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Family Lifestyle Actions and Risk Education Study (FLARE)

Primary Purpose

Melanoma, Child

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

FLARE

About this trial

This is an interventional prevention trial for Melanoma focused on measuring Education, Prevention and Control, Behavioral Research

Eligibility Criteria

8 Years - 110 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Huntsman Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

FLARE intervention

Arm Description

All FLARE participants enrolled will receive the intervention

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

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

Skin Self-exam Occurrence Assessed Via Questionnaire

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

Skin Self-exam Occurrence Assessed Via Diary

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

Sunburn Occurrence Assessed Via Diary

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

Sunburn Occurrence Assessed Via Questionnaire

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

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)

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

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).

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

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

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)

Full Information

NCT ID

NCT02846714

First Posted

July 17, 2016

Last Updated

April 16, 2019

Sponsor

University of Utah

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT02846714

Brief Title

Family Lifestyle Actions and Risk Education Study

Acronym

FLARE

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2019

Overall Recruitment Status

Completed

Study Start Date

July 2016 (undefined)

Primary Completion Date

November 2017 (Actual)

Study Completion Date

November 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Utah

Collaborators

National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

Detailed 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).

6. Conditions and Keywords

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

Melanoma, Child

Keywords

Education, Prevention and Control, Behavioral Research

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

42 (Actual)

8. Arms, Groups, and Interventions

Arm Title

FLARE intervention

Arm Type

Experimental

Arm Description

All FLARE participants enrolled will receive the intervention

Intervention Type

Behavioral

Intervention Name(s)

FLARE

Primary Outcome Measure Information:

Title

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

Description

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.

Time Frame

Week 9 (post-intervention)

Secondary Outcome Measure Information:

Title

Photoprotective Behaviors Assessed With the Sun Habits Survey

Description

Time Frame

Weeks 1 (baseline), 3,5,7,9,13

Title

Photoprotective Behaviors Assessed With the PALE Questionnaire

Description

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

Time Frame

Weeks 1 (baseline), 3,5,7,9,13

Title

Skin Self-exam Occurrence Assessed Via Questionnaire

Description

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

Time Frame

Weeks 1 (baseline), 3,5,7,9,13

Title

Skin Self-exam Occurrence Assessed Via Diary

Description

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

Time Frame

Weeks 1 (baseline), 3,5,7,9,13

Title

Sunburn Occurrence Assessed Via Diary

Description

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

Time Frame

Weeks 1 (baseline), 3,5,7,9,13

Title

Sunburn Occurrence Assessed Via Questionnaire

Description

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

Time Frame

Weeks 1 (baseline), 3,5,7,9,13

Title

Ultraviolet Radiation (UVR) Exposure Assessed Via Dosimeter Device

Description

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)

Time Frame

Weeks 1 (baseline),9,13

Title

Ultraviolet Radiation (UVR) Exposure Assessed Via PALE Questionnaire

Description

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

Time Frame

Weeks 1 (baseline), 3,5,7,9,13

Title

Degree of Tan on Skin Assessed Via Reflectance Spectroscopy

Description

Time Frame

Weeks 1 (baseline),9,13

Title

Photoprotection Behavior Changes Assessed Via Questionnaire

Description

Time Frame

Weeks 1,9,13

Title

Skin Self-exam Behavior Changes

Description

Time Frame

Weeks 1,9,13

Title

Acceptability of Intervention Assessed Via Questionnaire

Description

Time Frame

Week 9

10. Eligibility

Sex

All

Minimum Age & Unit of Time

8 Years

Maximum Age & Unit of Time

110 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yelena Wu, PhD

Organizational Affiliation

University of Utah

Official's Role

Principal Investigator

Facility Information:

Facility Name

Huntsman Cancer Institute

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84112

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

18283179

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.

Results Reference

background

PubMed Identifier

15193896

Citation

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. doi: 10.1016/j.ypmed.2004.01.020.

Results Reference

background

PubMed Identifier

14675857

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. doi: 10.1016/s1388-9842(03)00158-2.

Results Reference

background

PubMed Identifier

22942273

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.

Results Reference

background

PubMed Identifier

25642574

Citation

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. Available from http://www.ncbi.nlm.nih.gov/books/NBK263782/

Results Reference

background

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.

Results Reference

background

PubMed Identifier

31520429

Citation

Wu YP, Boucher K, Hu N, Hay J, Kohlmann W, Aspinwall LG, Bowen DJ, Parsons BG, Nagelhout ES, Grossman D, Mooney K, Leachman SA, Tercyak KP. A pilot study of a telehealth family-focused melanoma preventive intervention for children with a family history of melanoma. Psychooncology. 2020 Jan;29(1):148-155. doi: 10.1002/pon.5232. Epub 2019 Nov 10.

Results Reference

derived

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Family Lifestyle Actions and Risk Education Study

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