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

Facebook Intervention for Young Onset Melanoma Patients and Families

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.

Study Overview

• Status: Recruiting
• Conditions: Clinical Stage III Cutaneous Melanoma AJCC v8; Pathologic Stage IIIB Cutaneous Melanoma AJCC v8; Pathologic Stage IIIC Cutaneous Melanoma AJCC v8; 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; First Degree Relative; 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
• Intervention / Treatment: Other: Survey Administration; Other: Informational Intervention; Other: Informational Intervention

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 1160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • New Brunswick, New Jersey, United States, 08903
      • Recruiting
      • Rutgers Cancer Institute of New Jersey
      • Contact: Sharon Manne; Phone Number: 732-235-6759; Email: mannesl@cinj.rutgers.edu
      • Principal Investigator: Sharon Manne
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • MD Anderson Cancer Center
      • Contact: Susan Peterson, PhD; Phone Number: 713-792-8267; Email: speterso@mdanderson.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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: Survey Administration; Ancillary studies; Other: Informational Intervention; Receive information focusing on skin cancer; Other: Informational Intervention; Receive information on healthy lifestyle
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: Survey Administration; Ancillary studies; Other: Informational Intervention; Receive information focusing on skin cancer; Other: Informational Intervention; Receive information on healthy lifestyle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total cutaneous examination (TCE)	Will be assessed as a binary response (yes/no) did participant have one	At 6 months

Secondary Outcome Measures

Outcome Measure	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)	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

Other Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: Rutgers, The State University of New Jersey
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Sharon Manne, Rutgers Cancer Institute of New Jersey

Study record dates

Study Major Dates

• Study Start (Actual): June 3, 2019
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: August 24, 2018
• First Submitted That Met QC Criteria: September 17, 2018
• First Posted (Actual): September 19, 2018

Study Record Updates

• Last Update Posted (Estimated): January 31, 2024
• Last Update Submitted That Met QC Criteria: January 30, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Melanoma; Skin Neoplasms
• Other Study ID Numbers: Pro2018001697; NCI-2018-01741 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); 131812 (Other Identifier: Rutgers Cancer Institute of New Jersey); 1R01CA221854-01A1 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No