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Development of a Clinical Trial Specific Question Prompt List

29. mai 2013 oppdatert av: 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).

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Observasjonsmessig

Registrering (Faktiske)

67

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • New York
      • New York, New York, Forente stater, 10065
        • Memorial Sloan-Kettering Cancer Center

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
1
Trial experienced cancer patients and their primary caregivers.
Atferdsmessig: focus groups

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.

Atferdsmessig: focus groups

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.

Atferdsmessig: focus groups

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.
Atferdsmessig: focus groups

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.

Atferdsmessig: focus groups

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.

Atferdsmessig: focus groups

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.
Atferdsmessig: focus groups

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.

Atferdsmessig: focus groups

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.

Atferdsmessig: focus groups

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.

Hva måler studien?

Primære resultatmål

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

Sekundære resultatmål

Resultatmål
Tidsramme
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.
Tidsramme: conclusion of study
conclusion of study

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Memorial Sloan Kettering Cancer Center

Samarbeidspartnere

National Cancer Institute (NCI)
National Institutes of Health (NIH)
Virginia Commonwealth University

Etterforskere

  • Hovedetterforsker: Carmen Bylund, PhD, Memorial Sloan Kettering Cancer Center

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. april 2008

Primær fullføring (Faktiske)

1. mai 2013

Studiet fullført (Faktiske)

1. mai 2013

Datoer for studieregistrering

Først innsendt

17. april 2008

Først innsendt som oppfylte QC-kriteriene

18. april 2008

Først lagt ut (Anslag)

21. april 2008

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

30. mai 2013

Siste oppdatering sendt inn som oppfylte QC-kriteriene

29. mai 2013

Sist bekreftet

1. mai 2013

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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