|No phase specified||Health services research||Closed||Not specified||NCI, Other||GOG-0247|
NCI-2011-02033, CDR0000668836, U10CA101165, NCT01098630
This clinical trial is studying patient, physician, and nurse factors associated with entry onto clinical trials and finishing treatment in patients with primary or recurrent uterine, endometrial, or cervical cancer. Determining how patients make decisions about participating in a clinical trial may help doctors plan clinical trials in which more patients are willing to participate and are satisfied with their decision to participate.
Further Study Information
I. To determine if there are specific, modifiable factors relative to patients, physicians, nurses, or clinical trial designs that predict enrollment or non-enrollment onto a GOG therapeutic trial for patients with primary or recurrent invasive cancer of the uterine corpus or cervix.
II. To determine if the Functional Comorbidity Index is an independent predictor of enrollment in a GOG clinical trial and if it correlates with performance status.
I. To determine, through multivariate analyses, whether the distribution of patients into a GOG clinical trial entry status categories (i.e., enrolled, not enrolled but eligible, not eligible) varies by demographics or economic status of patients, by patients' beliefs/concerns and interactions with physicians/family and friends, or by nurses' or physicians' beliefs/concerns and interactions with patients.
II. To determine whether patients' beliefs/concerns or interactions are associated with patient, nurse, or physician demographics.
III. To determine whether physicians' beliefs/concerns or interactions are associated with patient or physician demographics.
IV. To perform descriptive analysis regarding factors associated with completion of treatment through analysis of the Treatment Review Form.
OUTLINE: This is a multicenter study. Patients are assigned to 1 of 2 groups.
GROUP I (limited participation): Patients do not complete any questionnaires at baseline.
GROUP II (full participation): Patients complete the Patient Registration Survey and Patient Questionnaire at baseline.
At baseline, patients' medical record information is collected; sites complete the Functional Comorbidity Index; and physicians, nurses, and study coordinators complete the follow-up questionnaire. Staff complete the treatment review form after treatment or 7 months after study registration.
- Meets 1 of the following criteria:
- Patients with a pathologically confirmed diagnosis of a primary or recurrent invasive cancer of the uterine cervix or uterine corpus (all stages)
- Further treatment is indicated
- Treatment must take place at the GOG institution in which the patient is enrolled
- A GOG physician, nurse, or study coordinator for one of the patients described above
- Any GOG performance status
- Meets 1 of the following criteria:
- Willing and able to complete or be assisted with completion of 2 questionnaires and have limited medical history, treatment details, and demographic data collected
- Patients do not have to speak and write English (can be assisted by an interpreter)
- Willing to have limited medical history, treatment details, and demographic data collected (Patient)
- No patients who refuse treatment
- No concurrent treatment in a GOG treatment trial
- Prior participation in a GOG treatment trial allowed
Trial Lead Organizations/Sponsors
Gynecologic Oncology GroupNational Cancer Institute
|Sandra Brooks||Principal Investigator|
|GOG of Arizona, PC|
|Sandra E. Brooks||Ph: 502-899-6840|
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01098630
ClinicalTrials.gov processed this data on February 27, 2014
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