Clinical Stage 0 Cutaneous Melanoma AJCC v8NCT03677739
Young Melanoma Family Facebook Intervention or Healthy Lifestyle Facebook Intervention in Improving Skin Examination in Participants With Melanoma and Their Families
A study testing Informational Intervention and Survey Administration in people with Clinical Stage 0 Cutaneous Melanoma AJCC v8 and Clinical Stage I Cutaneous Melanoma AJCC v8, run by Rutgers, The State University of New Jersey at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Clinical Stage 0 Cutaneous Melanoma AJCC v8, Clinical Stage I Cutaneous Melanoma AJCC v8, Clinical Stage IA Cutaneous Melanoma AJCC v8
- What is being tested?
- Informational Intervention and Survey Administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,160 participants
- Where
- 2 sitesUnited States
- Study dates
- 3 Jun 2019to 31 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 15Show fewer
- 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
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
United States2 sites
MD Anderson Cancer Center
Houston, Texas, 77030
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
About this study
Official title: 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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
- 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
- Being tested
- Informational Intervention, Survey Administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Informational InterventionOther
Receive information focusing on skin cancer
Informational InterventionOther
Receive information on healthy lifestyle
Survey AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Informational Intervention; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total cutaneous examination (TCE)
Will be assessed as a binary response (yes/no) did participant have one
Measured: At 6 months
Secondary outcomes (7)
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
Measured: 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.
Measured: 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
Measured: 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).
Measured: 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
Measured: 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.
Measured: 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).
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2018
- Study start3 Jun 2019
- Primary completion31 Dec 2025
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Clinical Stage 0 Cutaneous Melanoma AJCC v8Studies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Sharon Manne, PhD, Rutgers Cancer Institute of New Jersey
- Investigators
- Sharon Manne, Principal investigator, Rutgers Cancer Institute of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03677739
- Sponsor's protocol ID
- Pro2018001697
- Other IDs
- NCI-2018-01741, Pro2018001697, 131812, 1R01CA221854-01A1
- Status last verified
- May 2026
- First submitted
- 24 Aug 2018
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36692933
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Facebook Intervention for Young Onset Melanoma Patients and Families
- ClinicalTrials.gov ID
- NCT03677739
- Acronym / sponsor ID
- Pro2018001697
- 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
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,160 participants (estimated)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 3 Jun 2019 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 19 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 Young melanoma Family Facebook focusing on skin cancer | Experimental | Other: Informational Intervention, Other: Survey AdministrationParticipants join a secret Young melanoma Family Facebook Group and view post messages focusing on skin cancer for 12 weeks. |
| Arm 2 Healthy Lifestyle Facebook focusing on healthy lifestyle | Experimental | Other: Informational Intervention, Other: Survey AdministrationParticipants join a secret Healthy Lifestyle Facebook Group and view post messages focusing on healthy lifestyle for 12 weeks. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Informational InterventionReceive information focusing on skin cancer | Other | Arm 1 Young melanoma Family Facebook focusing on skin cancer |
| Informational InterventionReceive information on healthy lifestyle | Other | Arm 2 Healthy Lifestyle Facebook focusing on healthy lifestyle |
| Survey AdministrationAncillary studies | Other | Arm 1 Young melanoma Family Facebook focusing on skin cancer, Arm 2 Healthy Lifestyle Facebook focusing on healthy lifestyle |
Primary outcome
Total cutaneous examination (TCE)
Time frame: At 6 months
Will be assessed as a binary response (yes/no) did participant have one
7 secondary outcomes
Skin Self-exam (Relatives)
Time frame: Up to 5 years
Skin self-exam - Count Response (Relatives)
Time frame: Up to 5 years
Skin self-exam - Comprehensiveness (Relatives)
Time frame: Up to 5 years
Sun Protection Habits (Relatives)
Time frame: Up to 5 years
Skin self-exam - Count Response (Patients)
Time frame: Up to 5 years
Skin self-exam - Comprehensiveness (Patients)
Time frame: Up to 5 years
Sun Protection Habits (Patients)
Time frame: Up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Derived from this study: PubMed 36692933Manne 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sharon Manne principal investigator
Rutgers Cancer Institute of New Jersey
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Informational Intervention and Survey Administration in people with Clinical Stage 0 Cutaneous Melanoma AJCC v8 and Clinical Stage I Cutaneous Melanoma AJCC v8, run by Rutgers, The State University of New Jersey at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total cutaneous examination (TCE) (time frame: At 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03677739, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.