Psychoeducation for Uveal Melanoma

Uveal Melanoma Clinical Trial

Official title:

Psychoeducation for Uveal Melanoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06075589
• Other study ID #: 23-000414
• Status: Recruiting
• Start date: November 7, 2023
• Est. completion date: December 1, 2026

Study information

• Verified date: October 2023
• Source: Jonsson Comprehensive Cancer Center
• Contact: Megan Hoch
• Phone: (310) 794-6666
• Email: MHoch[@]mednet.ucla.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This clinical trial evaluates a video-based psychoeducational intervention for patients with uveal melanoma. Uveal melanoma (UM) is a rare intraocular cancer. UM patients face an uncertain course of survivorship in terms of their visual acuity, treatment-related side effects, and risk for eventual metastasis of the cancer. Learning about patients' thoughts and reactions to informational resources may better support patients during ocular melanoma survivorship.

Description:

PRIMARY OBJECTIVE:

I. To assess the efficacy of the psychoeducation intervention (compared to the control condition) in modifying illness perceptions of disease control, chronicity, and coherence (i.e., to become less threatening) over the course of the follow-up period.

SECONDARY OBJECTIVE:

I. To assess the efficacy of the psychoeducation intervention (compared to the control condition) in reducing the degree of participant's depressive and anxiety symptoms over the course of the follow-up period.

OUTLINE: Participants are randomized to 1 of 2 arms.

ARM I: Participants watch two fifteen-minute educational videos and receive a mental health resource information sheet on study.

ARM II: Patients receive enhanced treatment as usual and receive a mental health resource information sheet on study.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 1, 2026
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adults (age 18 years and older at visit 1)

• History of uveal melanoma as documented in their University of California, Los Angeles (UCLA) medical record

• Receipt of uveal melanoma treatment and/or ongoing follow-up care at the UCLA Jules Stein Eye Institute, as documented in their UCLA medical record

• Ability to read, write, and converse in English

• Access to the internet via a computer or cell phone

• Access to a personal email address

• Written informed consent obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Melanoma
• Uveal Melanoma
• Uveal Neoplasms

Intervention

Behavioral:
• Education for Intervention
Participants watch two fifteen-minute educational videos and receive a mental health resource information sheet on study.
• Best Practice
Patients receive enhanced treatment as usual and receive a mental health resource information sheet on study.

Locations

Country	Name	City	State
United States	University of California at Los Angeles	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Jonsson Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in illness perceptions of disease control	Will be assessed using the Brief Illness Perception Questionnaire (BIPQ) and will be examined across treatment and control conditions using multilevel models.	From baseline to day 77
Primary	Change in illness perceptions of chronicity	Will be assessed using the BIPQ will be examined across treatment and control conditions using multilevel models.	From baseline to day 77
Primary	Change in illness perceptions of coherence	Will be assessed using the BIPQ will be examined across treatment and control conditions using multilevel models.	From baseline to day 77
Secondary	Domains of mental health: Anxiety	Will be assessed by multilevel models of anxiety symptoms as functions of treatment condition (i.e., group assignment). Anxiety symptoms will be assessed at all assessment points with the Generalized Anxiety Disorder Scale-7.	From baseline to day 77
Secondary	Domains of mental health: Depression	Will be assessed by multilevel models of depression symptoms as functions of treatment condition (i.e., group assignment). Depressive symptoms will be assessed at all assessment points with the well-validated 20-item Center for Epidemiologic Studies-Depression Scale.	From baseline to day 77