- ICH GCP
- USA klinikai vizsgálatok nyilvántartása
- Klinikai vizsgálat NCT00662324
Development of a Clinical Trial Specific Question Prompt List
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).
A tanulmány áttekintése
Állapot
Körülmények
Beavatkozás / kezelés
Tanulmány típusa
Beiratkozás (Tényleges)
Kapcsolatok és helyek
Tanulmányi helyek
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New York
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New York, New York, Egyesült Államok, 10065
- Memorial Sloan-Kettering Cancer Center
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Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
Egészséges önkénteseket fogad
Tanulmányozható nemek
Mintavételi módszer
Tanulmányi populáció
Leírás
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.
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
Kohorszok és beavatkozások
Csoport / Kohorsz |
Beavatkozás / kezelés |
---|---|
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. |
Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Időkeret |
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To develop a targeted Question Prompt List for Clinical Trials and evaluate its acceptability to cancer patients considering clinical trial participation.
Időkeret: conclusion of study
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conclusion of study
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Másodlagos eredményintézkedések
Eredménymérő |
Időkeret |
---|---|
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.
Időkeret: conclusion of study
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conclusion of study
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Együttműködők és nyomozók
Együttműködők
Nyomozók
- Kutatásvezető: Carmen Bylund, PhD, Memorial Sloan Kettering Cancer Center
Publikációk és hasznos linkek
Hasznos linkek
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete
Elsődleges befejezés (Tényleges)
A tanulmány befejezése (Tényleges)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Becslés)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Becslés)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- 08-042
- NIH/NCI R03 CA130598-01
Ezt az információt közvetlenül a clinicaltrials.gov webhelyről szereztük be, változtatás nélkül. Ha bármilyen kérése van vizsgálati adatainak módosítására, eltávolítására vagy frissítésére, kérjük, írjon a következő címre: register@clinicaltrials.gov. Amint a változás bevezetésre kerül a clinicaltrials.gov oldalon, ez a webhelyünkön is automatikusan frissül. .
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Jonsson Comprehensive Cancer CenterNational Cancer Institute (NCI); National Institutes of Health (NIH)ToborzásAnatómiai Stage II Breast Cancer AJCC v8 | Anatómiai Stage III Breast Cancer AJCC v8 | Korai stádiumú emlőkarcinóma | Anatómiai Stage I Breast Cancer American Joint Committee on Cancer (AJCC) v8Egyesült Államok
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Mayo ClinicNational Cancer Institute (NCI)ToborzásAnatómiai stádiumú emlőrák AJCC v8 | Anatómiai Stage II Breast Cancer AJCC v8 | Anatómiai Stage III Breast Cancer AJCC v8Egyesült Államok
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University of Southern CaliforniaNational Cancer Institute (NCI)ToborzásAnatómiai stádiumú emlőrák AJCC v8 | Anatómiai Stage II Breast Cancer AJCC v8 | Anatómiai Stage III Breast Cancer AJCC v8 | Invazív emlőkarcinómaEgyesült Államok
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City of Hope Medical CenterNational Cancer Institute (NCI)ToborzásAnatómiai stádiumú emlőrák AJCC v8 | Anatómiai Stage II Breast Cancer AJCC v8 | Anatómiai Stage III Breast Cancer AJCC v8 | HER2-negatív emlőkarcinómaEgyesült Államok
Klinikai vizsgálatok a focus groups
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Macmillan Research Group UKNMP Medical Research Institute; Warwick Research ServicesBefejezveAlkoholfüggőség | Anyaghasználati zavar | Kábítószer-függőség,India
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Nantes University HospitalIsmeretlen
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Prince of Songkla UniversityBefejezveKolorektális neoplazmák | Kolorektális polipThaiföld
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Umeå UniversityMég nincs toborzásCsípőtáji törések | Érzéstelenítés | Hemodinamikai instabilitás | Echokardiográfia | Kockázatértékelés
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University of WashingtonPatient-Centered Outcomes Research InstituteMég nincs toborzásSkizofrénia | Bipoláris zavar | Major depresszív zavar | Schizo affektív zavar
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University of California, Los AngelesBefejezveDepresszió | Stressz, pszichológiai | Stressz zavarok, traumás | Szorongás | Érzelmi stressz | Trauma, pszichológiai | Viselkedés, gyermek | Szabályozás, Self
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A. Vogel AGUniversity of Newcastle Upon-TyneJelentkezés meghívóvalMentális egészség Wellness 1 | Munkával kapcsolatos stresszEgyesült Királyság
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University of California, Los AngelesVA Greater Los Angeles Healthcare SystemVisszavontVeterán családok | Családi kommunikáció | A civil élet reintegrációjaEgyesült Államok