Overview

This trial is active, not recruiting.

Conditions recurrent cervical carcinoma, recurrent uterine corpus carcinoma, recurrent uterine corpus sarcoma, stage i uterine corpus cancer, stage i uterine sarcoma, stage ia cervical cancer, stage ib cervical cancer, stage ii uterine corpus cancer, stage ii uterine sarcoma, stage iia cervical cancer, stage iib cervical cancer, stage iii cervical cancer, stage iii uterine corpus cancer, stage iii uterine sarcoma, stage iv uterine corpus cancer, stage iv uterine sarcoma, stage iva cervical cancer, stage ivb cervical cancer
Treatments medical chart review, questionnaire administration
Sponsor Gynecologic Oncology Group
Collaborator National Cancer Institute (NCI)
Start date July 2010
End date May 2012
Trial size 778 participants
Trial identifier NCT01098630, CDR0000668836, GOG-0247, NCI-2011-02033, U10CA101165

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Patients do not complete any questionnaires 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.
medical chart review Chart Review
Patients' medical record information is collected and staff complete the treatment review form
questionnaire administration
Ancillary studies
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.

Primary Outcomes

Measure
Predictive value of modifiable patient, physician, or clinical trial specific factors on enrollment or non-enrollment onto a treatment clinical trial
time frame: 7 months
Predictive value of the Functional Comorbidity Index on whether a patient is enrolled in a clinical trial
time frame: 7 months

Secondary Outcomes

Measure
Enrollment status
time frame: 7 months
Patient/physician demographics
time frame: 7 months

Eligibility Criteria

Female participants of any age.

Inclusion Criteria: - 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

Additional Information

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
Principal investigator Sandra Brooks
Description PRIMARY OBJECTIVES: 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. SECONDARY OBJECTIVES: 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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Gynecologic Oncology Group.