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Living With Prostate Cancer (LPC) (LPC)

1 oktober 2019 uppdaterad av: Vancouver Prostate Centre

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

This is a prospective evaluation to determine the effectiveness of the Prostate Cancer Supportive Care (PCSC) Program's group therapy program, Living with Prostate Cancer (LPC). LPC is an intervention which utilizes a small group format (5-7 participants with 2 leaders and a paraprofessional counselling student) to understand and learn how to manage emotional responses, depressive symptoms, and life stressors associated with prostate cancer. Data for this evaluation will be derived from a focus group (at 3 months) and self-report questionnaires that participants will complete immediately prior to the intervention, immediately following the intervention and at 3, 6, and 12-months post-intervention.

Studieöversikt

Status

Avslutad

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

Observationell

Inskrivning (Faktisk)

42

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

    • British Columbia
      • Vancouver, British Columbia, Kanada, V5Z 1M9
        • Vancouver Prostate Centre

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Manlig

Testmetod

Icke-sannolikhetsprov

Studera befolkning

The LPC Workshops will only include men with a diagnosis of Prostate Cancer Stages 1 to 3.

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

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

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

  • Huvudutredare: David Kuhl, MD, University of British Columbia

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

9 september 2016

Primärt slutförande (Faktisk)

30 juni 2019

Avslutad studie (Faktisk)

31 augusti 2019

Studieregistreringsdatum

Först inskickad

7 mars 2017

Först inskickad som uppfyllde QC-kriterierna

2 juni 2017

Första postat (Faktisk)

6 juni 2017

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

2 oktober 2019

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

1 oktober 2019

Senast verifierad

1 oktober 2019

Mer information

Termer relaterade till denna studie

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

3
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