Tailored Intervention for Melanoma Patient's Families

NCT ID: NCT00816374

Last Updated: 2014-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

553 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-08-31

Study Completion Date

2011-05-31

Brief Summary

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The purpose of the investigators' study is to find the best way to provide information about sun protection and skin cancer detection. The investigators want to see which of two methods most improves sun protection and screening attitudes and practices. The investigators hope to improve these attitudes and practices among people who are at higher risk for melanoma. People at higher risk for melanoma are first degree relatives (mother, father, sibling or child) of people diagnosed with melanoma.

Detailed Description

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Eligible patients will be contacted to find out whether they have any living first degree relatives that we may contact to discuss their participation in our study.

Eligible first degree relatives (FDRs) will participate in our study as outlined under Interventions.

Conditions

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Melanoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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1

Group I

Group Type OTHER

Reading materials and discussions

Intervention Type OTHER

We will send 3 sets of materials via mail, containing information about melanoma prevention and detection, 1 set each month for 3 months. Materials published by:

* The American Cancer Society
* The American Academy of Dermatology
* The Skin Cancer Foundation

The pamphlets contain information about ways to reduce risk for skin cancer including:

* Sun protection practices
* Risk factors for melanoma
* Information about what melanoma looks like
* How to do skin self-examinations

There will also be a telephone discussion with a health educator, discussing melanoma and other information contained in the pamphlets.

Questionnaires

Intervention Type OTHER

Both groups will complete 3 surveys; at the beginning, 3 months later, 6 months after the second survey. Each survey will ask about:

* knowledge of melanoma
* current and past skin cancer screening practices
* current and past sun protection practices
* attitudes about skin cancer and sun protection
* feelings about relative's melanoma diagnosis and treatment

2

Group II

Group Type OTHER

Reading materials and discussions

Intervention Type OTHER

We will send 3 separate pamphlets created specifically for participants. We will send 1 pamphlet each month for 3 months. The information in the pamphlets will be based on answers from the first survey. These pamphlets will contain information about:

* Melanoma and skin cancer protection guidelines
* The benefits of skin screening practices
* Ways to protect yourself from the sun

In addition to these pamphlets, there will be a telephone discussion with a health educator to discuss melanoma and other information contained in the pamphlets.

Questionnaires

Intervention Type OTHER

Both groups will complete 3 surveys; at the beginning, 3 months later, 6 months after the second survey. Each survey will ask about:

* knowledge of melanoma
* current and past skin cancer screening practices
* current and past sun protection practices
* attitudes about skin cancer and sun protection
* feelings about relative's melanoma diagnosis and treatment

Interventions

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Reading materials and discussions

We will send 3 sets of materials via mail, containing information about melanoma prevention and detection, 1 set each month for 3 months. Materials published by:

* The American Cancer Society
* The American Academy of Dermatology
* The Skin Cancer Foundation

The pamphlets contain information about ways to reduce risk for skin cancer including:

* Sun protection practices
* Risk factors for melanoma
* Information about what melanoma looks like
* How to do skin self-examinations

There will also be a telephone discussion with a health educator, discussing melanoma and other information contained in the pamphlets.

Intervention Type OTHER

Reading materials and discussions

We will send 3 separate pamphlets created specifically for participants. We will send 1 pamphlet each month for 3 months. The information in the pamphlets will be based on answers from the first survey. These pamphlets will contain information about:

* Melanoma and skin cancer protection guidelines
* The benefits of skin screening practices
* Ways to protect yourself from the sun

In addition to these pamphlets, there will be a telephone discussion with a health educator to discuss melanoma and other information contained in the pamphlets.

Intervention Type OTHER

Questionnaires

Both groups will complete 3 surveys; at the beginning, 3 months later, 6 months after the second survey. Each survey will ask about:

* knowledge of melanoma
* current and past skin cancer screening practices
* current and past sun protection practices
* attitudes about skin cancer and sun protection
* feelings about relative's melanoma diagnosis and treatment

Intervention Type OTHER

Other Intervention Names

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Supportive Care Intervention Behavioral Supportive Care Intervention Behavioral Supportive Care Intervention Behavioral

Eligibility Criteria

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Inclusion Criteria

* Newly diagnosed with cutaneous malignant melanoma (CMM) within the past 2 years but more than 3 months prior to being approached
* Seen at FCCC, FCCC Network, Temple, MCC, or HUP patient clinics
* Greater than 18 years of age
* English speaking
* Able to give meaningful informed consent
* Does NOT have a first-degree relative with CMM


* Current age of at least 21 years
* One or more of the following additional risk factors; blonde or red hair; marked freckling on the upper back; history of 3 or more blistering sunburns prior to age 20; 3 or more years of an outdoor summer job as a teenager; Actinic keratosis
* Able to give informed consent
* English speaking
* Has residential phone service
* No personal history of CMM or non-melanoma skin cancer
* No personal history of dysplastic nevi

Exclusion Criteria

* 2 or more first degree relatives with CMM
* Has had a total cutaneous examination (TCE) in the past 3 years AND has done skin self-examination (SSE) more than once in the past year AND has a sun protection habits mean score greater than or equal to 4 (often). We are selecting a set participants who are NOT compliant with TCE and are inconsistent/minimal performers of SSE and sun protection practices.
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Fox Chase Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Paul Jacobsen, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

H. Lee Moffitt Cancer Center and Research Institute

Sharon L Manne, PhD

Role: PRINCIPAL_INVESTIGATOR

Fox Chase Cancer Center

Michael Ming, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

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H. Lee Moffitt Cancer Center & Research Institute

Tampa, Florida, United States

Site Status

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

References

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Coups EJ, Manne SL, Jacobsen PB, Ming ME, Heckman CJ, Lessin SR. Skin surveillance intentions among family members of patients with melanoma. BMC Public Health. 2011 Nov 14;11:866. doi: 10.1186/1471-2458-11-866.

Reference Type BACKGROUND
PMID: 22082038 (View on PubMed)

Manne S, Jacobsen PB, Ming ME, Winkel G, Dessureault S, Lessin SR. Tailored versus generic interventions for skin cancer risk reduction for family members of melanoma patients. Health Psychol. 2010 Nov;29(6):583-93. doi: 10.1037/a0021387.

Reference Type RESULT
PMID: 21090893 (View on PubMed)

Manne SL, Coups EJ, Jacobsen PB, Ming M, Heckman CJ, Lessin S. Sun protection and sunbathing practices among at-risk family members of patients with melanoma. BMC Public Health. 2011 Feb 21;11:122. doi: 10.1186/1471-2458-11-122.

Reference Type RESULT
PMID: 21338483 (View on PubMed)

Other Identifiers

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IRB 05-805

Identifier Type: -

Identifier Source: secondary_id

FCCC- 05-805

Identifier Type: -

Identifier Source: org_study_id

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