Young Melanoma Family Facebook Intervention or Healthy Lifestyle Facebook Intervention in Improving Skin Examination in Participants With Melanoma and Their Families
Study Details
Study Description
Brief Summary
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.
Detailed Description
PRIMARY OBJECTIVES:
- 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:
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To examine the efficacy of the Young Melanoma Family Facebook intervention on patients? skin self-exam frequency and comprehensiveness and sun protection habits.
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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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Arm 1 Young melanoma Family Facebook focusing on skin cancer Participants join a secret Young melanoma Family Facebook Group and view post messages focusing on skin cancer for 12 weeks. |
Other: Informational Intervention
Receive information focusing on skin cancer
Other: Survey Administration
Ancillary studies
|
| Experimental: Arm 2 Healthy Lifestyle Facebook focusing on healthy lifestyle Participants join a secret Healthy Lifestyle Facebook Group and view post messages focusing on healthy lifestyle for 12 weeks. |
Other: Informational Intervention
Receive information on healthy lifestyle
Other: Survey Administration
Ancillary studies
|
Outcome Measures
Primary Outcome Measures
- Total cutaneous examination (TCE) [At 6 months]
Will be assessed as a binary response (yes/no) did participant have one
Secondary Outcome Measures
- Skin Self-exam (Relatives) [Up to 5 years]
Skin self-exam of first degree relatives will be analyzed as a binary (yes/no) Response did participant complete one Yes/No
- Skin self-exam - Count Response (Relatives) [Up to 5 years]
Skin self exam of first degree relatives count response will be calculated as frequency/month. Frequency per month reported as a number.
- Skin self-exam - Comprehensiveness (Relatives) [Up to 5 years]
: Skin self-exam of first degree relatives comprehensiveness calculated as total # body parts examined during the skin self-exam
- Sun Protection Habits (Relatives) [Up to 5 years]
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).
- Skin self-exam - Count Response (Patients) [Up to 5 years]
Skin self-exam of patients count response calculated as (frequency/month). Frequency per month reported as a number
- Skin self-exam - Comprehensiveness (Patients) [Up to 5 years]
Skin self-exam of patients comprehensiveness calculated as total # body parts examined during the skin self-exam.
- Sun Protection Habits (Patients) [Up to 5 years]
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).
Other Outcome Measures
- Mediator analyses - Intervention Group [6 months]
Mediator analyses examining normative influences on the effects of intervention group on TCE, SSE and sun protection.
- Mediator analyses - (Relatives) [6 months]
Mediator analyses examining family and peer support and discussion on the effects of intervention group on TCE, SSE and sun protection.
- Mediator analyses - Intervention Group - Risks [6 months]
Mediator analyses examining risk on the effects of intervention group on TCE, SSE and sun protection.
- Mediator analyses - Intervention Group - Benefits [6 months]
Mediator analyses examining benefits on the effects of intervention group on TCE, SSE and sun protection.
- Mediator analyses - Intervention Group - Barriers [6 months]
Mediator analyses examining barriers on the effects of intervention group on TCE, SSE and sun protection.
- Mediator analyses - Intervention Group - Self-efficacy [6 months]
Mediator analyses examining self-efficacy on the effects of intervention group on TCE, SSE and sun protection.
- Mediator analyses - Intervention Group - Change Strategies [6 months]
Mediator analyses examining use of change strategies on the effects of intervention group on TCE, SSE and sun protection.
- Moderator analysis - Melanoma Risk Factors [6 months]
Moderator analysis Melanoma risk factors will explore whether the intervention group is more effective for subsets of FDRs.
- Moderator analysis - month of the year enrolled [6 months]
Moderator analysis month of the year enrolled will explore whether the intervention group is more effective for subsets of FDRs.
- Moderator analysis - Residential Latitude [6 months]
Moderator analysis residential latitude will explore whether the intervention group is more effective for subsets of FDRs.
- Moderator analysis - Sex [6 months]
Moderator analysis sex will explore whether the intervention group is more effective for subsets of FDRs.
- Moderator analysis - patient disease stage [6 months]
Moderator analysis patient disease stage will explore whether the intervention group is more effective for subsets of FDRs.
- Moderator analysis relationship to patient [6 months]
Moderator analysis relationship to patient will explore whether the intervention group is more effective for subsets of FDRs.
- Predictor - Engagement [6 months]
Facebook engagement including likes, comments- collected at the end of the group
- Predictor - Social Network Use [6 months]
Social network use measured by self-reported frequency of use of popular social media sites
Eligibility Criteria
Criteria
Inclusion Criteria:
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PATIENT: Diagnosed with stage 0-3 melanoma in the last 5 years
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PATIENT: Age at diagnosis 18-39 years
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PATIENT: Completed treatment at least 3 months previously
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PATIENT: Recruited from New Jersey or California State Cancer Registry or MD Anderson Cancer Center
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PATIENT: Does not have a concurrent cancer diagnosis
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PATIENT: Able to speak and read English
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PATIENT: Access to computer, internet, and has a Facebook account
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PATIENT: At least one family member consents
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FDR: Current age 18-80 years
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FDR: Does not have a personal history of melanoma
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FDR: Able to speak and read English
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FDR: Access to computer, internet, and has a Facebook account
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FDR: Has only one FDR with melanoma (patient)
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FDR: Has not had a total cutaneous examination (TCE) in the past 3 years, has done skin self-exam (SSE) fewer than three times in the past year, OR has a sun protection habits average score less than or equal to 4 (?often?)
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FDR: Patient consents
Exclusion Criteria:
- Physical Activity Readiness Questionnaire (Thomas, et. al., 1992): This 7-item scale will be used to screen out individuals who will need to consult a physician for medical clearance before engaging in physical activity. If a participant checks off any of the items, the investigators will ask for a physician clearance before consenting to study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey | United States | 08903 |
| 2 | MD Anderson Cancer Center | Houston | Texas | United States | 77030 |
Sponsors and Collaborators
- Rutgers, The State University of New Jersey
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Sharon Manne, Rutgers Cancer Institute of New Jersey
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Pro2018001697
- NCI-2018-01741
- Pro2018001697
- 131812
- 1R01CA221854-01A1