| 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
Basic Trial Information
Trial Description
Summary
Further Trial Information
Eligibility Criteria
Trial Contact Information
Basic Trial Information
| Phase | Type | Status | Age | Protocol IDs |
|---|
| No phase specified | Health services research | Closed | Not specified | CDR0000668836
GOG-0247, NCT01098630 |
Trial Description
Summary RATIONALE: 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. PURPOSE: 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. Further Study Information OBJECTIVES: Primary - 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.
- 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.
Secondary - 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.
- To determine whether patients' beliefs/concerns or interactions are associated with patient, nurse, or physician demographics.
- To determine whether physicians' beliefs/concerns or interactions are associated with patient or physician demographics.
- To perform descriptive analysis regarding factors associated with completion of treatment through analysis of the Treatment Review Form.
OUTLINE: This is a multicenter study. 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. Patients may also complete the Patient Registration Survey and Patient Questionnaire at baseline. Staff complete the treatment review form after treatment or 7 months after study registration. Eligibility Criteria DISEASE CHARACTERISTICS: - 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
PATIENT CHARACTERISTICS: - 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
PRIOR CONCURRENT THERAPY: - No concurrent treatment in a GOG treatment trial
- Prior participation in a GOG treatment trial allowed
Trial Contact Information
Trial Lead Organizations/Sponsors Gynecologic Oncology Group National Cancer Institute
| Sandra E. Brooks |  | Study Chair |
Trial Sites
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01098630
Information obtained from ClinicalTrials.gov on December 18, 2012 Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain
the same text. Minor
changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and
contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should
be directed to ClinicalTrials.gov.
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