Pituitary Tumor, Prolactinoma
Conditions
Keywords
Survey
Brief summary
The PROMISE Survey was developed to systematically assess the real-world experiences, treatment preferences, side effects, and outcomes from both patients and physicians dealing with prolactinomas. The aim is to generate insights that can guide future clinical research and improve individualized care strategies.
Detailed description
Background Prolactinomas are the most common hormone-producing pituitary tumors, causing symptoms like menstrual irregularities, infertility, galactorrhea, and reduced libido due to elevated prolactin levels. The standard treatment involves dopamine agonists (DAs) such as cabergoline or bromocriptine, which are usually effective. However, many patients report side effects (e.g., nausea, dizziness, psychiatric symptoms), leading to challenges in long-term adherence and uncertainty about outcomes after discontinuing therapy. Surgical treatment has emerged as a potentially safe and effective alternative, especially for selected patients, but perspectives from both patients and physicians on treatment preferences and outcomes are not well studied. The survey is designed to be completed in 5-10 minutes, fostering high participation across diverse patient and physician populations. Data are collected anonymous covers the following areas: 1. Patient Characteristics 2. DA Therapy 3. Surgical Treatment 4. Diagnostic Pathway 5. Treatment Side Effects & Recurrence 6. Quality of Life and Psychosocial Impact 7. Physician Perspectives 8. Knowledge Gaps 9. Hypothesis Generation Outcome The collected data will inform: * Better understanding of real-world management and challenges in prolactinoma care. * Insights for improving clinical guidelines, patient education, and treatment decision-making. * Hypotheses for future studies comparing outcomes of DA therapy vs. surgery and optimizing long-term management strategies.
Interventions
None listed
Sponsors
University Hospital, Basel, Switzerland
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
* Prolactinoma patients * Prolactinoma treating physicians including endocrinologists and neurosurgeons
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Generate hypotheses for future research | 6 months | Generate real-world patient-centered data to identify patterns in treatment outcomes, patient-reported challenges, and areas where additional clinical trials are needed to develop new hypothesis for future research |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Collect data on patient characteristics | 6 months | Distribution of patient demographics, cause of prolactinoma, additional pituitary disfunctions, symptom burden before diagnosis |
| Evaluate patient experiences with surgical treatment | 6 months | Percentage of patients who underwent surgery, rate of complications, remission, additional treatment |
| Collect data on diagnostic pathways | 6 months | Proportion of patients who underwent MRI or biochemical testing, number of consultations before diagnosis |
| Assess patient experiences with dopamine agonist (DA) therapy | 6 months | Distribution of DA types and dosing, side effects, remission |
| Assess physician perspectives on treatment strategies | 6 months | Distribution of first-line treatment preferences, criteria used for surgical referral, long-term monitoring, management strategies of endocrinologists and neurosurgeons |
| Investigate patient and physician knowledge gaps | 6 months | Awareness of alternative treatment options, concerns about recurrence risk after therapy discontinuation, fertility and pregnancy management, patient satisfaction with treatment-related education and counseling |
| Evaluate patient-reported quality of life (QoL) and psychosocial impact | 6 months | Quality of life (QoL) and employment or lifestyle limitations due to symptoms or medication side effects, psychological comorbidities |
Countries
Switzerland
Outcome results
None listed