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MelanomaFLARENCT02846714

Family Lifestyle Actions and Risk Education Study

A study testing FLARE in people with Melanoma and Child, run by University of Utah at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 8 to 110 years
Conditions the study is for
Melanoma, Child
What is being tested?
FLARE
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
1 siteUnited States
Study dates
Jul 2016to Nov 2017
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 8 to 110 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Huntsman Cancer Institute

    Salt Lake City, Utah, 84112

Other trials in United States

About this study

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

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.

Read the 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).

Conditions
Melanoma, Child
Being tested
FLARE
Keywords
Education, Prevention and Control, Behavioral Research
Medical subject headings
Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FLAREBehavioural

Study groups in NCT02846714
Study groupRoleWhat they receive
FLARE interventionExperimentalAll FLARE participants enrolled will receive the intervention
Receives: Behavioral: FLARE

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Week 9 (post-intervention)

Secondary outcomes (12)

  1. 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

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

  2. 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

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

  3. Skin Self-exam Occurrence Assessed Via Questionnaire

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

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

  4. Skin Self-exam Occurrence Assessed Via Diary

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

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

  5. Sunburn Occurrence Assessed Via Diary

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

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

  6. Sunburn Occurrence Assessed Via Questionnaire

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

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

  7. 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)

    Measured: Weeks 1 (baseline),9,13

  8. 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

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

  9. 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).

    Measured: Weeks 1 (baseline),9,13

  10. 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

    Measured: Weeks 1,9,13

  11. 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

    Measured: Weeks 1,9,13

  12. 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)

    Measured: Week 9

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jul 2016 (estimated)
  2. Study startJul 2016
  3. Primary completionNov 2017
  4. Study completionNov 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02846714
Sponsor's protocol ID
IRB_00090292
Other IDs
K07CA196985
Acronym
FLARE
Status last verified
Apr 2019
First submitted
17 Jul 2016
Last updated
8 May 2019
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 18283179

  • 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.

    PubMed 15193896

  • 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.

    PubMed 14675857

  • 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.

    PubMed 22942273

  • 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/

    PubMed 25642574

  • 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.

  • 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.

    PubMed 31520429

Questions about this trial

What is this clinical trial studying?

A study testing FLARE in people with Melanoma and Child, run by University of Utah at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent of Participants Retained Throughout Intervention as Assessed by Session Attendance Recorded by Interventionist (time frame: Week 9 (post-intervention)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02846714, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2019.

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