- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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British Columbia
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Vancouver, British Columbia, Canada, V5Z 1M9
- Vancouver Prostate Centre
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Changes in depressive and anxiety symptoms
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Changes in overall well-being
Délai: Baseline (pre-workshop), 3-Weeks (Post-workshop), 3-, 6- and 12 Months
|
Measured by the Warwick-Edinburgh Mental Wellbeing Scale
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Baseline (pre-workshop), 3-Weeks (Post-workshop), 3-, 6- and 12 Months
|
|
Changes in perceptions of masculinity
Délai: 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
|
|
Changes in perceptions of masculinity
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: David Kuhl, MD, University of British Columbia
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- PCSC-6
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
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