Clinical trial NCT06936813: The PROMISE Survey
Official title: Patients' and Physicians' Perspectives on the Management of Prolactinomas: Experiences, Treatment Preferences, and Related Outcomes - The PROMISE Survey
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Prolactinoma
Pituitary Tumor
Keywords: Survey
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2025-04-20
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Prolactinoma patients and physicians involved in the management of prolactinomas. Survey will be accessible globally via online patient communities, pituitary disorder organizations, physician networks, and in-clinic distribution.

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.

Eligibility criteria: Inclusion Criteria:

* Prolactinoma patients
* Prolactinoma treating physicians including endocrinologists and neurosurgeons

Primary outcomes:
measure: Generate hypotheses for future research
timeFrame: 6 months
Secondary outcomes:
measure: Collect data on patient characteristics
timeFrame: 6 months
measure: Assess patient experiences with dopamine agonist (DA) therapy
timeFrame: 6 months
measure: Evaluate patient experiences with surgical treatment
timeFrame: 6 months
measure: Collect data on diagnostic pathways
timeFrame: 6 months
measure: Evaluate patient-reported quality of life (QoL) and psychosocial impact
timeFrame: 6 months
measure: Assess physician perspectives on treatment strategies
timeFrame: 6 months
measure: Investigate patient and physician knowledge gaps
timeFrame: 6 months
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Cihan Atila
role: PRINCIPAL_INVESTIGATOR
References: