Psychoeducation for Uveal Melanoma

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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:

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06075589
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Jonsson Comprehensive Cancer Center
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Anette Stanton, PhD
Principal Investigator Affiliation	University of Califonia at Los Angeles
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Uveal Melanoma

Additional Details

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.

Arms & Interventions

Arms

: Arm 1

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

Behavioral: - Education for Intervention

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

Behavioral: - Best Practice

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of California at Los Angeles, Los Angeles, California

Status

Recruiting

Address

University of California at Los Angeles

Los Angeles, California, 90095

Site Contact

Megan Hoch

[email protected]

310-794-6666

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