decision aid