- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
-
-
British Columbia
-
Vancouver, British Columbia, Canada, V5Z 1M9
- Vancouver Prostate Centre
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Changes in depressive and anxiety symptoms
Tidsramme: Baseline (pre-workshop), 3-Weeks (Post-workshop), 3-, 6- and 12 Months
|
Measured by the Beck Depression Inventory
|
Baseline (pre-workshop), 3-Weeks (Post-workshop), 3-, 6- and 12 Months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Changes in overall well-being
Tidsramme: Baseline (pre-workshop), 3-Weeks (Post-workshop), 3-, 6- and 12 Months
|
Measured by the Warwick-Edinburgh Mental Wellbeing Scale
|
Baseline (pre-workshop), 3-Weeks (Post-workshop), 3-, 6- and 12 Months
|
|
Changes in perceptions of masculinity
Tidsramme: Baseline (pre-workshop), 3-Weeks (Post-workshop), 3-, 6- and 12 Months
|
Measured by the Personal Attributes Questionnaire
|
Baseline (pre-workshop), 3-Weeks (Post-workshop), 3-, 6- and 12 Months
|
|
Changes in perceptions of masculinity
Tidsramme: Baseline (pre-workshop), 3-Weeks (Post-workshop), 3-, 6- and 12 Months
|
Measured by the Masculine Behaviour Scale
|
Baseline (pre-workshop), 3-Weeks (Post-workshop), 3-, 6- and 12 Months
|
|
Group cohesion and dynamics
Tidsramme: 3-Weeks (Post-workshop), 3-, 6- and 12 Months
|
Measured by the Group Questionnaire
|
3-Weeks (Post-workshop), 3-, 6- and 12 Months
|
|
Patient-incurred costs for attending the session
Tidsramme: 3-Weeks (Post-Workshop)
|
Measured by an annotated cost questionnaire for completion by patients
|
3-Weeks (Post-Workshop)
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: David Kuhl, MD, University of British Columbia
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- PCSC-6
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .