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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

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ClinicalTrials.gov Identifier: NCT03677739
Recruitment Status : Recruiting
First Posted : September 19, 2018
Last Update Posted : September 17, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Sharon Manne, PhD, Rutgers Cancer Institute of New Jersey

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.

Condition or disease Intervention/treatment Phase
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 Other: Informational Intervention Other: Survey Administration Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Facebook Intervention for Young Onset Melanoma Patients and Families
Actual Study Start Date : September 1, 2019
Estimated Primary Completion Date : June 1, 2023
Estimated Study Completion Date : June 1, 2023


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: Informational Intervention
Receive information focusing on skin cancer

Other: Survey Administration
Ancillary studies

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: Informational Intervention
Receive information on healthy lifestyle

Other: Survey Administration
Ancillary studies




Primary Outcome Measures :
  1. Total cutaneous examination (TCE) [ Time Frame: At 6 months ]
    Will be assessed as a binary response (yes/no) did participant have one


Secondary Outcome Measures :
  1. Skin Self-exam (Relatives) [ Time Frame: Up to 5 years ]
    Skin self-exam of first degree relatives will be analyzed as a binary (yes/no) Response did participant complete one Yes/No

  2. Skin self-exam - Count Response (Relatives) [ Time Frame: Up to 5 years ]
    Skin self exam of first degree relatives count response will be calculated as frequency/month. Frequency per month reported as a number.

  3. Skin self-exam - Comprehensiveness (Relatives) [ Time Frame: Up to 5 years ]
    : Skin self-exam of first degree relatives comprehensiveness calculated as total # body parts examined during the skin self-exam

  4. Sun Protection Habits (Relatives) [ Time Frame: Up to 5 years ]
    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).

  5. Skin self-exam - Count Response (Patients) [ Time Frame: Up to 5 years ]
    Skin self-exam of patients count response calculated as (frequency/month). Frequency per month reported as a number

  6. Skin self-exam - Comprehensiveness (Patients) [ Time Frame: Up to 5 years ]
    Skin self-exam of patients comprehensiveness calculated as total # body parts examined during the skin self-exam.

  7. Sun Protection Habits (Patients) [ Time Frame: Up to 5 years ]
    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).


Other Outcome Measures:
  1. Mediator analyses - Intervention Group [ Time Frame: 6 months ]
    Mediator analyses examining normative influences on the effects of intervention group on TCE, SSE and sun protection.

  2. Mediator analyses - (Relatives) [ Time Frame: 6 months ]
    Mediator analyses examining family and peer support and discussion on the effects of intervention group on TCE, SSE and sun protection.

  3. Mediator analyses - Intervention Group - Risks [ Time Frame: 6 months ]
    Mediator analyses examining risk on the effects of intervention group on TCE, SSE and sun protection.

  4. Mediator analyses - Intervention Group - Benefits [ Time Frame: 6 months ]
    Mediator analyses examining benefits on the effects of intervention group on TCE, SSE and sun protection.

  5. Mediator analyses - Intervention Group - Barriers [ Time Frame: 6 months ]
    Mediator analyses examining barriers on the effects of intervention group on TCE, SSE and sun protection.

  6. Mediator analyses - Intervention Group - Self-efficacy [ Time Frame: 6 months ]
    Mediator analyses examining self-efficacy on the effects of intervention group on TCE, SSE and sun protection.

  7. Mediator analyses - Intervention Group - Change Strategies [ Time Frame: 6 months ]
    Mediator analyses examining use of change strategies on the effects of intervention group on TCE, SSE and sun protection.

  8. Moderator analysis - Melanoma Risk Factors [ Time Frame: 6 months ]
    Moderator analysis Melanoma risk factors will explore whether the intervention group is more effective for subsets of FDRs.

  9. Moderator analysis - month of the year enrolled [ Time Frame: 6 months ]
    Moderator analysis month of the year enrolled will explore whether the intervention group is more effective for subsets of FDRs.

  10. Moderator analysis - Residential Latitude [ Time Frame: 6 months ]
    Moderator analysis residential latitude will explore whether the intervention group is more effective for subsets of FDRs.

  11. Moderator analysis - Sex [ Time Frame: 6 months ]
    Moderator analysis sex will explore whether the intervention group is more effective for subsets of FDRs.

  12. Moderator analysis - patient disease stage [ Time Frame: 6 months ]
    Moderator analysis patient disease stage will explore whether the intervention group is more effective for subsets of FDRs.

  13. Moderator analysis relationship to patient [ Time Frame: 6 months ]
    Moderator analysis relationship to patient will explore whether the intervention group is more effective for subsets of FDRs.

  14. Predictor - Engagement [ Time Frame: 6 months ]
    Facebook engagement including likes, comments- collected at the end of the group

  15. Predictor - Social Network Use [ Time Frame: 6 months ]
    Social network use measured by self-reported frequency of use of popular social media sites



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03677739


Locations
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United States, New Jersey
Rutgers Cancer Institute of New Jersey Recruiting
New Brunswick, New Jersey, United States, 08903
Contact: Sharon Manne    732-235-6759    mannesl@cinj.rutgers.edu   
Principal Investigator: Sharon Manne         
Sponsors and Collaborators
Rutgers, The State University of New Jersey
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Sharon Manne Rutgers Cancer Institute of New Jersey

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Responsible Party: Sharon Manne, PhD, Professor of Medicine, Rutgers Cancer Institute of New Jersey
ClinicalTrials.gov Identifier: NCT03677739     History of Changes
Other Study ID Numbers: 131812
NCI-2018-01741 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
Pro2018001697
131812 ( Other Identifier: Rutgers Cancer Institute of New Jersey )
P30CA072720 ( U.S. NIH Grant/Contract )
R01CA221854 ( U.S. NIH Grant/Contract )
First Posted: September 19, 2018    Key Record Dates
Last Update Posted: September 17, 2019
Last Verified: September 2019

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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
Additional relevant MeSH terms:
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Melanoma
Skin Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Neoplasms by Site
Skin Diseases