Psychoeducation for Uveal Melanoma
- Conditions
- Uveal Melanoma
- Interventions
- Behavioral: Education for InterventionBehavioral: Best Practice
- Registration Number
- NCT06075589
- Lead Sponsor
- Jonsson Comprehensive Cancer Center
- 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.
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 108
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Arm 1 Education for Intervention Participants watch two fifteen-minute educational videos and receive a mental health resource information sheet on study. Arm II Best Practice Patients receive enhanced treatment as usual and receive a mental health resource information sheet on study.
- Primary Outcome Measures
Name Time Method Change in illness perceptions of chronicity From baseline to day 77 Will be assessed using the BIPQ will be examined across treatment and control conditions using multilevel models.
Change in illness perceptions of disease control 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.
Change in illness perceptions of coherence From baseline to day 77 Will be assessed using the BIPQ will be examined across treatment and control conditions using multilevel models.
- Secondary Outcome Measures
Name Time Method Domains of mental health: Depression 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.
Domains of mental health: Anxiety 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.
Trial Locations
- Locations (1)
University of California at Los Angeles
🇺🇸Los Angeles, California, United States