Psychoeducation for Uveal Melanoma

Jonsson Comprehensive Cancer Center

Status: Active, not recruiting

Conditions: Uveal Melanoma

Treatments: Behavioral: Education for Intervention; Behavioral: Best Practice

Study type: Interventional

Funder types: Other

Identifiers

NCT06075589

23-000414

Details and patient eligibility

About

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.

Full 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.

Enrollment: 108 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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108 participants in 2 patient groups

Arm 1

Active Comparator group

Description:

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

Treatment:

Behavioral: Education for Intervention

Arm II

Experimental group

Description:

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

Treatment:

Behavioral: Best Practice