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
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Cervical Cancer Endometrial Cancer Sarcoma |
Other: communication analysis Other: medical chart review Other: questionnaire administration Other: study of socioeconomic and demographic variables |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Health Services Research |
| Official Title: | Patient, Physician And Nurse Factors Associated With Entry Onto Clinical Trials And Completion Of Treatment For Women With Primary Or Recurrent Invasive Cancer Of The Uterine Corpus Or Uterine Cervix, All Stages |
- Predictive value of modifiable patient, physician, or clinical trial specific factors on enrollment or non-enrollment onto a treatment clinical trial [ Designated as safety issue: No ]
- Predictive value of the Functional Comorbidity Index on whether a patient is enrolled in a clinical trial [ Designated as safety issue: No ]
| Estimated Enrollment: | 410 |
| Study Start Date: | July 2010 |
| Estimated Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
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| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Show 152 Study Locations| Study Chair: | Sandra E. Brooks, MD | Norton Cancer Institute |
More Information
Additional Information:
No publications provided
| Responsible Party: | Philip J. DiSaia, Gynecologic Oncology Group |
| ClinicalTrials.gov Identifier: | NCT01098630 History of Changes |
| Other Study ID Numbers: | CDR0000668836, GOG-0247 |
| Study First Received: | April 2, 2010 |
| Last Updated: | January 19, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
recurrent cervical cancer stage IA cervical cancer stage IB cervical cancer stage IIA cervical cancer stage IIB cervical cancer stage III cervical cancer stage IVA cervical cancer stage IVB cervical cancer recurrent endometrial carcinoma |
stage I endometrial carcinoma stage II endometrial carcinoma stage III endometrial carcinoma stage IV endometrial carcinoma recurrent uterine sarcoma stage I uterine sarcoma stage II uterine sarcoma stage III uterine sarcoma stage IV uterine sarcoma |
Additional relevant MeSH terms:
|
Endometrial Neoplasms Uterine Cervical Neoplasms Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Neoplasms Uterine Cervical Diseases |
Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Adenoma Sarcoma Uterine Diseases Genital Diseases, Female |
ClinicalTrials.gov processed this record on May 23, 2013