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
  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 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
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 ] [ 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 781
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

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

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 168 Study Locations
Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Principal Investigator: Sandra Brooks Gynecologic Oncology Group
  More Information

No publications provided

Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT01098630     History of Changes
Other Study ID Numbers: GOG-0247, NCI-2011-02033, CDR0000668836, GOG-0247, GOG-0247, GOG-0247, U10CA101165
Study First Received: April 2, 2010
Last Updated: August 8, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 22, 2014