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A Feasibility Study of an Online Intervention for Sexual Rehabilitation in Prostate Cancer

13 de marzo de 2014 actualizado por: Nova Scotia Health Authority

Background: Prostate cancer (PCa) is the most common cancer for men. When treated early enough it is typically curable. However, common treatments, such as radical prostatectomy and radiation therapy, often result in significant negative outcomes with regard to sexual, psychological and social function. Both men and partners have identified the need for more information and support to address sexual health concerns after treatment. However, very few sexual rehabilitation interventions have been developed and rigorously assessed.

Purpose: The investigators propose to develop and pilot test a new program to meet the sexual health needs of men with PCa and their partners using an online, professionally facilitated education/support program. The goals of the program are to improve sexual function, intimacy and mood for men and their partners after treatment for localized PCa. The program will be offered through Cancer Chat Canada, an existing and well-tested Canadian platform for professionally facilitated support group programs.

What Participants Can Expect: A total of 24 men and their female partners (48 individuals) will be recruited and assigned to one of two groups. The first group will participate in the program immediately; the second group will be offered the program after a 5-month delay. The decision about which group will start immediately and which later will be made randomly (by chance). Both groups of men and partners will be asked to complete questionnaires three times and, at the end of the program, to provide the researchers feedback about how satisfied they were with the program, the changes they made, things they learned as a result of the program, and suggestions for improving the program. Participants must have access to a computer, an Internet connection and be willing to attend online, chat room meetings each week for 1.5 hours for 6 weeks.

Implications: Sexual rehabilitation is a high need for men affected by PCa, but is difficult to access. The investigators hope to improve access to sexual health care through this study.

Descripción general del estudio

Estado

Desconocido

Condiciones

Tipo de estudio

Intervencionista

Inscripción (Anticipado)

48

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

    • Nova Scotia
      • Halifax, Nova Scotia, Canadá
        • Reclutamiento
        • Capital District
        • Contacto:
        • Investigador principal:
          • Deborah L McLeod, R.N., Ph.D.

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

  • Niño
  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Men who have been treated for localized prostate cancer
  • AND men must be 6-36 months post-prostatectomy or radiation (as primary treatment) of prostate cancer
  • Must have a heterosexual, co-cohabiting partner who is willing to participate
  • Must speak and read English
  • Must be able to use a computer and have internet access

Exclusion Criteria:

  • Homosexual couples will not be included in this study
  • Major self-reported psychiatric illness
  • Couples who screen below 30 on the DAS (Dyadic Adjustment Scale)

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 de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Couples Prostate Cancer Support Group

The participants in the support group will receive 6 weekly online intervention sessions with a professional facilitator. In addition participants will be asked to complete relationship-enhancement exercises and readings in between sessions.

Participants will be asked to complete questionnaires at three time points: 1)pre-intervention (baseline) 2) post-intervention (7 weeks), and 3) post intervention (13 weeks).

The participants in the experimental group will receive 6 weekly online intervention sessions with a professional facilitator. In addition participants will be asked to complete relationship-enhancement exercises and readings in between sessions.

In the experimental group, participants will be asked to complete questionnaires at three time points: 1)pre-intervention (baseline) 2) post-intervention (7 weeks), and 3) post intervention (13 weeks).

In the waitlist group, participants will not participate in the support group. Participants will be asked to complete questionnaires at three time points: 1)pre-intervention (baseline) 2) post-intervention (7 weeks), and 3) post intervention (13 weeks).

Sin intervención: Wait-List Control
Participants will be asked to complete questionnaires at three time points: 1)week 1 2) week 7, and 3) week 13.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Periodo de tiempo
Change in Sexual Function from Baseline to 13 weeks
Periodo de tiempo: Pre-Intervention (Week 1); Post-Intervention (Week 7); 3 Months Post-Intervention (Week 13)
Pre-Intervention (Week 1); Post-Intervention (Week 7); 3 Months Post-Intervention (Week 13)

Medidas de resultado secundarias

Medida de resultado
Periodo de tiempo
Change in Personal Assessment of Intimacy and Relationships from baseline to 13 weeks
Periodo de tiempo: Pre-Intervention (Week 1); Post-Intervention (Week 7); 3 Months Post-Intervention (Week 13)
Pre-Intervention (Week 1); Post-Intervention (Week 7); 3 Months Post-Intervention (Week 13)

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Profile of Mood States Short Form from baseline to 13 weeks
Periodo de tiempo: Pre-Intervention (Week 1); Post-Intervention (Week 7); 3 Months Post-Intervention (Week 13)
This tool assesses psychological distress across 6 domains: fatigue-inertia, vigor-activity, tension-anxiety, depression-dejection, anger-hostility, and confusion-bewilderment.
Pre-Intervention (Week 1); Post-Intervention (Week 7); 3 Months Post-Intervention (Week 13)

Colaboradores e Investigadores

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

Investigadores

  • Investigador principal: Deborah L McLeod, R.N., Ph.D., Capital District Health Authority & Dalhousie University
  • Investigador principal: Richard J Wassersug, Ph.D., University of British Columbia
  • Investigador principal: Karen Fergus, Ph.D., C. Psych., Sunnybrook Odette Cancer Centre & York University
  • Investigador principal: John Robinson, Ph.D., C. Psych., Tom Baker Cancer Centre & University of Calgary
  • Investigador principal: John Oliffe, R.N, Ph.D., University of British Columbia

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 noviembre de 2012

Finalización primaria (Anticipado)

1 de diciembre de 2014

Finalización del estudio (Anticipado)

1 de diciembre de 2014

Fechas de registro del estudio

Enviado por primera vez

16 de octubre de 2012

Primero enviado que cumplió con los criterios de control de calidad

26 de octubre de 2012

Publicado por primera vez (Estimar)

30 de octubre de 2012

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

14 de marzo de 2014

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

13 de marzo de 2014

Última verificación

1 de marzo de 2014

Más información

Términos relacionados con este estudio

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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