Family Lifestyle Actions and Risk Education Study

Melanoma Clinical Trial

— FLARE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02846714
• Other study ID #: IRB_00090292
• Secondary ID: K07CA196985
• Status: Completed
• Phase: N/A
• Start date: July 2016
• Est. completion date: November 2017

Study information

• Verified date: April 2019
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: November 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 110 Years

Eligibility

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

Related Conditions & MeSH terms

• Child
• Melanoma

Intervention

Behavioral:
• FLARE

Locations

Country	Name	City	State
United States	Huntsman Cancer Institute	Salt Lake City	Utah

Sponsors (2)

Lead Sponsor	Collaborator
University of Utah	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (6)

Gage H, Grainger L, Ting S, Williams P, Chorley C, Carey G, Borg N, Bryan K, Castleton B, Trend P, Kaye J, Jordan J, Wade D. Specialist rehabilitation for people with Parkinson’s disease in the community: a randomised controlled trial. Southampton (UK): NIHR Journals Library; 2014 Dec. — View Citation

Glanz K, Yaroch AL, Dancel M, Saraiya M, Crane LA, Buller DB, Manne S, O'Riordan DL, Heckman CJ, Hay J, Robinson JK. Measures of sun exposure and sun protection practices for behavioral and epidemiologic research. Arch Dermatol. 2008 Feb;144(2):217-22. doi: 10.1001/archdermatol.2007.46. — View Citation

Gwadry-Sridhar F, Guyatt GH, Arnold JM, Massel D, Brown J, Nadeau L, Lawrence S. Instruments to measure acceptability of information and acquisition of knowledge in patients with heart failure. Eur J Heart Fail. 2003 Dec;5(6):783-91. — View Citation

Kothe EJ, Mullan BA. Acceptability of a theory of planned behaviour email-based nutrition intervention. Health Promot Int. 2014 Mar;29(1):81-90. doi: 10.1093/heapro/das043. Epub 2012 Aug 31. — View Citation

Stump, T. K., Aspinwall, L. G., Taber, J. M., Edwards, R., & Leachman, S. A. Validation of the Protection-Adjusted Length of Exposure (PALE) Index - A New Self-Report Measure of UVR Exposure (2014, April). Paper presented at the annual meeting of the Society of Behavioral Medicine, Philadelphia, PA.

Weinstock MA, Risica PM, Martin RA, Rakowski W, Smith KJ, Berwick M, Goldstein MG, Upegui D, Lasater T. Reliability of assessment and circumstances of performance of thorough skin self-examination for the early detection of melanoma in the Check-It-Out Project. Prev Med. 2004 Jun;38(6):761-5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent of Participants Retained Throughout Intervention as Assessed by Session Attendance Recorded by Interventionist	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.	Week 9 (post-intervention)
Secondary	Photoprotective Behaviors Assessed With the Sun Habits Survey	"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	Weeks 1 (baseline), 3,5,7,9,13
Secondary	Photoprotective Behaviors Assessed With the PALE Questionnaire	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	Weeks 1 (baseline), 3,5,7,9,13
Secondary	Skin Self-exam Occurrence Assessed Via Questionnaire	Number of participants who received a skin self-exam during each time frame	Weeks 1 (baseline), 3,5,7,9,13
Secondary	Skin Self-exam Occurrence Assessed Via Diary	Number of participants who received a skin self-exam during each time frame interval	Weeks 1 (baseline), 3,5,7,9,13
Secondary	Sunburn Occurrence Assessed Via Diary	Number of participants who got a sunburn during each time frame interval	Weeks 1 (baseline), 3,5,7,9,13
Secondary	Sunburn Occurrence Assessed Via Questionnaire	Number of participants who received a sunburn during each time frame.	Weeks 1 (baseline), 3,5,7,9,13
Secondary	Ultraviolet Radiation (UVR) Exposure Assessed Via Dosimeter Device	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)	Weeks 1 (baseline),9,13
Secondary	Ultraviolet Radiation (UVR) Exposure Assessed Via PALE Questionnaire	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	Weeks 1 (baseline), 3,5,7,9,13
Secondary	Degree of Tan on Skin Assessed Via Reflectance Spectroscopy	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).	Weeks 1 (baseline),9,13
Secondary	Photoprotection Behavior Changes Assessed Via Questionnaire	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	Weeks 1,9,13
Secondary	Skin Self-exam Behavior Changes	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	Weeks 1,9,13
Secondary	Acceptability of Intervention Assessed Via Questionnaire	"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)	Week 9