Clinical trial NCT03677739: Young Melanoma Family Facebook Intervention or Healthy Lifestyle Facebook Intervention in Improving Skin Examination in Participants With Melanoma and Their Families
Official title: Facebook Intervention for Young Onset Melanoma Patients and Families
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2018-09-19
Enrollment: 1160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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:

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.

Eligibility criteria: 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

Primary outcomes:
measure: Total cutaneous examination (TCE)
timeFrame: At 6 months
Secondary outcomes:
measure: Skin Self-exam (Relatives)
timeFrame: Up to 5 years
measure: Skin self-exam - Count Response (Relatives)
timeFrame: Up to 5 years
measure: Skin self-exam - Comprehensiveness (Relatives)
timeFrame: Up to 5 years
measure: Sun Protection Habits (Relatives)
timeFrame: Up to 5 years
measure: Skin self-exam - Count Response (Patients)
timeFrame: Up to 5 years
measure: Skin self-exam - Comprehensiveness (Patients)
timeFrame: Up to 5 years
measure: Sun Protection Habits (Patients)
timeFrame: Up to 5 years
Other outcomes:
measure: Mediator analyses - Intervention Group
timeFrame: 6 months
measure: Mediator analyses - (Relatives)
timeFrame: 6 months
measure: Mediator analyses - Intervention Group - Risks
timeFrame: 6 months
measure: Mediator analyses - Intervention Group - Benefits
timeFrame: 6 months
measure: Mediator analyses - Intervention Group - Barriers
timeFrame: 6 months
measure: Mediator analyses - Intervention Group - Self-efficacy
timeFrame: 6 months
measure: Mediator analyses - Intervention Group - Change Strategies
timeFrame: 6 months
measure: Moderator analysis - Melanoma Risk Factors
timeFrame: 6 months
measure: Moderator analysis - month of the year enrolled
timeFrame: 6 months
measure: Moderator analysis - Residential Latitude
timeFrame: 6 months
measure: Moderator analysis - Sex
timeFrame: 6 months
measure: Moderator analysis - patient disease stage
timeFrame: 6 months
measure: Moderator analysis relationship to patient
timeFrame: 6 months
measure: Predictor - Engagement
timeFrame: 6 months
measure: Predictor - Social Network Use
timeFrame: 6 months
Locations:
city: New Brunswick
country: United States
facility: Rutgers Cancer Institute of New Jersey
state: New Jersey
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: Rutgers Cancer Institute of New Jersey
name: Sharon Manne
role: PRINCIPAL_INVESTIGATOR
References: