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NCT Number: NCT04940936

Shared Decision Making on Radiation Dose for Lung Malignancies

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Decision Making, Shared Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Cancer, Non-small Cell Lung Diseases Lung Metastases Lung Neoplasms Neoplasms Neoplasms by Site Radiation Injuries Radiation Toxicity Respiratory Tract Diseases Respiratory Tract Neoplasms Stereotactic Body Radiation Therapy Thoracic Neoplasms Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vejle Hospital, Department of Oncology

Vejle, Region Syddanmark, 7100, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

A Patient Decision Aid

Behavioral

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

Primary outcomes

  1. The extent of shared decision making in the consultation between patient and oncologist as measured by the OPTION tool

    Time frame: During the one hour primary consultation.

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

Secondary outcomes

  1. Difference in patient perceived level of shared decision making between arm A and B as measured by the tool SDM-Q9.

    Time frame: Immediately after the primary consultation

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

  2. Difference in patient perceived level of shared decision making between arm A and B as measured by the tool SDM_P4

    Time frame: Immediately after the primary consultation

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

  3. Difference in patient perceived level of shared decision making between arm A and B as measured by the tool CollaboRATE

    Time frame: Immediately after the primary consultation

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

  4. Difference in decisional conflict between patients in arm A and B as measured by the Decision Conflict Scale

    Time frame: Immediately after the primary consultation

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

  5. Difference in decisional regret between patients in arm A and B as measured by the Decision Regret Scale

    Time frame: Reported by the patients six months and 3 years after the primary consultation

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

  6. Difference in fear of cancer recurrence between patients in arm A and B as measured by the Fear of Cancer Recurrence - Short Form questionnaire

    Time frame: Reported by the patients six months and 3 years after the primary consultation

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

  7. Number of patients developing chest wall pain and/or rib fracture during the 5-year follow-up program

    Time frame: Up to 5 years

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

  8. Quality of Life as measured by the questionnaire EORTC QLQ-C30.

    Time frame: Up to 5 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.

  9. Quality of Life as measured by the questionnaire EORTC QLQ-LC29

    Time frame: Up to 5 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.

Sponsors and collaborators

Lead sponsor

Vejle Hospital

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2026
Study completion
2031
First posted
Jun 28, 2021
Registry last updated
May 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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