Family Lifestyle Actions and Risk Education Study

NCT02846714 | Completed Results

• 2 other identifiers: IRB_00090292K07CA196985
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Melanoma; Child

Keywords

Education; Prevention and Control; Behavioral Research

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Photoprotective Behaviors Assessed With the Sun Habits Survey

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

• Photoprotective Behaviors Assessed With the PALE Questionnaire

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

• Skin Self-exam Occurrence Assessed Via Questionnaire

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

• Skin Self-exam Occurrence Assessed Via Diary

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

• Sunburn Occurrence Assessed Via Diary

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

Study Arms (1)

FLARE intervention

EXPERIMENTAL

All FLARE participants enrolled will receive the intervention

Behavioral: FLARE

Interventions

FLARE BEHAVIORAL

FLARE intervention

Eligibility Criteria

• Age: 8 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Utah: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

Related Publications (7)

• 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.

  PMID: 18283179 BACKGROUND

• 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.

  PMID: 15193896 BACKGROUND

• 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.

  PMID: 14675857 BACKGROUND

• 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.

  PMID: 22942273 BACKGROUND

• 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/

  PMID: 25642574 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 31520429 DERIVED

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Yelena Wu
• Organization: Huntsman Cancer Institute University of Utah

yelena.wu@utah.edu

8012135653

Study Officials

• Yelena Wu, PhD

  University of Utah

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Investigator

Study Record Dates

• First Submitted: July 17, 2016
• First Posted: July 27, 2016
• Study Start: July 1, 2016
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: May 8, 2019
• Results First Posted: May 8, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)