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

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.

Study Overview

• Status: Recruiting
• Conditions: Lung Cancer, Non-small Cell; Lung Metastases; Radiation Toxicity; Stereotactic Body Radiation Therapy; Decision Making, Shared
• Intervention / Treatment: Behavioral: A Patient Decision Aid

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Thomas L Fink, MD; Phone Number: +4579405446; Email: thomas.leth.fink@rsyd.dk

Study Locations

• Denmark
  • Region Of Southern Denmark
    • Vejle, Region Of Southern Denmark, Denmark, 7100
      • Recruiting
      • Vejle Hospital, Department of Oncology
      • Contact: Thomas L Fink, MD; Phone Number: +4579405446; Email: thomas.leth.fink@rsyd.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: A - control; The patients are offered high or lower dose according to usual practice
Experimental: B - Intervention; The Patient Decision Aid is used during the consultation to aid in the decision on high or lower dose.	Behavioral: A Patient Decision Aid; The Patient Decision Aid informs about the pros and cons of each option

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Vejle Hospital
• Investigators: Principal Investigator: Thomas L Fink, MD, Department of Oncology, Vejle Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 12, 2021
• Primary Completion (Estimated): August 31, 2025
• Study Completion (Estimated): August 31, 2030

Study Registration Dates

• First Submitted: June 11, 2021
• First Submitted That Met QC Criteria: June 17, 2021
• First Posted (Actual): June 28, 2021

Study Record Updates

• Last Update Posted (Actual): October 31, 2023
• Last Update Submitted That Met QC Criteria: October 30, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Shared decision making; Stereotactic body radiation therapy; Patient Decision Aid; Lung malignancy
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: SDM Lung SBRT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Anonymized data will be available on relevant request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No