- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03177759
Living With Prostate Cancer (LPC) (LPC)
Evaluating a Group Therapy Intervention to Alleviate Psychological Distress in Men With Prostate Cancer: An Assessment of a Group Therapy Program From Vancouver's Prostate Cancer Supportive Care (PCSC) Program
Descripción general del estudio
Estado
Condiciones
Descripción detallada
The Vancouver Prostate Centre's (VPCs) PCSC Program is designed to address the gap in supportive care for men with prostate cancer (PC), their partners and their families. The evaluation protocol described here is specific to the program called "Living with Prostate Cancer" (LPC) from the Psychooncology module of the PCSC Program. The specific rationale for this module is that many cancer patients will experience significant anxiety or depression at some point along their cancer journey. The module includes private, confidential clinic appointments for PC patients and their spouses/partners, either separately or together, with our registered clinical counsellor, to explore how to cope with difficult emotions such as fear, anxiety, sadness, helplessness, and other signs of emotional distress. The module is now being expanded to include small group discussions. LPC is a group therapy program in which men participate in a guided autobiographical life review through a process that focuses on developing a cohesive working group, learning strategic communication skills, and understanding and learning how to manage difficult emotions and transitional life stressors associated with PC. It also focuses on the processing and integrating of critical events that contribute to the men's present day identity and psychological function and involves the consolidation of the personal learning that occurs. It shifts the focus on transitioning into the future by developing specific individual, family and/or career goals that are reinforced by ongoing support from peers in the group. Finally, post-group referral plans are developed on an individual basis as needed.
The group therapy program includes men with a diagnosis of PC Stages 1 to 3. We will administer validated quantitative tools to assess depression and anxiety, general psychological functioning, and male role norms (masculinity) before, after, and at 3, 6, and 12-months following the program. The meeting 3 months after the program will include a focus group process.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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British Columbia
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Vancouver, British Columbia, Canadá, V5Z 1M9
- Vancouver Prostate Centre
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
Men are eligible to participate in this evaluation if they:
- are older than 18 years old
- are willing to attend the "Living with Prostate Cancer" group therapy sessions from the PCSC Program*
- are able to speak and read English such that they are able to understand the questionnaires
- have unimpaired cognitive function with an ability to understand the nature of the study
- are willing to complete questionnaires at 5 time points
provide written informed consent
- to be able to participate in LPC groups, men must have recently received a diagnosis of PC Stages 1 to 3, or have recently been recommended to undergo a form of treatment following a period of active surveillance.
Exclusion Criteria:
Men will be ineligible to participate in this evaluation if they:
- have difficulties reading or understanding English
- have psychotic symptoms, current severe alcohol or other drug dependence, unwillingness to refrain from substance use during the program, and/or significant cognitive impairment that would prevent them participating or providing full informed consent.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Changes in depressive and anxiety symptoms
Periodo de tiempo: Baseline (pre-workshop), 3-Weeks (Post-workshop), 3-, 6- and 12 Months
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Measured by the Beck Depression Inventory
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Baseline (pre-workshop), 3-Weeks (Post-workshop), 3-, 6- and 12 Months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Changes in overall well-being
Periodo de tiempo: Baseline (pre-workshop), 3-Weeks (Post-workshop), 3-, 6- and 12 Months
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Measured by the Warwick-Edinburgh Mental Wellbeing Scale
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Baseline (pre-workshop), 3-Weeks (Post-workshop), 3-, 6- and 12 Months
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Changes in perceptions of masculinity
Periodo de tiempo: Baseline (pre-workshop), 3-Weeks (Post-workshop), 3-, 6- and 12 Months
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Measured by the Personal Attributes Questionnaire
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Baseline (pre-workshop), 3-Weeks (Post-workshop), 3-, 6- and 12 Months
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Changes in perceptions of masculinity
Periodo de tiempo: Baseline (pre-workshop), 3-Weeks (Post-workshop), 3-, 6- and 12 Months
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Measured by the Masculine Behaviour Scale
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Baseline (pre-workshop), 3-Weeks (Post-workshop), 3-, 6- and 12 Months
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Group cohesion and dynamics
Periodo de tiempo: 3-Weeks (Post-workshop), 3-, 6- and 12 Months
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Measured by the Group Questionnaire
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3-Weeks (Post-workshop), 3-, 6- and 12 Months
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Patient-incurred costs for attending the session
Periodo de tiempo: 3-Weeks (Post-Workshop)
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Measured by an annotated cost questionnaire for completion by patients
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3-Weeks (Post-Workshop)
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: David Kuhl, MD, University of British Columbia
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- PCSC-6
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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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