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Development of a Clinical Trial Specific Question Prompt List

29 mai 2013 mis à jour par: 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).

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Type d'étude

Observationnel

Inscription (Réel)

67

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • États-Unis
    • New York
      • New York, New York, États-Unis, 10065
        • Memorial Sloan-Kettering Cancer Center

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

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

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Cohortes et interventions

Groupe / Cohorte
Intervention / Traitement
1
Trial experienced cancer patients and their primary caregivers.
Comportemental: 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.

Comportemental: 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.

Comportemental: 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.
Comportemental: 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.

Comportemental: 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.

Comportemental: 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.
Comportemental: 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.

Comportemental: 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.

Comportemental: 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.

Que mesure l'étude ?

Principaux critères de jugement

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

Mesures de résultats secondaires

Mesure des résultats
Délai
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.
Délai: conclusion of study
conclusion of study

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Memorial Sloan Kettering Cancer Center

Collaborateurs

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

Les enquêteurs

  • Chercheur principal: Carmen Bylund, PhD, Memorial Sloan Kettering Cancer Center

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Liens utiles

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 avril 2008

Achèvement primaire (Réel)

1 mai 2013

Achèvement de l'étude (Réel)

1 mai 2013

Dates d'inscription aux études

Première soumission

17 avril 2008

Première soumission répondant aux critères de contrôle qualité

18 avril 2008

Première publication (Estimation)

21 avril 2008

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

30 mai 2013

Dernière mise à jour soumise répondant aux critères de contrôle qualité

29 mai 2013

Dernière vérification

1 mai 2013

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

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

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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