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

NCT03677739 | Active Not Recruiting DMC

• 4 other identifiers: Pro2018001697NCI-2018-017411318121R01CA221854-01A1
• Study Type: interventional
• Target: 1,160
• Locations: 1 country
• Sites: 2

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.

Conditions

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; 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

Outcome Measures

Primary Outcomes (1)

• Total cutaneous examination (TCE)

  Will be assessed as a binary response (yes/no) did participant have one

  At 6 months

Secondary Outcomes (7)

• Skin Self-exam (Relatives)

  Up to 5 years

• Skin self-exam - Count Response (Relatives)

  Up to 5 years

• Skin self-exam - Comprehensiveness (Relatives)

  Up to 5 years

• Sun Protection Habits (Relatives)

  Up to 5 years

• Skin self-exam - Count Response (Patients)

  Up to 5 years

Other Outcomes (15)

• Mediator analyses - Intervention Group

  6 months

• Mediator analyses - (Relatives)

  6 months

• Mediator analyses - Intervention Group - Risks

  6 months

Study Arms (2)

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.

Other: Informational Intervention; Other: Survey Administration

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.

Other: Informational Intervention; Other: Survey Administration

Interventions

Informational Intervention OTHER

Receive information focusing on skin cancer

Arm 1 Young melanoma Family Facebook focusing on skin cancer

Survey Administration OTHER

Ancillary studies

Arm 1 Young melanoma Family Facebook focusing on skin cancer; Arm 2 Healthy Lifestyle Facebook focusing on healthy lifestyle

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

• 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.

  PMID: 36692933 DERIVED

Study Officials

• Sharon Manne

  Rutgers Cancer Institute of New Jersey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: August 24, 2018
• First Posted: September 19, 2018
• Study Start: June 3, 2019
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: October 1, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)