Shared Decision Making on Radiation Dose for Lung Malignancies

Radiation Toxicity Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04940936
• Other study ID #: SDM Lung SBRT
• Status: Recruiting
• Phase: N/A
• Start date: November 12, 2021
• Est. completion date: August 31, 2030

Study information

• Verified date: October 2023
• Source: Vejle Hospital
• Contact: Thomas L Fink, MD
• Phone: +4579405446
• Email: thomas.leth.fink[@]rsyd.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: August 31, 2030
• Est. primary completion date: August 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Decision Making, Shared
• Lung Cancer, Non-small Cell
• Lung Metastases
• Neoplasms
• Radiation Toxicity
• Stereotactic Body Radiation Therapy

Intervention

Behavioral:
• A Patient Decision Aid
The Patient Decision Aid informs about the pros and cons of each option

Locations

Country	Name	City	State
Denmark	Vejle Hospital, Department of Oncology	Vejle	Region Of Southern Denmark

Sponsors (1)

Lead Sponsor	Collaborator
Vejle Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	Immediately after the primary consultation
Secondary	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	Immediately after the primary consultation
Secondary	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	Immediately after the primary consultation
Secondary	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.	Immediately after the primary consultation
Secondary	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.	Reported by the patients six months and 3 years after the primary consultation
Secondary	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.	Reported by the patients six months and 3 years after the primary consultation
Secondary	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.	Up to 5 years
Secondary	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.	Up to 5 years
Secondary	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.	Up to 5 years