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Trial Title:
Psychoeducation for Uveal Melanoma
NCT ID:
NCT06075589
Condition:
Uveal Melanoma
Conditions: Official terms:
Melanoma
Uveal Neoplasms
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Behavioral
Intervention name:
Education for Intervention
Description:
Participants watch two fifteen-minute educational videos and receive a mental health
resource information sheet on study.
Arm group label:
Arm 1
Other name:
Health Promotion and Education
Other name:
Questionnaire Administration
Intervention type:
Behavioral
Intervention name:
Best Practice
Description:
Patients receive enhanced treatment as usual and receive a mental health resource
information sheet on study.
Arm group label:
Arm II
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.
Criteria for eligibility:
Study pop:
- Failure to meet any of the above listed inclusion criteria
- (Self-reported or otherwise documented) Significant cognitive impairment that would
limit participants' ability to give informed consent, complete study questionnaires,
or ask/answer questions to/from study personnel
- Visual and hearing impairment rendering it difficult or impossible to watch, hear,
or comprehend the intervention videos
- Visual impairment and inability or unwillingness to identify a person (e.g., loved
one, caregiver) who can assist with the completion of study questionnaires
Sampling method:
Non-Probability Sample
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:
-
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of California at Los Angeles
Address:
City:
Los Angeles
Zip:
90095
Country:
United States
Status:
Recruiting
Contact:
Last name:
Megan Hoch
Phone:
310-794-6666
Email:
MHoch@mednet.ucla.edu
Start date:
November 7, 2023
Completion date:
December 1, 2026
Lead sponsor:
Agency:
Jonsson Comprehensive Cancer Center
Agency class:
Other
Source:
Jonsson Comprehensive Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06075589
