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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2018-00168 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| Pro20170000184 | |||
| 131704 | Other Identifier | Rutgers Cancer Institute of New Jersey | |
| P30CA072720 | U.S. NIH Grant/Contract | View source | |
| R01CA218068 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This randomized clinical trial studies how well social-media intervention works in reducing tanning in high-risk indoor and outdoor tanners. Social-media intervention delivered via Facebook may help to promote healthy behaviors, positive body image, and to understand young women's perception of a social media campaign.
PRIMARY OBJECTIVES:
I. To conduct a randomized control trial to examine the efficacy of the intervention versus (vs.) a Facebook-delivered control group on reducing tanning behavior among high-risk indoor and outdoor tanners.
OUTLINE: Participants are randomized to 1 of 2 groups.
GROUP I: Participants periodically read the content on the study-specific secret Facebook group related to living a healthy lifestyle including avoiding tanning and excessive ultraviolet exposure, managing stress, healthy eating, promoting physically active lifestyles, and promoting a healthy body image, and participate in the group by providing reactions, commenting on the posts, or by sharing study relevant information within the group for 8 weeks.
GROUP II: Participants participate in secret Facebook groups that utilize content from the intervention content library related to other health topics of interest (e.g., physical activity, healthy eating, alcohol misuse prevention, stress reduction, sleep) for 8 weeks.
After completion of study, patients are followed up at 3, 8, and 18 months post baseline assessment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I (focusing on tanning and healthy body image) | Experimental | Participants periodically read the content on the study-specific private and hidden Facebook group related to living a healthy lifestyle including avoiding tanning and excessive ultraviolet exposure, managing stress, healthy eating, promoting physically active lifestyles, and promoting a healthy body image, and participate in the group by providing reactions, commenting on the posts, or by sharing study relevant information within the group for 8 weeks. |
|
| Group II (focusing on other health topics) | Active Comparator | Participants participate in private and hidden Facebook groups that utilize content from the intervention content library related to other health topics of interest (e.g., physical activity, healthy eating, alcohol misuse prevention, stress reduction, sleep) for 8 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lifestyle and Values Intervention | Other | Participate in Facebook group focusing on avoiding tanning and promoting healthy body image |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total Tanning Sessions | Multilevel models (e.g., random coefficient) will be used to test the primary study hypothesis that participants who received the intervention will report less combined indoor and outdoor tanning behavior at a 8-month follow-up compared to those who received the control. If necessary, sensitivity analyses may control for individual-level covariates. For reporting purposes, total number of tanning session were summed. Items are measured on open-ended scales with minimum value of 0. Higher numbers report higher rates of tanning, a worse outcome considering it is a risk factor for skin cancer development. | At 8 months |
| Measure | Description | Time Frame |
|---|---|---|
| Indoor and Outdoor Tanning Behavior Assessed Using Surveys | Multilevel models (e.g., random coefficient) will be used. If necessary, sensitivity analyses may control for individual-level covariates. For reporting purposes, total number of tanning session were summed. Items are measured on open-ended scales with minimum value of 0. Higher numbers report higher rates of tanning, a worse outcome considering it is a risk factor for skin cancer development. |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jerod Stapleton, PhD | University of Kentucky | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kentucky | Lexington | Kentucky | 40536 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38502173 | Derived | Stapleton JL, Manne SL, Pagoto SL, Leip A, Greene K, Hillhouse JJ, Merritt AS, Shelton BJ. A Social Media-Delivered Melanoma Prevention Program for Young Women Engaged in Frequent UV Tanning: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2024 Mar 19;13:e56562. doi: 10.2196/56562. |
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Following screening, eligible participants who indicated their interest were emailed by study staff a link to a web-based baseline survey that also included the implied consent form. After completing the baseline survey, participants were randomized to condition.
Participants were primarily recruited by the internet research recruitment company Qualtrics Sample Providers. Qualtrics emailed a randomly selected sample frame of panel participants with a study invitation, which contained a brief description of the study procedures and a brief screening eligibility assessment. Qualtrics also supplemented recruitment with web advertisements posted on various websites and platforms of their partner organizations.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group I (Focusing on Tanning and Healthy Body Image) | Participants periodically read the content on the study-specific private and hidden Facebook group related to living a healthy lifestyle including avoiding tanning and excessive ultraviolet exposure, managing stress, healthy eating, promoting physically active lifestyles, and promoting a healthy body image, and participate in the group by providing reactions, commenting on the posts, or by sharing study relevant information within the group for 8 weeks. |
| FG001 | Group II (Focusing on Other Health Topics) | Participants participate in private and hidden Facebook groups that utilize content from the intervention content library related to other health topics of interest (e.g., physical activity, healthy eating, alcohol misuse prevention, stress reduction, sleep) for 8 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Group I (Focusing on Tanning and Healthy Body Image) | Participants periodically read the content on the study-specific private and hidden Facebook group related to living a healthy lifestyle including avoiding tanning and excessive ultraviolet exposure, managing stress, healthy eating, promoting physically active lifestyles, and promoting a healthy body image, and participate in the group by providing reactions, commenting on the posts, or by sharing study relevant information within the group for 8 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Total Tanning Sessions | Multilevel models (e.g., random coefficient) will be used to test the primary study hypothesis that participants who received the intervention will report less combined indoor and outdoor tanning behavior at a 8-month follow-up compared to those who received the control. If necessary, sensitivity analyses may control for individual-level covariates. For reporting purposes, total number of tanning session were summed. Items are measured on open-ended scales with minimum value of 0. Higher numbers report higher rates of tanning, a worse outcome considering it is a risk factor for skin cancer development. | Reported for survey completers | Posted | Mean | Standard Deviation | tanning sessions | At 8 months |
|
From enrollment to the long-term follow-up (up to 18-Months)
This is a minimal risk study. Participants were encouraged to report any concerns with participation to the study team.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group I (Focusing on Tanning and Healthy Body Image) | Participants periodically read the content on the study-specific private and hidden Facebook group related to living a healthy lifestyle including avoiding tanning and excessive ultraviolet exposure, managing stress, healthy eating, promoting physically active lifestyles, and promoting a healthy body image, and participate in the group by providing reactions, commenting on the posts, or by sharing study relevant information within the group for 8 weeks. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jerod Stapleton | University of Kentucky | 859 323 7224 | jerod.stapleton@uky.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 1, 2025 | Dec 3, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 29, 2024 | Feb 4, 2025 | ICF_000.pdf |
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| Lifestyle Intervention | Other | Participate in Facebook group focusing on other health topics |
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| Survey Administration | Other | Ancillary studies |
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| At 18 months |
| Skin Burns From Indoor and Outdoor Tanning Assessed Using Surveys | Multilevel models (e.g., random coefficient) will be used. If necessary, sensitivity analyses may control for individual-level covariates. Due to programming error in the study surveys, sunburn was not collected at 8 months as intended. Instead, data presented are from the 18-month, long-term follow-up. | At 18 months |
| Tanning Intentions Assessed Using Surveys | Multilevel models (e.g., random coefficient) will be used. If necessary, sensitivity analyses may control for individual-level covariates. Intentions for both indoor and outdoor tanning were summed to create a single intentions scale. Indoor tanning intentions were assessed with the question "How likely are you to indoor tan (e.g., used a tanning bed, sun lamp, or tanning booth) in the next 12 months?" and outdoor intentions with the question "How likely are you to sunbathe or spend time lying in the sun in the next 12 months?" Both questions included response options on a 6-point scale ranging from extremely unlikely (coded as "1") to extremely likely (coded as "6"). The range of possible responses was 2 to 12 with higher scores indicating higher intentions (a worse outcome). | At 8 months |
| BG001 | Group II (Focusing on Other Health Topics) | Participants participate in private and hidden Facebook groups that utilize content from the intervention content library related to other health topics of interest (e.g., physical activity, healthy eating, alcohol misuse prevention, stress reduction, sleep) for 8 weeks. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Indoor tanning sessions | Open-ended reporting of the number of times participants used a tanning bed or booth in the past 12 months | Mean | Standard Deviation | tanning sessions |
|
| Outdoor tanning sessions | Open-ended reporting of the number of times spent outdoor tanning in the most recent summer | Mean | Standard Deviation | tanning sessions |
|
| OG001 | Group II (Focusing on Other Health Topics) | Participants participate in private and hidden Facebook groups that utilize content from the intervention content library related to other health topics of interest (e.g., physical activity, healthy eating, alcohol misuse prevention, stress reduction, sleep) for 8 weeks. |
|
|
| Secondary | Indoor and Outdoor Tanning Behavior Assessed Using Surveys | Multilevel models (e.g., random coefficient) will be used. If necessary, sensitivity analyses may control for individual-level covariates. For reporting purposes, total number of tanning session were summed. Items are measured on open-ended scales with minimum value of 0. Higher numbers report higher rates of tanning, a worse outcome considering it is a risk factor for skin cancer development. | numbers are lower due to study attrition | Posted | Mean | Standard Deviation | tanning sessions | At 18 months |
|
|
|
| Secondary | Skin Burns From Indoor and Outdoor Tanning Assessed Using Surveys | Multilevel models (e.g., random coefficient) will be used. If necessary, sensitivity analyses may control for individual-level covariates. Due to programming error in the study surveys, sunburn was not collected at 8 months as intended. Instead, data presented are from the 18-month, long-term follow-up. | numbers differ due to attrition | Posted | Mean | Standard Deviation | number of sunburns | At 18 months |
|
|
|
| Secondary | Tanning Intentions Assessed Using Surveys | Multilevel models (e.g., random coefficient) will be used. If necessary, sensitivity analyses may control for individual-level covariates. Intentions for both indoor and outdoor tanning were summed to create a single intentions scale. Indoor tanning intentions were assessed with the question "How likely are you to indoor tan (e.g., used a tanning bed, sun lamp, or tanning booth) in the next 12 months?" and outdoor intentions with the question "How likely are you to sunbathe or spend time lying in the sun in the next 12 months?" Both questions included response options on a 6-point scale ranging from extremely unlikely (coded as "1") to extremely likely (coded as "6"). The range of possible responses was 2 to 12 with higher scores indicating higher intentions (a worse outcome). | numbers differ due to study attrition | Posted | Mean | Standard Deviation | score on a scale | At 8 months |
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|
|
| 0 |
| 204 |
| 0 |
| 204 |
| 0 |
| 204 |
| EG001 | Group II (Focusing on Other Health Topics) | Participants participate in private and hidden Facebook groups that utilize content from the intervention content library related to other health topics of interest (e.g., physical activity, healthy eating, alcohol misuse prevention, stress reduction, sleep) for 8 weeks. | 0 | 203 | 0 | 203 | 0 | 203 |
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