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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2018-01741 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| Pro2018001697 | |||
| 131812 | Other Identifier | Rutgers Cancer Institute of New Jersey | |
| 1R01CA221854-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This trial studies how well Young Melanoma Family Facebook intervention or Healthy Lifestyle Facebook intervention works in improving skin examination in participants with melanoma and their families. Young Melanoma Family Facebook intervention or Healthy Lifestyle Facebook intervention may help improve total cutaneous examinations, skin self-examinations, and sun protection among first degree relatives of young onset participants and the participants themselves.
PRIMARY OBJECTIVES:
I. To examine the efficacy of the Young Melanoma Family Facebook intervention versus the Healthy Lifestyle Facebook intervention on total cutaneous exam (primary outcome), skin self-exam frequency and comprehensiveness, and sun protection practices (secondary outcomes) of first degree relatives (FDRs) of young melanoma survivors.
SECONDARY OBJECTIVES:
I. To examine the efficacy of the Young Melanoma Family Facebook intervention on patients? skin self-exam frequency and comprehensiveness and sun protection habits.
II. To examine the mechanisms of intervention efficacy.
OUTLINE:
PHASE I: Researchers refine content for the Facebook intervention condition and conduct usability testing.
PHASE II: Participants are randomized to 1 of 2 arms.
ARM I: Participants join a secret Young Melanoma Family Facebook Group and view post messages focusing on skin cancer for 12 weeks.
ARM II: Participants join a secret Healthy Lifestyle Facebook Group and view post messages focusing on healthy lifestyle for 12 weeks.
PHASE III: Dissemination planning.
After completion of study, participants are followed up at 6 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 Young melanoma Family Facebook focusing on skin cancer | Experimental | Participants join a secret Young melanoma Family Facebook Group and view post messages focusing on skin cancer for 12 weeks. |
|
| Arm 2 Healthy Lifestyle Facebook focusing on healthy lifestyle | Experimental | Participants join a secret Healthy Lifestyle Facebook Group and view post messages focusing on healthy lifestyle for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Informational Intervention | Other | Receive information focusing on skin cancer |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total cutaneous examination (TCE) | Will be assessed as a binary response (yes/no) did participant have one | At 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Skin Self-exam (Relatives) | Skin self-exam of first degree relatives will be analyzed as a binary (yes/no) Response did participant complete one Yes/No | Up to 5 years |
| Skin self-exam - Count Response (Relatives) |
| Measure | Description | Time Frame |
|---|---|---|
| Mediator analyses - Intervention Group | Mediator analyses examining normative influences on the effects of intervention group on TCE, SSE and sun protection. | 6 months |
| Mediator analyses - (Relatives) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sharon Manne | Rutgers Cancer Institute of New Jersey | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey | 08903 | United States | ||
| MD Anderson Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36692933 | Derived | Manne S, Pagoto S, Peterson S, Heckman C, Kashy D, Berger A, Studts C, Negron R, Buller D, Paddock L, Gallo J, Kulik A, Frederick S, Pesanelli M, Domider M, Grosso M. Facebook Intervention for Young-Onset Melanoma Survivors and Families: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2023 Jan 24;12:e39640. doi: 10.2196/39640. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Sep 16, 2024 | Jan 17, 2025 |
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| Informational Intervention | Other | Receive information on healthy lifestyle |
|
| Survey Administration | Other | Ancillary studies |
|
Skin self exam of first degree relatives count response will be calculated as frequency/month. Frequency per month reported as a number.
| Up to 5 years |
| Skin self-exam - Comprehensiveness (Relatives) | : Skin self-exam of first degree relatives comprehensiveness calculated as total # body parts examined during the skin self-exam | Up to 5 years |
| Sun Protection Habits (Relatives) | sun protection habits score of first degree relatives will be calculated as continuous variables using the Sun protection behaviors scale (Glanz, et. al., 2002) which measures 5 behaviors (regular outdoor use of: sunscreen, hat, shade, long-sleeved shirt, sunglasses). | Up to 5 years |
| Skin self-exam - Count Response (Patients) | Skin self-exam of patients count response calculated as (frequency/month). Frequency per month reported as a number | Up to 5 years |
| Skin self-exam - Comprehensiveness (Patients) | Skin self-exam of patients comprehensiveness calculated as total # body parts examined during the skin self-exam. | Up to 5 years |
| Sun Protection Habits (Patients) | sun protection habits score of patients will be calculated as continuous variables using the Sun protection behaviors scale (Glanz, et. al., 2002) which measures 5 behaviors (regular outdoor use of: sunscreen, hat, shade, long-sleeved shirt, sunglasses). | Up to 5 years |
Mediator analyses examining family and peer support and discussion on the effects of intervention group on TCE, SSE and sun protection.
| 6 months |
| Mediator analyses - Intervention Group - Risks | Mediator analyses examining risk on the effects of intervention group on TCE, SSE and sun protection. | 6 months |
| Mediator analyses - Intervention Group - Benefits | Mediator analyses examining benefits on the effects of intervention group on TCE, SSE and sun protection. | 6 months |
| Mediator analyses - Intervention Group - Barriers | Mediator analyses examining barriers on the effects of intervention group on TCE, SSE and sun protection. | 6 months |
| Mediator analyses - Intervention Group - Self-efficacy | Mediator analyses examining self-efficacy on the effects of intervention group on TCE, SSE and sun protection. | 6 months |
| Mediator analyses - Intervention Group - Change Strategies | Mediator analyses examining use of change strategies on the effects of intervention group on TCE, SSE and sun protection. | 6 months |
| Moderator analysis - Melanoma Risk Factors | Moderator analysis Melanoma risk factors will explore whether the intervention group is more effective for subsets of FDRs. | 6 months |
| Moderator analysis - month of the year enrolled | Moderator analysis month of the year enrolled will explore whether the intervention group is more effective for subsets of FDRs. | 6 months |
| Moderator analysis - Residential Latitude | Moderator analysis residential latitude will explore whether the intervention group is more effective for subsets of FDRs. | 6 months |
| Moderator analysis - Sex | Moderator analysis sex will explore whether the intervention group is more effective for subsets of FDRs. | 6 months |
| Moderator analysis - patient disease stage | Moderator analysis patient disease stage will explore whether the intervention group is more effective for subsets of FDRs. | 6 months |
| Moderator analysis relationship to patient | Moderator analysis relationship to patient will explore whether the intervention group is more effective for subsets of FDRs. | 6 months |
| Predictor - Engagement | Facebook engagement including likes, comments- collected at the end of the group | 6 months |
| Predictor - Social Network Use | Social network use measured by self-reported frequency of use of popular social media sites | 6 months |
| Houston |
| Texas |
| 77030 |
| United States |
| ICF_000.pdf |