Uveal Melanoma
Conditions
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.
Interventions
BEHAVIORALEducation for Intervention
Participants watch two fifteen-minute educational videos and receive a mental health resource information sheet on study.
BEHAVIORALBest Practice
Patients receive enhanced treatment as usual and receive a mental health resource information sheet on study.
Sponsors
Jonsson Comprehensive Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 coherence | From baseline to day 77 | Will be assessed using the BIPQ will be examined across treatment and control conditions using multilevel models. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAnette Stanton, PhD
University of Califonia at Los Angeles
Outcome results
None listed