Treatment Preference and Patient Centered Prostate Cancer Care
17. juli 2020 opdateret af: University of Pennsylvania
The purpose of this study is to develop a preference based decision aid to assess the treatment preferences of prostate cancer patients, and to analyze the interaction of treatment preferences, type of treatment received and their relationship with health related quality of life, satisfaction with care, decision regret, and psychological health of men with localized prostate cancer.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
The objective is to test the comparative effectiveness of a conjoint analysis decision aid intervention compared to usual care.
The investigators will identify preferred attributes of prostate cancer treatments that will help in designing a conjoint analysis decision aid to help patients weigh treatment attributes.
The investigators will employ values markers to represent clusters of values for particular aspects of treatments that are valued most by individual patients.
The investigators will test if the concordance between values markers and treatment received is predictive of objective outcomes and subjective outcomes.
The study hypothesis is that conjoint task may help in treatment choice and prostate cancer patients whose treatment is more concordant with their values markers will have improved outcomes.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
743
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Pennsylvania
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Philadelphia, Pennsylvania, Forenede Stater, 19111
- Fox Chase Cancer Center
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Philadelphia, Pennsylvania, Forenede Stater, 19104
- University of Pennsylvania Health System
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Philadelphia, Pennsylvania, Forenede Stater, 19104
- Philadelphia Veteran's Affairs Medical Center
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-
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
Beskrivelse
Inclusion Criteria:
- Newly diagnosed with non-metastatic prostate cancer
- Has not yet started radiation or surgery
- Provide informed consent
Exclusion Criteria:
- Distant, metastatic prostate cancer at diagnosis
- Has already begun treatment for prostate cancer
- Unable to communicate in English
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Preference Based Decision Aid
The experimental arm of preference based decision aid intervention will complete a web-based conjoint analysis instrument for preference assessment.
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The objective of the preference based decision aid is to assess the treatment preferences of prostate cancer patients.
The investigators will analyze the association between preferences, treatment choice and objective and subjective outcomes.
The preference based decision aid will lead to a values-based patient centered treatment decision making.
This will ultimately improve clinical decision making, clinical policy process, enhance patient centered care and improve prostate cancer outcomes.
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Ingen indgriben: Usual Care
Participants randomized into this group will have usual care from their doctors without any intervention
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change in Satisfaction With Care
Tidsramme: baseline, 3, 6, 12 and 24 months
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The investigators will measure Satisfaction with Care (PSQ-18).
: The PSQ-18 scale measures satisfaction with care at baseline 3, 6, 12, and 24 months.
Higher score indicates better satisfaction with care.
Positive change indicates improvement in satisfaction with care.
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baseline, 3, 6, 12 and 24 months
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Generic Health Related Quality of Life (HRQoL)
Tidsramme: baseline to 24 month
|
Generic HRQoL data is obtained from Medical Outcome Study Short Form (SF-36) that assesses 8 health domains.
Scores on each domain range from 0 to 100, higher scores indicating better generic HRQoL.
Change in SF-36 domain scores between baseline to 24 month will be calculated as score at 24 month-score minus score at baseline.
Positive change value indicates improvement in HRQoL from baseline to 24 month.
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baseline to 24 month
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Anxiety
Tidsramme: baseline, 3, 6, 12, and 24 months
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Anxiety will be measured using Memorial Anxiety Scale for Prostate Cancer (MAX-PC) scale
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baseline, 3, 6, 12, and 24 months
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Urinary Symptoms
Tidsramme: baseline, 3, 6, 12, and 24 months
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The American Urological Association Symptom Index (AUA-SI) will be used to measured urinary symptoms
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baseline, 3, 6, 12, and 24 months
|
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Treatment Choice
Tidsramme: 6 months
|
The investigators will obtain data on primary and secondary treatments received, such as active surveillance, radical prostatectomy (RP), robotic-assisted laparoscopic prostatectomy (RALP), external beam radiation therapy (EBRT), brachytherapy (BT) or proton therapy (PT) via self report and verified from medical chart review.
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6 months
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Depression
Tidsramme: baseline, 3, 6, 12, and 24 months
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The Center for Epidemiologic Studies Depression (CES-D) scale will be used to measure depression.
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baseline, 3, 6, 12, and 24 months
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Satisfaction With Decision
Tidsramme: baseline, 3, 6, 12, and 24 months
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The Satisfaction with Decision (SWD) will be used to measure satisfaction with decision at 3, 6, 12 and 24 months.
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baseline, 3, 6, 12, and 24 months
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Prostate Specific Health Related Quality of Life (HRQoL)
Tidsramme: Baseline to 24 month
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Prostate specific HRQoL data is obtained from Expanded Prostate Cancer Index (EPIC), and measures four broad domains of urinary, bowel, sexual and hormonal symptoms.
Scores on each sub-scale range from 0 to 100, with higher scores indicating better prostate cancer HRQoL.
Proportion of participants returning to baseline scores will be calculated by comparing scores at baseline and at 24 month.
Higher proportion indicates higher number of participants recovering baseline function by 24 month.
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Baseline to 24 month
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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Preference for Participation in Treatment Decision
Tidsramme: baseline, 3, 6, 12, and 24 months
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The Control Preferences Scale (CPS) assesses the role that patients want to play and perceive playing in treatment decisions.
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baseline, 3, 6, 12, and 24 months
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Decision Conflict
Tidsramme: 12 and 24 months
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The Decision Conflict Scale (DCS) will be used to measure decision conflict.
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12 and 24 months
|
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Physician Trust
Tidsramme: baseline
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The Patient Trust-Wake Forest Physician Trust Scale will be used to measure trust
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baseline
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Ravishankar Jayadevappa, PhD, University of Pennsylvania
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
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
1. juni 2013
Primær færdiggørelse (Faktiske)
26. januar 2018
Studieafslutning (Faktiske)
26. januar 2018
Datoer for studieregistrering
Først indsendt
23. december 2013
Først indsendt, der opfyldte QC-kriterier
9. januar 2014
Først opslået (Skøn)
10. januar 2014
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
4. august 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
17. juli 2020
Sidst verificeret
1. juli 2020
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- PCC201
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 .