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Living With Prostate Cancer (LPC) (LPC)

1. oktober 2019 opdateret af: 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.

Studieoversigt

Status

Afsluttet

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

Observationel

Tilmelding (Faktiske)

42

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Han

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

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

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: David Kuhl, MD, University of British Columbia

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

9. september 2016

Primær færdiggørelse (Faktiske)

30. juni 2019

Studieafslutning (Faktiske)

31. august 2019

Datoer for studieregistrering

Først indsendt

7. marts 2017

Først indsendt, der opfyldte QC-kriterier

2. juni 2017

Først opslået (Faktiske)

6. juni 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

2. oktober 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. oktober 2019

Sidst verificeret

1. oktober 2019

Mere information

Begreber relateret til denne undersøgelse

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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 .

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