Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

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Symptoms and General Pathology

Carcinoma, Non-Small-Cell Lung

Neoplasm Metastasis

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

All Drugs and Chemicals

Immunomodulating Agents

Chemotherapy Chemoradiotherapy Radiotherapy Immunotherapy Or a combination of above

SABR combined immunotherapy

Radiotherapy combined immunotherapy

Decision tool

Iva Halilaj, Msc

Relinde Lieverse, MD

Philippe Lambin, Prof. MD

This is a trial-specific (NCT03705403) decision aid (tPDA) for stage IV NSCLC patients that might want to participate.

We want to investigate if a tPDA would be (significantly) helpful for these patients in making a decision.

ImmunoSABR has a complex study design, we expect that the patients get a better overview of the trial via the tPDA because you can bring multiple tools together. (text, video, questions, pictures, timelines, etc.)

A lung cancer patient might want to take part in the ImmunoSABR phase 2 trial (NCT03705403). Before they can decide, it is important that the patients understand why the research is being done and what it would involve for them.

This tPDA will give information about this trial via text, small movies, quiz and preferences. In the end, the patient will receive an overview of their choices.

Detailed Description ImmunoSABR:

IMMUNOSABR will include 126 patients. In this single-stage controlled randomised open-label phase II trial, we aim to demonstrate an absolute increase in progression-free survival (primary endpoint). PFS will be determined as the time between randomisation and disease progression, according to RECIST 1.1, death due to any cause or last patient contact alive and progression-free. Patients will be randomized between control (no immunocytokine) and experimental arms (with immunocytokine L19-IL2) in a 1:1 ratio. The accrual period will be 29 months (or 2.41 years), and the minimum follow-up will be 18 months (or 1.5 years), making the total study duration 47 months. Comparison between control and experimental arms will be made using the Log-Rank statistic. This test for superiority will be one-sided with the desired type I error of 0.10 and power of 0.90.

Patients enrolled in the trial will be randomised into the control arm (C-arm) or experimental arm (E-arm).

C-arm: Standard of Care (SOC) according to the local and national guidelines: (wait and see or surgery and/or chemotherapy and/or standard (symptomatic) radiotherapy and/or SABR, oligometastatic disease.

E-arm: SABR (oligometastatic disease) or radiotherapy (diffuse disease) + L19-IL2 up to 6 cycles (+ aPD(L)1 if SOC) The expected 1.5-year PFS is 15% in the C-arm and 35% in the E-arm. A sample size of 116 patients (58 patients per treatment arm) is needed to show this difference of 20% in PFS, using a logrank test with a two-sided alpha of 0.05 and power of 85%. Patients will be evenly divided over the two arms. Assuming a drop-out rate of 10%, a total of 126 patients (63 per arm) need to be included.

Primary objective The main objective of the trial is to test if the activity of the combination of (SAB)R and L19-IL2 in patients with metastatic NSCLC will result in improved progression-free survival (PFS) compared to the SOC.

Secondary Objectives

Assessment of the PFS of the patient cohort, at 5 years after randomisation. Assessment of the overall survival of the patient cohort, at 5 years after randomisation.

To assess the toxicity of this treatment schedule; To assess Quality of Life (QoL); To assess the occurrence of an Out of Field Radio-Immune (OFRI) response / abscopal effect using imaging; To assess the occurrence of an In Field Radio-Immune (IFRI) response using imaging; To perform correlative biomarker studies related to treatment response.

Exploratory endpoints:

Correlative biomarker studies:

Tumour tissue: e.g EDB expression, non-synonymous mutations, immune monitoring; Blood: e.g. EDB expression, cfDNA, and immune monitoring; Radiomics on CT and if available MRI; Faeces: diversity in microbiota. iRECIST Tumour grow kinetics

Trial-specific Patient Decision Aid (tPDA) of the ImmunoSABR Phase 2

Patients' decisional needs (development phase):semi-structured interviews with patients about the decision about their treatment, and what information the patients need to make.

Quantitative research using a questionnaire based on the International Standard ISO-9242-11. This questionnaire measure to what extent the decision aid is easy to use. Answers will be clear for the patient; agree, neutral, disagree.

Decisional conflict will be assessed using the DCS (Decisional conflict scale): change in DCS between baseline group (usual care) and ImmunoSABR clinical trial. Answers will be clear for the patient; agree,neutral, disagree. Items are scored and summed. High total score will be in favour of the tPDA

Patient's preference to participate in medical decisions will be assessed using the 3-item Control Preference Scale (CPS):change in CPS between baseline group (usual care) and ImmunoSABR clinical trial . Questions and answers will be clear for the patient; agree, neutral, disagree. Items are scored and summed. High total score will be in favour of the tPDA

Patient's perception of the shared decision-making process will be assessed using the (shared decision making) SDM-Q9 instrument for patients: change in SDM between baseline group (usual care) and ImmunoSABR clinical trial. 9 questions with clear answers; totally disagree, strongly disagree, disagree, agree, strongly agree, totally agree.

Doctor's perception of the shared decision-making process will be assessed using the SDM-Q9 instrument for professionals: change in SDM between baseline group (usual care) and ImmunoSABR clinical trial. 9 questions with clear answers; totally disagree, strongly disagree, disagree, agree, strongly agree, totally agree.

Patients satisfaction with the tPDA will be tested via questions with predefined answers; agree,neutral, disagree. Items are scored and summed. High total score will be in favour of the tPDA

Patients recommendation regarding the tPDA will be tested via questions with predefined answers; agree, neutral, disagree. Items are scored and summed. High total score will be in favour of the tPDA

Maastricht University

Skin and Connective Tissue Diseases

Breast Neoplasms

Investigators recruited patients scheduled for a plastic/reconstruction consult. Investigators identified patients who completed a mastectomy, or were scheduled for one, and considering reconstruction, but didn't have an appointment with a plastic/reconstructive surgeon. A study team member called the patient to determine their interest and offered for them to come to their scheduled appointment 30 minutes early to meet a coordinator or offered them the option to complete pre-appointment procedures at home. Patients randomized using computer random assignment. If the patient didn't have an appointment, she scheduled a convenient time to complete study procedures with research staff. Patients interacted with the decision tool. They were asked to answer a survey. After the appointment, the team collected information consult duration, decision process quality, and measures of shared decision making. Patient participation was approximately 30 minutes.

Investigators recruited patients scheduled for plastic/reconstruction consultation. Investigators identified patients who completed or scheduled a mastectomy, and considering reconstruction, but didn't have an appointment with a plastic/reconstructive surgeon. A study team member called the patient to determine their interest and offered for them to come to their scheduled appointment 30 minutes early to meet a coordinator or to complete the pre-appointment procedures at home. Patients were randomized using computer random assignment. If the patient didn't have an appointment, she scheduled a convenient time to complete study procedures with research staff. Patients interacted with American Society of Plastic Surgeons booklet "Breast Reconstruction." They were asked to answer a survey. After the appointment, the team collected information about consult duration, decision process quality, and measures of shared decision making. Patient participation was approximately 30 minutes.

-Booklet from the American Society of Plastic Surgeons about how to choose a breast reconstruction surgeon, what to expect during surgery, what is breast reconstruction, risks of breast reconstruction, recovery, costs, and questions to ask surgeon about breast reconstruction

Usual care American Society of Plastic Surgeons booklet "Breast Reconstruction"

-Interactive web based tool. Provides detail about breast reconstruction, asks participant questions about health and medications to personalize risks for breast reconstruction outcome. The tool also goes into pros/cons of breast reconstruction, talks about differences between types of reconstruction, helps people weigh when to have reconstruction (immediate vs. delayed), shows participants representative photos of breast reconstruction outcomes, and assesses patients' knowledge and preferences

* Section 1 Knowledge (primary outcome) - set of multiple choice questions about breast reconstruction, implants, flap surgeries, and side effects
* Section 2 Decisional Conflict Scale - 4 questions with yes/no answers dealing with participant's certainty about surgery (it total score less than 4, indicates higher decisional conflict)
* Section 3 Patient Activation Measures: 3 yes/no questions about participant's knowledge and trust of healthcare provider, sources of info about breast reconstruction, and different options available
* Section 4 Breast Reconstruction Decision Quality Instrument: 18 multiple choice questions about thought and processes that went into deciding about breast reconstruction
* Section 5 BREAST-Q: 3 questions about the breast reconstruction consultation appoint answers range from 0=no effort to 9=every effort.

Usual Care Group - Outcome Measures

* Section 1 Knowledge and Values Clarification Questions - set of multiple choice questions about the participants feelings on breast reconstruction, implants, flap surgeries, and side effects
* Section 2 Decisional Conflict SURE measure - 4 questions with yes/no answers dealing with participant's conflicts on surgery (if total score less than 4, indicates higher clinical significant decisional conflict)
* Section 3 Patient Activation Measures: 3 yes/no questions about participant's knowledge and trust of healthcare provider, sources of info about breast reconstruction, and different options available
* Section 4 Breast Reconstruction Decision Quality Instrument: 18 multiple choice questions about thought and processes that went into deciding about breast reconstruction (for those who have a clinical visit)
* Section 5 BREAST-Q: 3 questions about the breast reconstruction consultation appointment answers range from 0=no effort to 9=every effort (for those who have a clinical visit).

Decision Group - Outcome Measures

* Asks 15 questions
* Age, education, ethnicity, race, combined household income, zip code, disease stage, (3) questions about health insurance, (4) questions about participant's ability to work with numbers, heath literacy, health insurance status, and (1) question on if participant spoke to another provider about breast reconstruction decision

Demographic and Background Questions

Terence M Myckatyn, M.D.

Mary C Politi, Ph.D., MPH

Although clinical decision tools (CDTs) exist for a variety of treatments, CDTs designed to support personalized breast reconstruction decisions, particularly about type and timing of reconstruction, are lacking. The objective of this proposal is to develop and pilot test a clinical decision tool that provides personalized risk information and reflects patients' preferences and clinical needs.

Optimizing Decision Making About Breast Reconstruction After Mastectomy: A Patient-Centered Approach

To determine whether the CDT increases knowledge about their choice, the investigators will compare objective knowledge scores between participants using the CDT and those who received usual care

* To determine whether the CDT reduces uncertainty about choice. Participants are asked to report how sure they feel about their choice, if they have enough information to understand the choice, if they are clear about the risks and benefits, and if they have enough support to make a choice. Results are compared between the BREASTChoice and Enhanced Usual Care groups.
* Higher SURE values indicate certainty in choice
* Scores range from 0-4

* The total points are summed and then divided by the total number of items to result in scores from 0-100%, with higher scores indicating a more shared decision making process
* Assess the extent to which patients were meaningfully involved in decision-making with their clinicians

* Assessed 4 subscales: satisfaction with breasts, psychosocial well-being, physical well-being, and sexual well-being
* Score from 0 (worst) to 100 (best). Higher scores reflect a better outcome.

* Top collaboRATE score = the percentage of patients from whom there was 'gold standard' shared decision making as assessed by the collaboRATE measure
* The top score is coded as '1', if the response to all three collaboRATE items was less than 9. Then the investigators calculated the percentage of all encounters that were coded as '1' indicating gold standard shared decision making.

-3 questions consisting of the following:

* I am confident I can tell my healthcare provider concerns that I have about breast reconstruction even when he or she does not ask (confidence in healthcare provider)
* I am confident I can find trustworthy sources of information about my breast reconstruction decision (confidence in trustworthy sources)
* I know the different options available for breast reconstruction (knowledge on breast reconstruction options)

Assessed if participants received reconstruction

Assessed what type of reconstruction participants received

* Assessed timing of reconstruction
* Immediate is defined as reconstruction at the time of mastectomy
* Delayed is defined as reconstruction any time after the mastectomy and performed as a separate surgery

How long participants spent on the BREASTChoice tool

Assessed the time between when the plastic/reconstructive surgeon entered and exited the consult room (not including time spent with a resident, nurse, or other clinical staff)

* Assessed ease of usability of the BREASTChoice tool
* Scale is from 1 (strongly disagree) to 7 (strongly agree)

Washington University School of Medicine

Arm 1: BREASTChoice (Decision Tool)

Arm 2: Enhanced Usual Care (Surgical Care Booklet)

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Mary C. Politi, Ph.D.

Percent Correct on the Knowledge Measure (Objective Knowledge Score)

Decisional Conflict (SURE Measure)

Decision Process (Decision Quality Index Subscale)

Satisfaction with breasts

Psychosocial well-being

Physical well-being

Sexual well-being

Quality of Life as Measured by the BREAST-Q Questionnaire

3 participants from Arm 1 were excluded from the outcome measure as their data was missing. 1 participants from Arm 2 was excluded from the outcome measure as her data was missing.

Gold Standard Shared Decision Making as Measured by the Top collaboRATE Score

Confidence in healthcare provider

Confidence in trustworthy sources

Knowledge on breast reconstruction options

3 participants in the BREASTChoice arm did not provide an answer to this question and are not evaluable for this outcome measure.

Patient Activation (PAM) as Measured by the Number of Participants Who Agreed With Each Statement

No/Not yet started

Not applicable (breast-conserving surgery)

2 participants in the Enhanced Usual Care arm have not had their reconstruction surgery but are planning to schedule it but it is outside the follow-up window.

Receipt of Reconstruction

Implant

Flap

Unknown

Only patients who had reconstruction are applicable for this outcome measure

Type of Reconstruction

Immediate

Delayed

Timing of Reconstruction

-Only patients randomized to BREASTChoice (Decision Tool) are evaluable for this outcome measure

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Trial-specific Patient Decision Aid (tPDA) of the ImmunoSABR Phase 2	NCT04604470	NSCLC Stage IV Lung Cancer Non Small Cell ... Metastatic Canc...	Decision tool	18 Years -	Maastricht University
Optimizing Decision Making About Breast Reconstruction After Mastectomy: A Patient-Centered Approach	NCT03346161	Breast Cancer	Usual care Amer... Decision tool Usual Care Grou... Decision Group ... Demographic and...	18 Years -	Washington University School of Medicine
Trial-specific Patient Decision Aid (tPDA) of the ImmunoSABR Phase 2	NCT04604470	NSCLC Stage IV Lung Cancer Non Small Cell ... Metastatic Canc...	Decision tool	18 Years -	Maastricht University

Spots Global Cancer Trial Database for decision tool