Uveal MelanomaNCT06075589
Psychoeducation for Uveal Melanoma
A study testing Education for Intervention and Best Practice in people with Uveal Melanoma, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Uveal Melanoma
- What is being tested?
- Education for Intervention and Best Practice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Nov 2023to 1 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California at Los Angeles
Los Angeles, California, 90095
About this study
Official title: Promoting Adjustment in Uveal Melanoma Survivorship: A Randomized Trial Targeting Illness Perceptions
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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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:
- 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.
- Conditions
- Uveal Melanoma
- Being tested
- Education for Intervention, Best Practice
- Medical subject headings
- Uveal Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education for InterventionBehavioural
Also called Health Promotion and Education, Questionnaire Administration
Participants watch two fifteen-minute educational videos and receive a mental health resource information sheet on study.
Best PracticeBehavioural
Patients receive enhanced treatment as usual and receive a mental health resource information sheet on study.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Active comparator | Participants watch two fifteen-minute educational videos and receive a mental health resource information sheet on study. Receives: Behavioral: Education for Intervention |
| Arm II | Experimental | Patients receive enhanced treatment as usual and receive a mental health resource information sheet on study. Receives: Behavioral: Best Practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in illness perceptions of disease control
Will be assessed using the Brief Illness Perception Questionnaire (BIPQ) and will be examined across treatment and control conditions using multilevel models.
Measured: From baseline to day 77
Change in illness perceptions of chronicity
Will be assessed using the BIPQ will be examined across treatment and control conditions using multilevel models.
Measured: From baseline to day 77
Change in illness perceptions of coherence
Will be assessed using the BIPQ will be examined across treatment and control conditions using multilevel models.
Measured: From baseline to day 77
Secondary outcomes (2)
Domains of mental health: Anxiety
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.
Measured: From baseline to day 77
Domains of mental health: Depression
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.
Measured: From baseline to day 77
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start7 Nov 2023
- Primary completion14 Aug 2024
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uveal MelanomaStudies of the same condition, open and under way.
- More trials run by Jonsson Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anette Stanton, PhD, Principal investigator, University of Califonia at Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06075589
- Sponsor's protocol ID
- 23-000414
- Status last verified
- Jan 2026
- First submitted
- 4 Oct 2023
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Adjustment in Uveal Melanoma Survivorship: A Randomized Trial Targeting Illness Perceptions
- ClinicalTrials.gov ID
- NCT06075589
- Acronym / sponsor ID
- 23-000414
- Conditions
- Uveal Melanoma
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Jonsson Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 7 Nov 2023 (actual)
- Primary completion
- 14 Aug 2024 (actual)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 10 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Active comparator | Behavioral: Education for InterventionParticipants watch two fifteen-minute educational videos and receive a mental health resource information sheet on study. |
| Arm II | Experimental | Behavioral: Best PracticePatients receive enhanced treatment as usual and receive a mental health resource information sheet on study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Education for InterventionAlso: Health Promotion and Education, Questionnaire AdministrationParticipants watch two fifteen-minute educational videos and receive a mental health resource information sheet on study. | Behavioural | Arm 1 |
| Best PracticePatients receive enhanced treatment as usual and receive a mental health resource information sheet on study. | Behavioural | Arm II |
Primary outcome
Change in illness perceptions of disease control
Time frame: 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
Time frame: 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
Time frame: From baseline to day 77
Will be assessed using the BIPQ will be examined across treatment and control conditions using multilevel models.
2 secondary outcomes
Domains of mental health: Anxiety
Time frame: From baseline to day 77
Domains of mental health: Depression
Time frame: From baseline to day 77
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anette Stanton, PhD principal investigator
University of Califonia at Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education for Intervention and Best Practice in people with Uveal Melanoma, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in illness perceptions of disease control (time frame: From baseline to day 77). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.