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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Active Comparator | Participants watch two fifteen-minute educational videos and receive a mental health resource information sheet on study. |
|
| Arm II | Experimental | Patients receive enhanced treatment as usual and receive a mental health resource information sheet on study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Education for Intervention | Behavioral | Participants watch two fifteen-minute educational videos and receive a mental health resource information sheet on study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | From baseline to day 77 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From baseline to day 77 |
| Domains of mental health: Depression |
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Inclusion Criteria:
Exclusion Criteria:
-
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| Name | Affiliation | Role |
|---|---|---|
| Anette Stanton, PhD | University of Califonia at Los Angeles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California at Los Angeles | Los Angeles | California | 90095 | United States |
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| ID | Term |
|---|---|
| D000098943 | Uveal Melanoma |
| ID | Term |
|---|---|
| D008545 | Melanoma |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
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| ID | Term |
|---|---|
| D004522 | Educational Status |
| D008722 | Methods |
| D006293 | Health Promotion |
| D017410 | Practice Guidelines as Topic |
| ID | Term |
|---|---|
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
| D008919 | Investigative Techniques |
| D006266 | Health Education |
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|
| Best Practice | Behavioral | Patients receive enhanced treatment as usual and receive a mental health resource information sheet on study. |
|
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. |
| From baseline to day 77 |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D014604 | Uveal Neoplasms |
| D005134 | Eye Neoplasms |
| D009371 | Neoplasms by Site |
| D005128 | Eye Diseases |
| D014603 | Uveal Diseases |
| D011314 | Preventive Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D017408 | Guidelines as Topic |
| D011785 | Quality Assurance, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |