Young Melanoma Family Facebook Intervention or Healthy Lifestyle Facebook Intervention in Improving Skin Examination in Participants With Melanoma and Their Families

Clinical Stage III Cutaneous Melanoma AJCC v8 Clinical Trial

Official title:

Facebook Intervention for Young Onset Melanoma Patients and Families

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03677739
• Other study ID #: Pro2018001697
• Secondary ID: NCI-2018-01741Pr
• Status: Recruiting
• Phase: N/A
• Start date: June 3, 2019
• Est. completion date: December 1, 2024

Study information

• Verified date: January 2024
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1160
• Est. completion date: December 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• PATIENT: Diagnosed with stage 0-3 melanoma in the last 5 years

• PATIENT: Age at diagnosis 18-39 years

• PATIENT: Completed treatment at least 3 months previously

• PATIENT: Recruited from New Jersey or California State Cancer Registry or MD Anderson Cancer Center

• PATIENT: Does not have a concurrent cancer diagnosis

• PATIENT: Able to speak and read English

• PATIENT: Access to computer, internet, and has a Facebook account

• PATIENT: At least one family member consents

• FDR: Current age 18-80 years

• FDR: Does not have a personal history of melanoma

• FDR: Able to speak and read English

• FDR: Access to computer, internet, and has a Facebook account

• FDR: Has only one FDR with melanoma (patient)

• 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?)

• 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

Related Conditions & MeSH terms

• Clinical Stage 0 Cutaneous Melanoma AJCC v8
• Clinical Stage I Cutaneous Melanoma AJCC v8
• Clinical Stage IA Cutaneous Melanoma AJCC v8
• Clinical Stage IB Cutaneous Melanoma AJCC v8
• Clinical Stage II Cutaneous Melanoma AJCC v8
• Clinical Stage IIA Cutaneous Melanoma AJCC v8
• Clinical Stage IIB Cutaneous Melanoma AJCC v8
• Clinical Stage IIC Cutaneous Melanoma AJCC v8
• Clinical Stage III Cutaneous Melanoma AJCC v8
• First Degree Relative
• Melanoma
• Pathologic Stage 0 Cutaneous Melanoma AJCC v8
• Pathologic Stage I Cutaneous Melanoma AJCC v8
• Pathologic Stage IA Cutaneous Melanoma AJCC v8
• Pathologic Stage IB Cutaneous Melanoma AJCC v8
• Pathologic Stage II Cutaneous Melanoma AJCC v8
• Pathologic Stage IIA Cutaneous Melanoma AJCC v8
• Pathologic Stage IIB Cutaneous Melanoma AJCC v8
• Pathologic Stage IIC Cutaneous Melanoma AJCC v8
• Pathologic Stage III Cutaneous Melanoma AJCC v8
• Pathologic Stage IIIA Cutaneous Melanoma AJCC v8
• Pathologic Stage IIIB Cutaneous Melanoma AJCC v8
• Pathologic Stage IIIC Cutaneous Melanoma AJCC v8
• Skin Neoplasms

Intervention

Other:
• Informational Intervention
Receive information focusing on skin cancer
• Informational Intervention
Receive information on healthy lifestyle
• Survey Administration
Ancillary studies

Locations

Country	Name	City	State
United States	MD Anderson Cancer Center	Houston	Texas
United States	Rutgers Cancer Institute of New Jersey	New Brunswick	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mediator analyses - Intervention Group	Mediator analyses examining normative influences on the effects of intervention group on TCE, SSE and sun protection.	6 months
Other	Mediator analyses - (Relatives)	Mediator analyses examining family and peer support and discussion on the effects of intervention group on TCE, SSE and sun protection.	6 months
Other	Mediator analyses - Intervention Group - Risks	Mediator analyses examining risk on the effects of intervention group on TCE, SSE and sun protection.	6 months
Other	Mediator analyses - Intervention Group - Benefits	Mediator analyses examining benefits on the effects of intervention group on TCE, SSE and sun protection.	6 months
Other	Mediator analyses - Intervention Group - Barriers	Mediator analyses examining barriers on the effects of intervention group on TCE, SSE and sun protection.	6 months
Other	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
Other	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
Other	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
Other	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
Other	Moderator analysis - Residential Latitude	Moderator analysis residential latitude will explore whether the intervention group is more effective for subsets of FDRs.	6 months
Other	Moderator analysis - Sex	Moderator analysis sex will explore whether the intervention group is more effective for subsets of FDRs.	6 months
Other	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
Other	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
Other	Predictor - Engagement	Facebook engagement including likes, comments- collected at the end of the group	6 months
Other	Predictor - Social Network Use	Social network use measured by self-reported frequency of use of popular social media sites	6 months
Primary	Total cutaneous examination (TCE)	Will be assessed as a binary response (yes/no) did participant have one	At 6 months
Secondary	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
Secondary	Skin self-exam - Count Response (Relatives)	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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