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Active, Not Recruiting

NCT Number: NCT06075589

Psychoeducation for Uveal Melanoma

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Uveal Melanoma Eye Diseases Eye Neoplasms Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Uveal Diseases Uveal Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California at Los Angeles

Los Angeles, California, 90095, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Education for Intervention

Behavioral

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

Other names: Health Promotion and Education, Questionnaire Administration

Best Practice

Behavioral

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

Primary outcomes

  1. Change in illness perceptions of disease control

    Time frame: From baseline to day 77

    Will be assessed using the Brief Illness Perception Questionnaire (BIPQ) and will be examined across treatment and control conditions using multilevel models.

  2. Change in illness perceptions of chronicity

    Time frame: From baseline to day 77

    Will be assessed using the BIPQ will be examined across treatment and control conditions using multilevel models.

  3. Change in illness perceptions of coherence

    Time frame: From baseline to day 77

    Will be assessed using the BIPQ will be examined across treatment and control conditions using multilevel models.

Secondary outcomes

  1. Domains of mental health: Anxiety

    Time frame: From baseline to day 77

    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.

  2. Domains of mental health: Depression

    Time frame: From baseline to day 77

    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.

Sponsors and collaborators

Lead sponsor

Jonsson Comprehensive Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2027
First posted
Oct 10, 2023
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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