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Tailored Intervention for Melanoma Patient's Families

15 de mayo de 2014 actualizado por: Fox Chase Cancer Center
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.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Actual)

553

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Estados Unidos
    • Florida
      • Tampa, Florida, Estados Unidos, 33612
        • H. Lee Moffitt Cancer Center & Research Institute
    • Pennsylvania
      • Philadelphia, Pennsylvania, Estados Unidos, 19104
        • UNIVERSITY of PENNSYLVANIA
      • Philadelphia, Pennsylvania, Estados Unidos, 19111-2497
        • Fox Chase Cancer Center

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

21 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Sí

Géneros elegibles para el estudio

Todos

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Cuidados de apoyo
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Otro: 1
Group I
Otro: 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.

Otros nombres:
  • Conductual
  • Supportive Care Intervention
Otro: 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.

Otros nombres:
  • Conductual
  • Supportive Care Intervention
Otro: 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
Otros nombres:
  • Conductual
  • Supportive Care Intervention
Otro: 2
Group II
Otro: 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.

Otros nombres:
  • Conductual
  • Supportive Care Intervention
Otro: 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.

Otros nombres:
  • Conductual
  • Supportive Care Intervention
Otro: 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
Otros nombres:
  • Conductual
  • Supportive Care Intervention

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Periodo de tiempo
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.
Periodo de tiempo: approximately 9 months per participant
approximately 9 months per participant

Medidas de resultado secundarias

Medida de resultado
Periodo de tiempo
Determine whether the interventions have an impact on attitudinal factors and whether these attitudinal factors mediate the expected association between the interventions and skin surveillance and sun exposure/protection.
Periodo de tiempo: approximately 9 months per participant
approximately 9 months per participant

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Fox Chase Cancer Center

Colaboradores

National Cancer Institute (NCI)

Investigadores

  • Investigador principal: Sharon L Manne, PhD, Fox Chase Cancer Center
  • Investigador principal: Paul Jacobsen, Ph.D., H. Lee Moffitt Cancer Center and Research Institute
  • Investigador principal: Michael Ming, MD, UNIVERSITY of PENNSYLVANIA

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Enlaces Útiles

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de agosto de 2005

Finalización primaria (Actual)

1 de mayo de 2011

Finalización del estudio (Actual)

1 de mayo de 2011

Fechas de registro del estudio

Enviado por primera vez

31 de diciembre de 2008

Primero enviado que cumplió con los criterios de control de calidad

31 de diciembre de 2008

Publicado por primera vez (Estimar)

1 de enero de 2009

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

16 de mayo de 2014

Última actualización enviada que cumplió con los criterios de control de calidad

15 de mayo de 2014

Última verificación

1 de mayo de 2014

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • FCCC- 05-805
  • IRB 05-805

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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