- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
-
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British Columbia
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Vancouver, British Columbia, Kanada, V5Z 1M9
- Vancouver Prostate Centre
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-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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
Hur är studien utformad?
Designdetaljer
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Changes in depressive and anxiety symptoms
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Changes in overall well-being
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 3-Weeks (Post-Workshop)
|
Measured by an annotated cost questionnaire for completion by patients
|
3-Weeks (Post-Workshop)
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: David Kuhl, MD, University of British Columbia
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- PCSC-6
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
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