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Psychoeducation for Uveal Melanoma

Sponsor
Jonsson Comprehensive Cancer Center (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06075589
Collaborator
(none)
150
Enrollment
36
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Education for Intervention
  • Behavioral: Best Practice

Detailed Description

PRIMARY OBJECTIVE:
  1. 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:
  1. 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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
150 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Psychoeducation for Uveal Melanoma
Anticipated Study Start Date :
Dec 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2025
Anticipated Study Completion Date :
Dec 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Arm 1

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

Behavioral: Education for Intervention
Participants watch two fifteen-minute educational videos and receive a mental health resource information sheet on study.
Other Names:
  • Health Promotion and Education
  • Questionnaire Administration

    		•
    Arm II

    Patients receive enhanced treatment as usual 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.

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    2. 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.

    3. 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

    1. 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.

    2. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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:

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Jonsson Comprehensive Cancer Center

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jonsson Comprehensive Cancer Center
    ClinicalTrials.gov Identifier:
    NCT06075589
    Other Study ID Numbers:
    • 23-000414
    First Posted:
    Oct 10, 2023
    Last Update Posted:
    Oct 10, 2023
    Last Verified:
    Oct 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Melanoma
    Uveal Neoplasms

    Study Results

    No Results Posted as of Oct 10, 2023