Psychoeducation for Uveal Melanoma

NCT06075589 | Active Not Recruiting

• 1 other identifier: 23-000414
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Uveal Melanoma

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Domains of mental health: Anxiety

  From baseline to day 77

• Domains of mental health: Depression

  From baseline to day 77

Study Arms (2)

Arm 1

ACTIVE COMPARATOR

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

Behavioral: Education for Intervention

Arm II

EXPERIMENTAL

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

Behavioral: Best Practice

Interventions

Education for Intervention BEHAVIORAL

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

Also known as: Health Promotion and Education, Questionnaire Administration

Arm 1

Best Practice BEHAVIORAL

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

Arm II

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Jonsson Comprehensive Cancer Center: lead

Study Sites (1)

University of California at Los Angeles

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Uveal Melanoma

Interventions

Educational Status; Methods; Health Promotion; Practice Guidelines 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

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics; Investigative Techniques; Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Anette Stanton, PhD

  University of Califonia at Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2023
• First Posted: October 10, 2023
• Study Start: November 7, 2023
• Primary Completion: August 14, 2024
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 19, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)