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

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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Yes
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 80 Years
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03677739
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Rutgers, The State University of New Jersey
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Sharon Manne
Principal Investigator Affiliation	Rutgers Cancer Institute of New Jersey
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other, NIH
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	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

Additional Details

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.

Arms & Interventions

Arms

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.

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.

Interventions

Other: - Informational Intervention

Receive information focusing on skin cancer

Other: - Informational Intervention

Receive information on healthy lifestyle

Other: - Survey Administration

Ancillary studies

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey

Status

Recruiting

Address

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903

Site Contact

Sharon Manne

[email protected]

732-235-6759

MD Anderson Cancer Center, Houston, Texas

Status