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Improving Employment in Patients Who Have Survived Cervical Cancer, Uterine Cancer, or Ovarian Cancer

Primary Purpose

Cervical Cancer, Ovarian Cancer, Sarcoma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
counseling intervention
study of socioeconomic and demographic variables
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional other trial for Cervical Cancer focused on measuring recurrent cervical cancer, stage 0 cervical cancer, stage IA cervical cancer, stage IB cervical cancer, stage IIA cervical cancer, stage IIB cervical cancer, stage III cervical cancer, stage IVA cervical cancer, stage IVB cervical cancer, recurrent uterine sarcoma, stage I uterine sarcoma, stage II uterine sarcoma, stage III uterine sarcoma, stage IV uterine sarcoma, borderline ovarian surface epithelial-stromal tumor, ovarian sarcoma, ovarian stromal cancer, recurrent ovarian epithelial cancer, recurrent ovarian germ cell tumor, stage I ovarian epithelial cancer, stage I ovarian germ cell tumor, stage II ovarian epithelial cancer, stage II ovarian germ cell tumor, stage III ovarian epithelial cancer, stage III ovarian germ cell tumor, stage IV ovarian epithelial cancer, stage IV ovarian germ cell tumor

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

DISEASE CHARACTERISTICS:

  • Diagnosis of 1 of the following invasive cancers:

    • Cervical cancer
    • Uterine cancer
    • Ovarian cancer
  • Diagnosed ≥ 6 months ago
  • Any stage disease
  • Employed at the time of diagnosis, defined as working for pay ≥ 20 hours/week

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • Not specified

Sites / Locations

  • Wake Forest University Comprehensive Cancer Center

Outcomes

Primary Outcome Measures

Development of a structured interview instrument
Recruitment strategy

Secondary Outcome Measures

Full Information

First Posted
September 29, 2006
Last Updated
August 7, 2018
Sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00383279
Brief Title
Improving Employment in Patients Who Have Survived Cervical Cancer, Uterine Cancer, or Ovarian Cancer
Official Title
Improving Employment Among Gynecologic Cancer Survivors
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
February 2006 (Actual)
Primary Completion Date
February 2007 (Actual)
Study Completion Date
February 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
RATIONALE: Finding out which problems affect employment in survivors of gynecologic cancer may help in planning cancer treatment and improve the quality of life of future cancer survivors. PURPOSE: This research study is looking at ways to improve employment in patients who have survived cervical cancer, uterine cancer, or ovarian cancer.
Detailed Description
OBJECTIVES: Conduct formative work, including 4 to 5 focus groups, leading to development of a structured interview instrument assessing factors related to employment outcomes among women with gynecologic cancers. Pilot a recruitment strategy and administer the interview among a sample of 60 to 70 gynecologic cancer survivors; and, with each woman's permission, a family member, a key health care provider, and her supervisor will be interviewed. OUTLINE: This is a multicenter, pilot study. Patients complete a survey, meet with a focus group, and undergo a short interview. Patient-designated participants are also interviewed; these individuals may include a health care provider, a significant other, and/or a work supervisor. PROJECTED ACCRUAL: A total of 70 patients will be accrued for this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer, Ovarian Cancer, Sarcoma
Keywords
recurrent cervical cancer, stage 0 cervical cancer, stage IA cervical cancer, stage IB cervical cancer, stage IIA cervical cancer, stage IIB cervical cancer, stage III cervical cancer, stage IVA cervical cancer, stage IVB cervical cancer, recurrent uterine sarcoma, stage I uterine sarcoma, stage II uterine sarcoma, stage III uterine sarcoma, stage IV uterine sarcoma, borderline ovarian surface epithelial-stromal tumor, ovarian sarcoma, ovarian stromal cancer, recurrent ovarian epithelial cancer, recurrent ovarian germ cell tumor, stage I ovarian epithelial cancer, stage I ovarian germ cell tumor, stage II ovarian epithelial cancer, stage II ovarian germ cell tumor, stage III ovarian epithelial cancer, stage III ovarian germ cell tumor, stage IV ovarian epithelial cancer, stage IV ovarian germ cell tumor

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Other
Intervention Name(s)
counseling intervention
Intervention Type
Other
Intervention Name(s)
study of socioeconomic and demographic variables
Primary Outcome Measure Information:
Title
Development of a structured interview instrument
Title
Recruitment strategy

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Diagnosis of 1 of the following invasive cancers: Cervical cancer Uterine cancer Ovarian cancer Diagnosed ≥ 6 months ago Any stage disease Employed at the time of diagnosis, defined as working for pay ≥ 20 hours/week PATIENT CHARACTERISTICS: Not specified PRIOR CONCURRENT THERAPY: Not specified
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brigitte E. Miller, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest University Comprehensive Cancer Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157-1096
Country
United States

12. IPD Sharing Statement

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Improving Employment in Patients Who Have Survived Cervical Cancer, Uterine Cancer, or Ovarian Cancer

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