Clinical trial NCT06075589: Psychoeducation for Uveal Melanoma
Official title: Promoting Adjustment in Uveal Melanoma Survivorship: A Randomized Trial Targeting Illness Perceptions
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Uveal Melanoma
Lead sponsor: Jonsson Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2023-10-10
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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:

-

Primary outcomes:
measure: Change in illness perceptions of disease control
timeFrame: From baseline to day 77
measure: Change in illness perceptions of chronicity
timeFrame: From baseline to day 77
measure: Change in illness perceptions of coherence
timeFrame: From baseline to day 77
Secondary outcomes:
measure: Domains of mental health: Anxiety
timeFrame: From baseline to day 77
measure: Domains of mental health: Depression
timeFrame: From baseline to day 77
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California at Los Angeles
state: California
Study officials:
affiliation: University of Califonia at Los Angeles
name: Anette Stanton, PhD
role: PRINCIPAL_INVESTIGATOR
References: