This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT01098630
First received: April 2, 2010
Last updated: October 26, 2016
Last verified: October 2016
  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. 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.

Condition Intervention
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 Other: Medical Chart Review Other: Questionnaire Administration

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Gynecologic Oncology Group:

Primary Outcome Measures:
  • 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 ]
    Two-sided Mann-Whitney U-tests will be performed.

  • Predictive value of the Functional Comorbidity Index on whether a patient is enrolled in a clinical trial [ Time Frame: 7 months ]
    A logistic regression model analysis will be used.


Secondary Outcome Measures:
  • Enrollment status [ Time Frame: 7 months ]
    Will be analyzed using categorical variable modeling methods. Logistic response functions will be used.

  • Patient/physician demographics [ Time Frame: 7 months ]
    Logistic regression analyses for ordinal categorical outcomes with more than two categories will be used to test the association of patient/physician responses with patient/physician demographics. All tests will be two-sided likelihood ration Chi-Square tests.


Enrollment: 778
Study Start Date: July 2010
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group I (limited participation)
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.
Other: Medical Chart Review
Patients' medical record information is collected and staff complete the treatment review form
Other Name: Chart Review
Other: Questionnaire Administration
Ancillary studies
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.

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.

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients With Primary or Recurrent Uterine, Endometrial, or Cervical Cancer
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01098630

  Show 167 Study Locations
Sponsors and Collaborators
Gynecologic Oncology Group
National Cancer Institute (NCI)
Investigators
Principal Investigator: Sandra Brooks Gynecologic Oncology Group
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT01098630     History of Changes
Other Study ID Numbers: GOG-0247
NCI-2011-02033 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000668836
GOG-0247 ( Other Identifier: Gynecologic Oncology Group )
GOG-0247 ( Other Identifier: DCP )
GOG-0247 ( Other Identifier: CTEP )
U10CA101165 ( U.S. NIH Grant/Contract )
Study First Received: April 2, 2010
Last Updated: October 26, 2016

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Carcinoma
Sarcoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective and Soft Tissue
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on August 17, 2017