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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
40
The Patient Decision Aid informs about the pros and cons of each option
Vejle Hospital, Department of Oncology
Vejle, Region Syddanmark, Denmark
RECRUITINGThe 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
Time frame: During the one hour primary consultation.
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
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
Minimum value 0. Maximum value 4. The higher the value, the higher the patient experienced extent of SDM during the consultation
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
Minimum value 0. Maximum value 27. The higher the value, the higher the patient experienced extent of SDM during the consultation
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
Minimum value: 0. Maximum value: 64. The higher the value, the more decisional conflict.
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
Minimum value: 5. Maximum value: 25. The higher the value, the more decisional regret.
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
Minimum value: 0. Maximum value: 36. The higher the value, the more fear of recurrence.
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
Evaluated by the physician every three months the first two years and then every six months the following three years.
Time frame: 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.
Time frame: 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.
Time frame: Up to 5 years
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