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Development of a Clinical Trial Specific Question Prompt List

29. května 2013 aktualizováno: Memorial Sloan Kettering Cancer Center

The purpose of this study is to develop a Question Prompt List (QPL) about clinical trials for cancer patients and find out what cancer patients and their caregivers think of the QPL. A QPL is a list of questions patients might want to ask their doctors during their appointments.

We will conduct three focus groups to talk about using QPL's as a new way to recruit patients like you to clinical trials. The three groups will be made of patients who have and have not participated in clinical trials, their caregivers and doctors. This study is also being done to learn about how the QPL affects the question asking behavior of patients during their appointments with doctors at Memorial SloanKettering Cancer Center (MSKCC).

Přehled studie

Typ studie

Pozorovací

Zápis (Aktuální)

67

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

    • New York
      • New York, New York, Spojené státy, 10065
        • Memorial Sloan-Kettering Cancer Center

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ano

Pohlaví způsobilá ke studiu

Všechno

Metoda odběru vzorků

Vzorek nepravděpodobnosti

Studijní populace

treatment at MSKCC of lung, prostate or breast cancer A current health care professional at MSKCC current involvement in recruiting patients with lung, prostate or breast cancer to Phase I,II, or III clinical trials at MSKCC

Popis

Inclusion Criteria:

  • Population Segment 1 who have participated in a clinical trial
  • Diagnosis and treatment at MSKCC of lung, prostate or breast cancer
  • Completion of a Phase I, II, or III clinical trial at MSKCC
  • Ability to provide informed consent

Patient caregiver eligibility requirements will be:

  • Nomination by patient as the primary caregiver
  • Ability to provide informed consent

Population Segment 2 who have not participated in a clinical trial:

  • Diagnosis and treatment at MSKCC of lung, prostate or breast cancer or the primary patient caregiver
  • Ability to provide informed consent

Patient caregiver eligibility requirements will be:

  • Nomination by patient as the primary caregiver
  • Ability to provide informed consent

Population Segment 3 who are health care professionals:

  • A current health care professional at MSKCC
  • Current involvement in recruiting patients with lung, prostate or breast cancer to Phase I,II, or III clinical trials at MSKCC
  • Ability to provide informed consent

Exclusion Criteria:

Potential subjects will be considered ineligible for either/both phases of this study if they are:

  • Fewer than 18 years of age
  • Cognitively or physically impaired, rendering them incapable of providing informed consent to participate in the study
  • Population Segment 2 participants will be excluded if they have ever participated in a clinical trial.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Kohorty a intervence

Skupina / kohorta
Intervence / Léčba
1
Trial experienced cancer patients and their primary caregivers.

Focus group with MSKCC patients with lung, breast and prostate cancer who have taken part in clinical trials and other caregivers. This focus group will be audio recorded.

During the focus group, you will discuss a Question Prompt List that will be handed out to you. You will be asked about what you think of it and if you think it would have been useful to the patient you care for in his/her experience in a clinical trial.

The focus group to last from 60 to 90 minutes.

Focus group with MSKCC patients with lung, breast and prostate cancer who have not taken part in clinical trials and other caregivers. This focus group will be audio recorded.

During the focus group, you will discuss a Question Prompt List that will be handed out to you. You will be asked about what you think of it and if you think it would be useful if the patient you care for were ever to take part in a clinical trial sometime in the future.

We expect the focus group to last from 60 to 90 minutes.

MSKCC clinicians who work with lung, breast and prostate cancer patients. This focus group will be audio recorded.

During the focus group, you will discuss a Question Prompt List that will be handed out to you. You will be asked about what you think of it and if you think it would be useful to your patients who take part in clinical trials.

Expect the focus group to last from 60 to 90 minutes.

2
Trial naive cancer patients and their caregivers.

Focus group with MSKCC patients with lung, breast and prostate cancer who have taken part in clinical trials and other caregivers. This focus group will be audio recorded.

During the focus group, you will discuss a Question Prompt List that will be handed out to you. You will be asked about what you think of it and if you think it would have been useful to the patient you care for in his/her experience in a clinical trial.

The focus group to last from 60 to 90 minutes.

Focus group with MSKCC patients with lung, breast and prostate cancer who have not taken part in clinical trials and other caregivers. This focus group will be audio recorded.

During the focus group, you will discuss a Question Prompt List that will be handed out to you. You will be asked about what you think of it and if you think it would be useful if the patient you care for were ever to take part in a clinical trial sometime in the future.

We expect the focus group to last from 60 to 90 minutes.

MSKCC clinicians who work with lung, breast and prostate cancer patients. This focus group will be audio recorded.

During the focus group, you will discuss a Question Prompt List that will be handed out to you. You will be asked about what you think of it and if you think it would be useful to your patients who take part in clinical trials.

Expect the focus group to last from 60 to 90 minutes.

3
Health care professionals who are involved in running Phase I, II or III clinical trials.

Focus group with MSKCC patients with lung, breast and prostate cancer who have taken part in clinical trials and other caregivers. This focus group will be audio recorded.

During the focus group, you will discuss a Question Prompt List that will be handed out to you. You will be asked about what you think of it and if you think it would have been useful to the patient you care for in his/her experience in a clinical trial.

The focus group to last from 60 to 90 minutes.

Focus group with MSKCC patients with lung, breast and prostate cancer who have not taken part in clinical trials and other caregivers. This focus group will be audio recorded.

During the focus group, you will discuss a Question Prompt List that will be handed out to you. You will be asked about what you think of it and if you think it would be useful if the patient you care for were ever to take part in a clinical trial sometime in the future.

We expect the focus group to last from 60 to 90 minutes.

MSKCC clinicians who work with lung, breast and prostate cancer patients. This focus group will be audio recorded.

During the focus group, you will discuss a Question Prompt List that will be handed out to you. You will be asked about what you think of it and if you think it would be useful to your patients who take part in clinical trials.

Expect the focus group to last from 60 to 90 minutes.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Časové okno
To develop a targeted Question Prompt List for Clinical Trials and evaluate its acceptability to cancer patients considering clinical trial participation.
Časové okno: conclusion of study
conclusion of study

Sekundární výstupní opatření

Měření výsledku
Časové okno
To explore the utility of the Question Prompt List for Clinical Trials in oncology consultations containing a discussion of a Phase I, II or III clinical trial.
Časové okno: conclusion of study
conclusion of study

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Vyšetřovatelé

  • Vrchní vyšetřovatel: Carmen Bylund, PhD, Memorial Sloan Kettering Cancer Center

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia

1. dubna 2008

Primární dokončení (Aktuální)

1. května 2013

Dokončení studie (Aktuální)

1. května 2013

Termíny zápisu do studia

První předloženo

17. dubna 2008

První předloženo, které splnilo kritéria kontroly kvality

18. dubna 2008

První zveřejněno (Odhad)

21. dubna 2008

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Odhad)

30. května 2013

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

29. května 2013

Naposledy ověřeno

1. května 2013

Více informací

Termíny související s touto studií

Další identifikační čísla studie

  • 08-042
  • NIH/NCI R03 CA130598-01

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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