Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Quantitative study: Surveys: 1,067 out of a total of 1,389,725 people of residents of the Valencian Community, Spain. Three groups with quota control: proportional to age (40-50; 50-70; \> 70 years) of men aged 40 and over who have not had prostate cancer from each stratum (geographical area and population habitat).

Qualitative study: general population focus groups: 3

Quantitative study: 369 General Practitioners working in two Health Departments in the Valencian Community, Spain (Dept of Health Alicante, General Hospital 19, 255,439 habitants) and (Dept of Health Alicante, S Juan Alicante 17, 233,115 habitants).

Qualitative study: general practitioners focus groups: 2.

Quantitative study: 345 Urologists working in Valencian Community, Spain Qualitative study: urologists focus groups: 1.

Quantitative survey (cross-sectional design) and qualitative analysis (focus groups)

Mixed-method approach

In this project, the investigators aim to evaluate the most appropriate design and implementation strategy of a decision-aid to promote shared-decision making in prostate cancer screening.

Prostate cancer (PC) screening using Prostate Specific Antigen (PSA) has led to a reduction in advanced disease and disease-specific mortality. However, screening with PSA can also cause harm and is associated with false-positive results and overdiagnosis.

Shared-decision making (SDM) has been defined as the key to successful patient-centered care. The promotion SDM when deciding on PSA screening will have proximal effects such as the development of collaborative deliberation between clinicians and patients, resulting in well-informed patients and in preference-based decisions. As long term effects, it will result in safer, cost-effective, patient-aligned healthcare, and its distant effects will include improvements in resource use, planning processes and improved health outcomes.

The project includes a mixed-method approach. The investigators will perform a quantitative survey (cross-sectional design) to evaluate the population, patients' and clinicians' knowledge about the benefits and risks derived from the PSA determination and the available recommendations.

The investigators will apply qualitative analysis through focus groups, to explore the challenges patients and clinicians face to deep in a prostate screening discussion and to assess the adequacy of different implementation strategies.

The investigators will carry out a user-testing design based on mix-methods (questionnaire and semi-structured review) to evaluate the prototype of the initial decision-aid.

Finally, the investigators will carry out a cluster randomised controlled trial, to assess the results derived from the application of the decision-aid, together with a process evaluation using a combination of both qualitative and quantitative methods to monitor the fidelity of the intervention, the clusters' and patients' response to the intervention as well as the mechanisms of adaptation and change at the intervention.

Promoting Shared-decision Making in Opportunistic Screening for Prostate Cancer

Quantitative questionnaire to evaluate the target population and clinicians' knowledge about the PSA benefits/risks and the available recommendations. The investigators will develop an ad hoc questionnaire which will be validated through the Delphi Method.

Focus groups to explore qualitatively the challenge patients and clinicians face when discussing prostate cancer screening and to assess their preferences about different designs and implementation strategies.

The investigators will assess the number of patients who participate in a shared- decision making with their clinicians when receiving a PSA test. To assess it, the investigators, through a randomized clinical trial, will apply a new decision-aid developed to a group of patients which will be compared with another group which will have normal care.

Consorcio Centro de Investigación Biomédica en Red (CIBER)

Hospital de Sant Pau

Hospital Universitario San Juan de Alicante

Universidad Católica San Antonio de Murcia

Hospital General Universitario de Alicante

Universidad Miguel Hernandez de Elche

Professor

Symptoms and General Pathology

Respiratory Tract (Lung and Bronchial) Diseases

Neoplasm Metastasis

Lung Neoplasms

Carcinoma

Carcinoma, Non-Small-Cell Lung

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

The patients are offered high or lower dose according to usual practice

The Patient Decision Aid is used during the consultation to aid in the decision on high or lower dose.

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

A Patient Decision Aid

Thomas L Fink, MD

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.

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.

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.

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

Anonymized data will be available on relevant request.

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

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

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

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

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

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

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

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

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.

Vejle Hospital

Nervous System Diseases

Rare Diseases

Glioma

Glioblastoma

Brain Neoplasms

Astrocytoma

Oligodendroglioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Neuroepithelioma

Patients who receive pre-operativeinformation while the two-dimensional MR images are being shown to them by the neurosurgeon.

Patients who receive pre-operative information while the three-dimensional printed models are being shown to them by the neurosurgeon.

Three-dimensional printers are able to print physical objects in real size and colours. As a respresentative of the real tumor, a personalized three-dimensional model enables visualization of the patient-specific tumor and eloquent areas.

Three-dimensional printed model

Sümeyye Sezer, MD

Mark ter Laan, MD, PhD

Patient education plays an essential role in patient-centered care as it enhances patient satisfaction and information comprehension. However, about 40-80% of the information patients receive from healthcare professionals is forgotten and about half of the information patients remember is incorrect. To give informed consent, patients must be able to understand and recall the discussed information correctly. This is especially important in brain tumor patients, in which different treatment options determine outcome and risks. The goal of treatment in brain tumors is resection as completely as possible, without damaging healthy brain tissue. To this end, patients must understand the complex relation of the tumor to healthy brain tissue. This relation is different in each patient and three-dimensional (3D) in nature. Current two-dimensional visual tools lack the ability to properly display these complex 3D relations. In this study, we will investigate the effect of the use of 3D models in patient education, taking into account patient specific factors that might act as confounders. We will conduct a case control, multi-center study in the Radboud University Medical Center (Radboudumc) Maastricht University Medical Center (MUMC). Patients will be enrolled in the control group until inclusion for the control group is completed (n=30), after which patients will be enrolled in the intervention group (n=30). Patients will be cognitively tested using the Amsterdam Cognition Scale (ACS). After the consultation with their neurosurgeon, patients will be asked to fill out two questionnaires, consisting of two parts (patient experiences and information recall), one week apart.

Objectives The main goal of this project is to evaluate the role of 3D models on different aspects of patient education (patient experiences and information recall) in patients with brain tumors by comparing these to the use of standard 2D Magnetic Resonance (MR) images. A secondary goal is to gain more insight into the experiences of the close ones of the patients.

Study population We will conduct a case control, multi-center study in the Radboud University Medical Center (Radboudumc) Maastricht University Medical Center (MUMC). Patients will be enrolled in the control group until inclusion for the control group is completed (n=30), after which patients will be enrolled in the intervention group (n=30). The control group will consist of patients who will be informed using MR images during pre-operative consultations. The intervention group will be informed using personalized, life-size 3D models during pre-operative consultations. Inclusion time is estimated to be around 2 years.

Sample size Previous studies on this topic are scarce. In our experimental study on this subject \[Sezer et al. 2020\], we found an improvement of 5% (minimum expected difference, D) in information recall when using 3D models compared to 2D models. The standard deviation (SD) for information recall based on this study is approximately 5. With a significance criterion of 0.05 and power of 0.90 we calculated a total sample size of 42. For this study, however, we expect to find a smaller effect size due to the confounding factors (cognitive functioning, emotional status) which were eliminated in our experimental study in healthy individuals. Therefore we want to enroll 30 patients in each group (total sample size 60).

Study procedures Eligible patients will be asked to participate by their clinician or nurse practitioner who will they will receive an information letter and informed consent (attachment E1.1). The researcher will contact the patient to officially collect the informed consent form. Afterwards, the researcher will send out the link to the questionnaires collecting the baseline characteristics, emotional status questionnaire (HADS) and the ACS. The patient will be instructed to finish these questionnaires before the pre-operative consultation. Pre-operative preparation will be the same for the control and intervention group. The only difference will be the visual tool used in the pre-operative consult. Afterwards, the patient will be called by the researcher on the same or following day. A link will be sent out with the questionnaires on experiences, information recall and chosen treatment for the brain tumor. All questionnaires will be collected through Castor EDC © 2019.

The clinician will also be asked to fill out the questionnaire on information recall.

After the pre-operative consultation, we will ask the participant whether we can contact their close one. After reading the information letter and signing the informed consent the close one will receive the online questionnaires testing information recall and experiences. Both questionnaires will be collected through Castor EDC © 2019.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Promoting Shared-decision Making in Opportunistic Screening for Prostate Cancer	NCT05187949	Decision Making... Prostate-Specif... Prostate Cancer	Mixed-method ap...	-	Universidad Miguel Hernandez de Elche
Promoting Shared-decision Making in Opportunistic Screening for Prostate Cancer	NCT05187949	Decision Making... Prostate-Specif... Prostate Cancer	Mixed-method ap...	-	Universidad Miguel Hernandez de Elche
Shared Decision Making on Radiation Dose for Lung Malignancies	NCT04940936	Decision Making... Stereotactic Bo... Lung Cancer, No... Radiation Toxic... Lung Metastases	A Patient Decis...	18 Years -	Vejle Hospital
Shared Decision Making on Radiation Dose for Lung Malignancies	NCT04940936	Decision Making... Stereotactic Bo... Lung Cancer, No... Radiation Toxic... Lung Metastases	A Patient Decis...	18 Years -	Vejle Hospital
Educating Brain Tumor Patients Using Patient-specific Actual-size Three-dimensional Printed Models	NCT04970615	Brain Tumor Glioma Glioblastoma Astrocytoma Neoplasm, Brain Oligodendroglio... Patient Educati... Decision Making...	Three-dimension...	18 Years - 100 Years	Radboud University Medical Center

Spots Global Cancer Trial Database for decision making, shared