Clinical trial · Observational
Patient Experience and Quality of Life During the Surveillance Phase of Uveal Melanoma: A Prospective Multi-method Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this prospective observational study is to learn about patient quality of life and experience and medical information needs during uveal melanoma post-treatment surveillance. Participants have previously undergone treatment for non-metastatic uveal melanoma and have integrated a oncological and / or ophthalmic surveillance protocol based on their individual genomic and / or clinical risk of recurrence. The main objectives it aims to assess are: * To evaluate the effect of satisfaction with communication with the oncologist/ophthalmologist during the oncology/ophthalmology surveillance visit 6 months after the start of surveillance (T1) on the overall level of health status/quality of life (QoL). * To explore the impact on psychosocial resources and needs such as fear of recurrence, anxiety and depression 6 months after the start of surveillance (T1) and 12 months after the start of surveillance (T2). * To document patients experience of care and communication during the first 12 months of surveillance. Participants will fill in quality of life questionnaires at two timepoints. A sub-sample will be offered to participate in qualitative research interviews. Researchers will compare data from patients at low risk of recurrence with those at high risk of recurrence to see if there are significant differences with regards to quality of life, satisfaction with care and medical information needs.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Uveal Melanoma | Uveal Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Questionnaires and interviews | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- To evaluate the effect of satisfaction with communication with the oncologist/ophthalmologist during the oncology/ophthalmology surveillance visit on the overall level of health status/quality of life (QoL).
- timeFrame
- At T1, 6 months after the start of surveillance.
- description
- EORTC QLQ-INFO25 item on overall satisfaction with information
Secondary outcomes (5)
- measure
- To document the experience of surveillance consultations for uveal melanoma patients at high risk of recurrence versus low risk of recurrence, from the point of view of patients and clinicians.
- timeFrame
- At T1, 6 months after the start of surveillance.
- description
- Communication experience will be assessed by analogue patient and clinician questions (perception of information and communication, knowledge related to examinations and prognostic testing, benefits and risks of providing medical information, particularly concerning the risk of metastatic recurrence). Furthermore, clinicians years of experience will be assessed.
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
* Patient aged 18 years or older.
* Diagnosed with a non-metastatic uveal melanoma
* Completion of primary tumour treatment ≥ 6 months (+/- two months).
* Able to respect scheduled visits.
* Able to read and understand the language of the questionnaires.
Two groups of patients will be identified:
1. Patients with non-metastatic uveal melanoma at high risk for metastatic relapse defined as:
* T2b/c/d or ≥ T3,
* or anomaly on either chromosome 3 or chromosome 8, found by CGH array or sequencing.
2. Patients with non-metastatic uveal melanoma at low risk of recurrence defined as:
* T2a,
* and/or no alteration of chromosome 3 or chromosome 8 has been found.References
Publications (1)
- DERIVEDMuller A, Dolbeault S, Piperno-Neumann S, Clerc M, Jarry P, Cassoux N, Lumbroso-Le Rouic L, Matet A, Rodrigues M, Holzner B, Malaise D, Bredart A. Anxiety, depression and fear of cancer recurrence in uveal melanoma survivors and ophthalmologist/oncologist communication during survivorship in France - protocol of a prospective observational mixed-method study. BMC Psychiatry. 2024 Nov 15;24(1):812. doi: 10.1186/s12888-024-06265-2. PMID 39548476