Clinical Trials Directory

Trials / Completed

CompletedNCT01098630

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

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

Status
Completed
Phase
—
Study type
Observational
Enrollment
778 (actual)
Sponsor
Gynecologic Oncology Group · Network
Sex
Female
Age
—
Healthy volunteers
Not accepted

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.

Detailed 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.

Conditions

Interventions

TypeNameDescription
OTHERMedical Chart ReviewPatients' medical record information is collected and staff complete the treatment review form
OTHERQuestionnaire AdministrationAncillary studies

Timeline

Start date
2010-07-01
Primary completion
2012-05-01
Completion
2018-01-27
First posted
2010-04-05
Last updated
2018-04-12

Locations

167 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT01098630. Inclusion in this directory is not an endorsement.