Patient Experience and Quality of Life During the Surveillance Phase of Uveal Melanoma: A Prospective Multi-method Study

NCT06073548 | Not Yet Recruiting

• 1 other identifier: IC 2022-11
• Study Type: observational
• Target: 250
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Uveal Melanoma

Keywords

Uveal Melanoma; Ophtalmic oncology; Quality of life; Fear of recurrence; Communication

Outcome Measures

Primary Outcomes (1)

• 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).

  EORTC QLQ-INFO25 item on overall satisfaction with information

  At T1, 6 months after the start of surveillance.

Secondary Outcomes (5)

• 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.

  At T1, 6 months after the start of surveillance.

• To document the satisfaction of patients at high and low risk of metastatic recurrence with organization of the surveillance phase (e.g. coordination, continuity of care).

  At T1 (i.e. 6 months from the start of the surveillance phase).

• To evaluate the effect of satisfaction of patients at high versus low risk of recurrence with regard to communication with the oncologist / ophthalmologist on fear of recurrence.

  At T1 and then at T2 (i.e. at six and 12 months from the start of the surveillance phase).

• To explore coping strategies and preferences with regard to medical information, particularly concerning medical examinations and prognostic tests, in patients at high and low risk of metastatic recurrence.

  At T1 (i.e. 6 months from the start of the surveillance phase).

• To identify the psycho-social needs and assess the quality of life (e.g. anxiety, depression) of patients at high and low risk of metastatic recurrence, as well as changes in these needs over time.

  At inclusion and then at T2 (i.e. 6 and 12 months respectively from the start of the oncological surveillance phase).

Interventions

Questionnaires and interviews OTHER

Patients wiill be asked to fulfill questionnaires at inclusion and 6 months after. An interview will be offered to a sub-sample of patients (approximately 20 patients).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Newly patients undergoing surveillance for non-metastatic UM will be consecutively included either at the oncologist (for high-risk patients) or ophthalmologist (for low risk patients) consultation. Those at high risk of metastatic recurrence are those taking part of a cohort including 700 patients with non-metastatic uveal melanoma at high risk of metastatic recurrence, whose aim is to provide intensive clinical surveillance (MRI every 6 months) based on risk of UM metastatic recurrence. Patients at low risk of metastatic recurrence are followed by the ophthalmologist and receive liver ultrasound every 6 months.

* 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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Institut Curie: lead

Related Publications (1)

• Muller 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 DERIVED

MeSH Terms

Conditions

Uveal Melanoma; Communication

Interventions

Surveys and Questionnaires; Interviews as Topic

Condition Hierarchy (Ancestors)

Melanoma; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Uveal Neoplasms; Eye Neoplasms; Neoplasms by Site; Eye Diseases; Uveal Diseases; Behavior

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Anne BREDART

CONTACT

anne.bredart@curie.fr

Anita MULLER

CONTACT

anita.muller@curie.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2023
• First Posted: October 10, 2023
• Study Start: October 1, 2023
• Primary Completion: October 1, 2025
• Study Completion: April 1, 2026
• Last Updated: October 10, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share