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Tailored Intervention for Melanoma Patient's Families


N/A
21 Years
N/A
Not Enrolling
Both
Melanoma

Thank you

Trial Information

Tailored Intervention for Melanoma Patient's Families


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.

Inclusion Criteria


Inclusion Criteria - Patients (for referral of FDRs):

- 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

Inclusion Criteria - FDR (First Degree Relative):

- 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 - FDR:

- 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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Impact of generic print and phone counseling vs. tailored print and phone counseling interventions on the engagement in total cutaneous examination (TCE) and self-skin examination (SSE) among first degree relatives (FDRs) at increased risk for CMM.

Outcome Time Frame:

approximately 9 months per participant

Safety Issue:

No

Principal Investigator

Paul Jacobsen, Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

H. Lee Moffitt Cancer Center and Research Institute

Authority:

United States: Institutional Review Board

Study ID:

FCCC- 05-805

NCT ID:

NCT00816374

Start Date:

August 2005

Completion Date:

May 2011

Related Keywords:

  • Melanoma
  • cutaneous malignant melanoma
  • CMM
  • total cutaneous examination
  • TCE
  • skin self-examination
  • SSE
  • first degree relatives
  • FDR
  • skin cancer protection
  • skin cancer screening
  • Melanoma

Name

Location

Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
University of PennsylvaniaPhiladelphia, Pennsylvania  19104
H. Lee Moffitt Cancer Center & Research InstituteTampa, Florida  33612