Clinical trial NCT04940936: Shared Decision Making on Radiation Dose for Lung Malignancies
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Decision Making, Shared
Stereotactic Body Radiation Therapy
Lung Cancer, Non-small Cell
Radiation Toxicity
Lung Metastases
Keywords: Stereotactic body radiation therapy
Lung malignancy
Shared decision making
Patient Decision Aid
Lead sponsor: Vejle Hospital
Sponsor class: OTHER
First posted: 2021-06-28
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: OTHER

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.

Detailed 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.

Eligibility 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.

Primary outcomes:
measure: The extent of shared decision making in the consultation between patient and oncologist as measured by the OPTION tool
timeFrame: During the one hour primary consultation.
Secondary outcomes:
measure: Difference in patient perceived level of shared decision making between arm A and B as measured by the tool SDM-Q9.
timeFrame: Immediately after the primary consultation
measure: Difference in patient perceived level of shared decision making between arm A and B as measured by the tool SDM_P4
timeFrame: Immediately after the primary consultation
measure: Difference in patient perceived level of shared decision making between arm A and B as measured by the tool CollaboRATE
timeFrame: Immediately after the primary consultation
measure: Difference in decisional conflict between patients in arm A and B as measured by the Decision Conflict Scale
timeFrame: Immediately after the primary consultation
measure: Difference in decisional regret between patients in arm A and B as measured by the Decision Regret Scale
timeFrame: Reported by the patients six months and 3 years after the primary consultation
measure: Difference in fear of cancer recurrence between patients in arm A and B as measured by the Fear of Cancer Recurrence - Short Form questionnaire
timeFrame: Reported by the patients six months and 3 years after the primary consultation
measure: Number of patients developing chest wall pain and/or rib fracture during the 5-year follow-up program
timeFrame: Up to 5 years
measure: Quality of Life as measured by the questionnaire EORTC QLQ-C30.
timeFrame: Up to 5 years
measure: Quality of Life as measured by the questionnaire EORTC QLQ-LC29
timeFrame: Up to 5 years
Other outcomes:
Locations:
city: Vejle
country: Denmark
facility: Vejle Hospital, Department of Oncology
state: Region Of Southern Denmark
Study officials:
affiliation: Department of Oncology, Vejle Hospital
name: Thomas L Fink, MD
role: PRINCIPAL_INVESTIGATOR
References: