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

Completed

• Conditions: Stage I Uterine Sarcoma; Stage IB Cervical Cancer; Stage II Uterine Corpus Cancer; Stage II Uterine Sarcoma; Stage III Uterine Corpus Cancer; Stage IVA Cervical Cancer; Stage I Uterine Corpus Cancer; Stage III Cervical Cancer; Stage IVB Cervical Cancer; Recurrent Uterine Corpus Carcinoma

• Registration Number: NCT01098630
• Lead Sponsor: Gynecologic Oncology Group

Brief 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.

Study Timeline

• Study First Submitted: 2010-04-02
• Study First Submitted QC: 2010-04-02
• Study First Posted: 2010-04-05
• Study Start: 2010-07
• Primary Completion: 2012-05
• Study Completion: 2018-01-27
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-11
• Last Update Posted: 2018-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 778

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Predictive value of modifiable patient, physician, or clinical trial specific factors on enrollment or non-enrollment onto a treatment clinical trial	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	7 months	A logistic regression model analysis will be used.

Secondary Outcome Measures

Name	Time	Method
Patient/physician demographics	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 status	7 months	Will be analyzed using categorical variable modeling methods. Logistic response functions will be used.

Trial Locations

Locations (167)

Gynecologic Oncology Group of Arizona; 🇺🇸 Phoenix, Arizona, United States

University of Arizona Cancer Center-North Campus; 🇺🇸 Tucson, Arizona, United States

Providence Saint Joseph Medical Center/Disney Family Cancer Center; 🇺🇸 Burbank, California, United States

Roy and Patricia Disney Family Cancer Center; 🇺🇸 Burbank, California, United States

John Muir Medical Center-Concord Campus; 🇺🇸 Concord, California, United States

University of California San Diego; 🇺🇸 San Diego, California, United States

John Muir Medical Center-Walnut Creek; 🇺🇸 Walnut Creek, California, United States

Smilow Cancer Hospital Care Center at Saint Francis; 🇺🇸 Hartford, Connecticut, United States

The Hospital of Central Connecticut; 🇺🇸 New Britain, Connecticut, United States

Florida Hospital Orlando; 🇺🇸 Orlando, Florida, United States

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