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Completed

NCT Number: NCT02846714

Family Lifestyle Actions and Risk Education Study

The overall purpose of this study is to test the feasibility, acceptability, and preliminary efficacy of a family-focused behavioral intervention ("FLARE", which stands for Family Lifestyle Actions and Risk Education) that aims to improve adherence to melanoma preventive behaviors among children at elevated risk for the disease.

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Key information

Conditions

Melanoma Child Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

8 year–110 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

About this study

Test the feasibility and acceptability of FLARE, a family-focused behavioral intervention that is designed to improve and maintain adherence to photoprotection (e.g., use of sunscreen) and screening (e.g., implementation of self skin exams). We expect that the feasibility of the intervention will be supported by at least 75% of participants attending at least 3 intervention sessions. We also expect that the acceptability of the intervention (e.g., overall satisfaction, ease of participation, perceived utility of intervention) will be supported by mean ratings that indicate adequate levels of acceptability across participants (e.g., mean rating of "satisfied" or "very satisfied" for overall satisfaction).

Pilot test the efficacy of the FLARE intervention with children at elevated risk for melanoma and their primary caregiver.

We will also explore the potential impact of the FLARE intervention on melanoma preventive behaviors among siblings of the child who receives the intervention, as well as the child's other parent/caregiver (if another parent/caregiver is available).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Children

  • Are 8-17 years old AND
  • Are at risk for melanoma due to having a first degree relative with a history of melanoma and/or at least 3 second or third degree relatives on the same side of the family with a history of melanoma AND/OR
  • Have personally received genetic testing for the CDKN2A/p16 genetic mutation and/or has one or more family members who received CDKN2A/p16 testing

Adults

  • Are at least 18 years old AND
  • Are the primary caregiver for the child participating in the study (defined as the individual who is responsible for daily implementation of health-related tasks for the child) AND
  • Have at least one child under age 18 who is living in the same household AND
  • Have a personal history of melanoma and/or family history of melanoma) AND/OR
  • Have personally received genetic testing for the CDKN2A/p16 genetic mutation and/or has one or more family members who received CDKN2A/p16 testing

Exclusion criteria

  • Individuals who do not speak, read/write English will be excluded because FLARE involves regular interaction between study staff and research participants in English and completion of study questionnaires and interviews in English

Treatment and study plan

FLARE

Behavioral

Primary outcomes

  1. Percent of Participants Retained Throughout Intervention as Assessed by Session Attendance Recorded by Interventionist

    Time frame: Week 9 (post-intervention)

    Session attendance will be recorded by the interventionist at each scheduled session. The percent of participants who are retained throughout the 3 session intervention will be calculated.

Secondary outcomes

  1. Photoprotective Behaviors Assessed With the Sun Habits Survey

    Time frame: Weeks 1 (baseline), 3,5,7,9,13

    "These next questions ask about what you have done in the past month if you were outdoors in the sun for 15 minutes or more. How often did you..." Minimum value = 1; Maximum value = 5; Higher scores indicate a better outcome

  2. Photoprotective Behaviors Assessed With the PALE Questionnaire

    Time frame: Weeks 1 (baseline), 3,5,7,9,13

    Protection-Adjusted Length of Exposure Index (PALE) Assesses photoprotective behavior during reported activities to yield daily minutes of unprotected sun exposure during each time frame

  3. Skin Self-exam Occurrence Assessed Via Questionnaire

    Time frame: Weeks 1 (baseline), 3,5,7,9,13

    Number of participants who received a skin self-exam during each time frame

  4. Skin Self-exam Occurrence Assessed Via Diary

    Time frame: Weeks 1 (baseline), 3,5,7,9,13

    Number of participants who received a skin self-exam during each time frame interval

  5. Sunburn Occurrence Assessed Via Diary

    Time frame: Weeks 1 (baseline), 3,5,7,9,13

    Number of participants who got a sunburn during each time frame interval

  6. Sunburn Occurrence Assessed Via Questionnaire

    Time frame: Weeks 1 (baseline), 3,5,7,9,13

    Number of participants who received a sunburn during each time frame.

  7. Ultraviolet Radiation (UVR) Exposure Assessed Via Dosimeter Device

    Time frame: Weeks 1 (baseline),9,13

    Change of weekly average UV intake from Week 1 (baseline) to Week 9 (post-intervention) and from Week 9 to Week 13 (1-month follow up)

  8. Ultraviolet Radiation (UVR) Exposure Assessed Via PALE Questionnaire

    Time frame: Weeks 1 (baseline), 3,5,7,9,13

    Protection-Adjusted Length of Exposure Index (PALE) Assesses UVR exposure during reported activities to yield daily minutes of unprotected sun exposure during each time frame

  9. Degree of Tan on Skin Assessed Via Reflectance Spectroscopy

    Time frame: Weeks 1 (baseline),9,13

    Mean degree of tan on skin assessed via reflectance spectroscopy of 4 different body parts (exposed wrist, outer arm, chin, and face) at each time frame. Measurements were taken using a spectrophotometer to quantify skin color. Melanin index values were recorded, with a higher value representing more melanin in the skin (i.e., darker skin).

  10. Photoprotection Behavior Changes Assessed Via Questionnaire

    Time frame: Weeks 1,9,13

    Mean difference for each photoprotection behavior from Week 1 (pre-intervention) to Week 9 (post-intervention) and from Week 9 to Week 13 (1 month follow-up).

    "These next questions ask about what you have done in the past month if you were outdoors in the sun for 15 minutes or more. How often did you..." Minimum value = 1; Maximum value = 5; A higher mean difference indicates a better outcome

  11. Skin Self-exam Behavior Changes

    Time frame: Weeks 1,9,13

    Mean difference for frequency of skin self-exam and thoroughness of skin self-exam (measured by number of body parts examined) from Week 1 (pre-intervention) to Week 9 (post-intervention) and from Week 9 to Week 13 (1 month follow-up). (SSE = skin self-exam)

    Change in frequency of SSE: "In the past month, how often did you check your skin for any new or changed moles or growths?" 1 = SSE less than once a month, 2 = SSE once a month, 3 = SSE more than once a month; higher mean difference indicates a better outcome.

    Change in thoroughness of SSE: "In the past month, which of the body parts listed below were checked for any new or changed moles or growths" Minimum value = 0 (checked 0 body parts during SSE); Maximum value = 15 (checked 15 body parts during SSE); higher mean difference indicates a better outcome

  12. Acceptability of Intervention Assessed Via Questionnaire

    Time frame: Week 9

    "In these next 15 questions, we want to learn more about your thoughts about what you learned through the FLARE sessions you've had with us in-person and via WebEx or phone. Please indicate how much you agree with each statement." 15 total constructs summed, each was on the same 5 point Likert scale (1 = Strongly Disagree, 5 = Strongly Agree).

    Minimum value = 1; Maximum Value = 75; higher score means a better outcome (better acceptability)

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

FLARE: Family Lifestyle Actions and Risk Education Study for Children With a Familial Risk for Melanoma

Acronym: FLARE

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jul 27, 2016
Registry last updated
May 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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