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

Gynecologic Oncology Group (GOG)

Status: Completed

Conditions: Stage IVA Cervical Cancer; Stage II Uterine Sarcoma; Stage I Uterine Sarcoma; Stage IB Cervical Cancer; Stage II Uterine Corpus Cancer; Stage IV Uterine Sarcoma; Recurrent Cervical Carcinoma; Stage IVB Cervical Cancer; Recurrent Uterine Corpus Carcinoma; Stage III Uterine Corpus Cancer; Stage I Uterine Corpus Cancer; Stage III Cervical Cancer; Stage IV Uterine Corpus Cancer; Stage III Uterine Sarcoma; Stage IIB Cervical Cancer; Stage IIA Cervical Cancer; Recurrent Uterine Corpus Sarcoma; Stage IA Cervical Cancer

Treatments: Other: Medical Chart Review; Other: Questionnaire Administration

Study type: Observational

Funder types: NETWORK; NIH

Identifiers

NCT01098630

GOG-0247 (Other Identifier)

CDR0000668836

U10CA101165 (U.S. NIH Grant/Contract)

NCI-2011-02033 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 778 patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

778 participants in 2 patient groups

Group I (limited participation)

Description:

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.

Treatment:

Other: Questionnaire Administration

Other: Medical Chart Review

Group II (full participation)

Description:

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.