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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:
Information provided by (Responsible Party):
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT01098630
First received: April 2, 2010
Last updated: August 8, 2014
Last verified: August 2014

April 2, 2010
August 8, 2014
July 2010
May 2012   (final data collection date for primary outcome 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    A logistic regression model analysis will be used.
  • 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 ]
Complete list of historical versions of study NCT01098630 on ClinicalTrials.gov Archive Site
  • Enrollment status [ Time Frame: 7 months ] [ Designated as safety issue: No ]
    Will be analyzed using categorical variable modeling methods. Logistic response functions will be used.
  • Patient/physician demographics [ Time Frame: 7 months ] [ Designated as safety issue: No ]
    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.
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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

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Women With Primary Or Recurrent Invasive Cancer Of The Uterine Corpus Or Uterine Cervix, All Stages

  • Recurrent Cervical Cancer
  • Recurrent Endometrial Carcinoma
  • Recurrent Uterine Sarcoma
  • Stage I Endometrial Carcinoma
  • Stage I Uterine Sarcoma
  • Stage IA Cervical Cancer
  • Stage IB Cervical Cancer
  • Stage II Endometrial Carcinoma
  • Stage II Uterine Sarcoma
  • Stage IIA Cervical Cancer
  • Stage IIB Cervical Cancer
  • Stage III Cervical Cancer
  • Stage III Endometrial Carcinoma
  • Stage III Uterine Sarcoma
  • Stage IV Endometrial Carcinoma
  • Stage IV Uterine Sarcoma
  • Stage IVA Cervical Cancer
  • Stage IVB Cervical Cancer
  • 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 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.
    Interventions:
    • Other: medical chart review
    • Other: questionnaire administration
  • 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.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
781
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May 2012   (final data collection date for primary outcome measure)

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
Female
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No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01098630
GOG-0247, NCI-2011-02033, CDR0000668836, GOG-0247, GOG-0247, GOG-0247, U10CA101165
Not Provided
Gynecologic Oncology Group
Gynecologic Oncology Group
National Cancer Institute (NCI)
Principal Investigator: Sandra Brooks Gynecologic Oncology Group
Gynecologic Oncology Group
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP