Psychoeducation for Uveal Melanoma

Promoting Adjustment in Uveal Melanoma Survivorship: A Randomized Trial Targeting Illness Perceptions

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Uveal Melanoma
• Intervention / Treatment: Behavioral: Education for Intervention; Behavioral: Best Practice

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 108
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • University of California at Los Angeles

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Study Population

• Failure to meet any of the above listed inclusion criteria
• (Self-reported or otherwise documented) Significant cognitive impairment that would limit participants' ability to give informed consent, complete study questionnaires, or ask/answer questions to/from study personnel
• Visual and hearing impairment rendering it difficult or impossible to watch, hear, or comprehend the intervention videos
• Visual impairment and inability or unwillingness to identify a person (e.g., loved one, caregiver) who can assist with the completion of study questionnaires

Description

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:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm 1; Participants watch two fifteen-minute educational videos and receive a mental health resource information sheet on study.	Behavioral: Education for Intervention; Participants watch two fifteen-minute educational videos and receive a mental health resource information sheet on study.; Other Names: Questionnaire Administration; Health Promotion and Education
Experimental: Arm II; Patients receive enhanced treatment as usual and receive a mental health resource information sheet on study.	Behavioral: Best Practice; Patients receive enhanced treatment as usual and receive a mental health resource information sheet on study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Jonsson Comprehensive Cancer Center
• Investigators: Principal Investigator: Anette Stanton, PhD, University of Califonia at Los Angeles

Study record dates

Study Major Dates

• Study Start (Actual): November 7, 2023
• Primary Completion (Actual): August 14, 2024
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: October 4, 2023
• First Submitted That Met QC Criteria: October 4, 2023
• First Posted (Actual): October 10, 2023

Study Record Updates

• Last Update Posted (Actual): March 19, 2026
• Last Update Submitted That Met QC Criteria: March 17, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Eye Diseases; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Eye Neoplasms; Uveal Diseases; Melanoma; Uveal Neoplasms; Uveal Melanoma; Health Services Administration; Health Care Quality, Access, and Evaluation; Investigative Techniques; Quality of Health Care; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services; Socioeconomic Factors; Population Characteristics; Guidelines as Topic; Quality Assurance, Health Care; Health Education; Methods; Educational Status; Practice Guidelines as Topic; Health Promotion
• Other Study ID Numbers: 23-000414

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No