Psychoeducation for Uveal Melanoma

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Psychoeducation for Uveal Melanoma

Conditions
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Uveal Melanoma

Intervention / Treatment
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* Behavioral: Education for Intervention
* Behavioral: Best Practice


Participation Criteria
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Eligibility Criteria
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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: -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Arm 1<br>Participants watch two fifteen-minute educational videos and receive a mental health resource information sheet on study. | Behavioral: Education for Intervention<br>* Participants watch two fifteen-minute educational videos and receive a mental health resource information sheet on study.<br>* Other names: Questionnaire Administration;|
| Arm II<br>Patients receive enhanced treatment as usual and receive a mental health resource information sheet on study. | Behavioral: Best Practice<br>* Patients receive enhanced treatment as usual and receive a mental health resource information sheet on study.<br>|

What is the study measuring?
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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 |