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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

Primary Purpose

Clinical Stage 0 Cutaneous Melanoma AJCC v8, Clinical Stage I Cutaneous Melanoma AJCC v8, Clinical Stage IA Cutaneous Melanoma AJCC v8

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Informational Intervention
Informational Intervention
Survey Administration
Sponsored by
Rutgers, The State University of New Jersey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Clinical Stage 0 Cutaneous Melanoma AJCC v8

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Rutgers Cancer Institute of New JerseyRecruiting
  • MD Anderson Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Arm 1 Young melanoma Family Facebook focusing on skin cancer

Arm 2 Healthy Lifestyle Facebook focusing on healthy lifestyle

Arm Description

Participants join a secret Young melanoma Family Facebook Group and view post messages focusing on skin cancer for 12 weeks.

Participants join a secret Healthy Lifestyle Facebook Group and view post messages focusing on healthy lifestyle for 12 weeks.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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.
Skin self-exam - Comprehensiveness (Relatives)
: Skin self-exam of first degree relatives comprehensiveness calculated as total # body parts examined during the skin self-exam
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).
Skin self-exam - Count Response (Patients)
Skin self-exam of patients count response calculated as (frequency/month). Frequency per month reported as a number
Skin self-exam - Comprehensiveness (Patients)
Skin self-exam of patients comprehensiveness calculated as total # body parts examined during the skin self-exam.
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).

Full Information

First Posted
August 24, 2018
Last Updated
February 6, 2023
Sponsor
Rutgers, The State University of New Jersey
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT03677739
Brief Title
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

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 3, 2019 (Actual)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rutgers, The State University of New Jersey
Collaborators
National Cancer Institute (NCI)

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm 1 Young melanoma Family Facebook focusing on skin cancer
Arm Type
Experimental
Arm Description
Participants join a secret Young melanoma Family Facebook Group and view post messages focusing on skin cancer for 12 weeks.
Arm Title
Arm 2 Healthy Lifestyle Facebook focusing on healthy lifestyle
Arm Type
Experimental
Arm Description
Participants join a secret Healthy Lifestyle Facebook Group and view post messages focusing on healthy lifestyle for 12 weeks.
Intervention Type
Other
Intervention Name(s)
Informational Intervention
Intervention Description
Receive information focusing on skin cancer
Intervention Type
Other
Intervention Name(s)
Informational Intervention
Intervention Description
Receive information on healthy lifestyle
Intervention Type
Other
Intervention Name(s)
Survey Administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Total cutaneous examination (TCE)
Description
Will be assessed as a binary response (yes/no) did participant have one
Time Frame
At 6 months
Secondary Outcome Measure Information:
Title
Skin Self-exam (Relatives)
Description
Skin self-exam of first degree relatives will be analyzed as a binary (yes/no) Response did participant complete one Yes/No
Time Frame
Up to 5 years
Title
Skin self-exam - Count Response (Relatives)
Description
Skin self exam of first degree relatives count response will be calculated as frequency/month. Frequency per month reported as a number.
Time Frame
Up to 5 years
Title
Skin self-exam - Comprehensiveness (Relatives)
Description
: Skin self-exam of first degree relatives comprehensiveness calculated as total # body parts examined during the skin self-exam
Time Frame
Up to 5 years
Title
Sun Protection Habits (Relatives)
Description
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).
Time Frame
Up to 5 years
Title
Skin self-exam - Count Response (Patients)
Description
Skin self-exam of patients count response calculated as (frequency/month). Frequency per month reported as a number
Time Frame
Up to 5 years
Title
Skin self-exam - Comprehensiveness (Patients)
Description
Skin self-exam of patients comprehensiveness calculated as total # body parts examined during the skin self-exam.
Time Frame
Up to 5 years
Title
Sun Protection Habits (Patients)
Description
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).
Time Frame
Up to 5 years
Other Pre-specified Outcome Measures:
Title
Mediator analyses - Intervention Group
Description
Mediator analyses examining normative influences on the effects of intervention group on TCE, SSE and sun protection.
Time Frame
6 months
Title
Mediator analyses - (Relatives)
Description
Mediator analyses examining family and peer support and discussion on the effects of intervention group on TCE, SSE and sun protection.
Time Frame
6 months
Title
Mediator analyses - Intervention Group - Risks
Description
Mediator analyses examining risk on the effects of intervention group on TCE, SSE and sun protection.
Time Frame
6 months
Title
Mediator analyses - Intervention Group - Benefits
Description
Mediator analyses examining benefits on the effects of intervention group on TCE, SSE and sun protection.
Time Frame
6 months
Title
Mediator analyses - Intervention Group - Barriers
Description
Mediator analyses examining barriers on the effects of intervention group on TCE, SSE and sun protection.
Time Frame
6 months
Title
Mediator analyses - Intervention Group - Self-efficacy
Description
Mediator analyses examining self-efficacy on the effects of intervention group on TCE, SSE and sun protection.
Time Frame
6 months
Title
Mediator analyses - Intervention Group - Change Strategies
Description
Mediator analyses examining use of change strategies on the effects of intervention group on TCE, SSE and sun protection.
Time Frame
6 months
Title
Moderator analysis - Melanoma Risk Factors
Description
Moderator analysis Melanoma risk factors will explore whether the intervention group is more effective for subsets of FDRs.
Time Frame
6 months
Title
Moderator analysis - month of the year enrolled
Description
Moderator analysis month of the year enrolled will explore whether the intervention group is more effective for subsets of FDRs.
Time Frame
6 months
Title
Moderator analysis - Residential Latitude
Description
Moderator analysis residential latitude will explore whether the intervention group is more effective for subsets of FDRs.
Time Frame
6 months
Title
Moderator analysis - Sex
Description
Moderator analysis sex will explore whether the intervention group is more effective for subsets of FDRs.
Time Frame
6 months
Title
Moderator analysis - patient disease stage
Description
Moderator analysis patient disease stage will explore whether the intervention group is more effective for subsets of FDRs.
Time Frame
6 months
Title
Moderator analysis relationship to patient
Description
Moderator analysis relationship to patient will explore whether the intervention group is more effective for subsets of FDRs.
Time Frame
6 months
Title
Predictor - Engagement
Description
Facebook engagement including likes, comments- collected at the end of the group
Time Frame
6 months
Title
Predictor - Social Network Use
Description
Social network use measured by self-reported frequency of use of popular social media sites
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sharon Manne
Organizational Affiliation
Rutgers Cancer Institute of New Jersey
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rutgers Cancer Institute of New Jersey
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sharon Manne
Phone
732-235-6759
Email
mannesl@cinj.rutgers.edu
First Name & Middle Initial & Last Name & Degree
Sharon Manne
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Susan Peterson, PhD
Phone
713-792-8267
Email
speterso@mdanderson.org

12. IPD Sharing Statement

Learn more about this trial

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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