## Protocol Section
### Identification Module
**NCT ID:** 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

#### Organization Study ID Info
**ID:** CCCWFU-99106
#### Organization
**Class:** OTHER
**Full Name:** Wake Forest University Health Sciences
#### Secondary ID Infos
**ID:** CCCWFU-99106
**ID:** CCCWFU-BG06-014
### Status Module
#### Completion Date
**Date:** 2007-02

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2018-08-09

**Type:** ACTUAL

**Last Update Submit Date:** 2018-08-07

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2007-02

**Type:** ACTUAL

#### Start Date
**Date:** 2006-02

**Type:** ACTUAL

**Status Verified Date:** 2018-08

#### Study First Post Date
**Date:** 2006-10-03
**Type:** ESTIMATED
**Study First Submit Date:** 2006-09-29
**Study First Submit QC Date:** 2006-09-29
### Sponsor Collaborators Module

#### Collaborators

**Class:** NIH

**Name:** National Cancer Institute (NCI)

#### Lead Sponsor

**Class:** OTHER

**Name:** Wake Forest University Health Sciences

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- 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

### Design Module

#### Design Info

**Primary Purpose:** OTHER

#### Enrollment Info

**Count:** 70

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

### Interventions

#### Intervention 1

**Name:** counseling intervention

**Type:** OTHER

#### Intervention 2

**Name:** study of socioeconomic and demographic variables

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Measure:** Development of a structured interview instrument

**Measure:** Recruitment strategy

### Eligibility Module

**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

**Maximum Age:** 120 Years

**Minimum Age:** 18 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Winston-Salem

**Country:** United States

**Facility:** Wake Forest University Comprehensive Cancer Center

**State:** North Carolina

**Zip:** 27157-1096

#### Overall Officials

**Official 1:**

**Affiliation:** Wake Forest University Health Sciences

**Name:** Brigitte E. Miller, MD

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000004701

- Term: Endocrine Gland Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000010049

- Term: Ovarian Diseases

- ID: D000000291

- Term: Adnexal Diseases

- ID: D000005831

- Term: Genital Diseases, Female

- ID: D000052776

- Term: Female Urogenital Diseases

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000005833

- Term: Genital Neoplasms, Female

- ID: D000014565

- Term: Urogenital Neoplasms

- ID: D000091662

- Term: Genital Diseases

- ID: D000004700

- Term: Endocrine System Diseases

- ID: D000006058

- Term: Gonadal Disorders

- ID: D000002277

- Term: Carcinoma

- ID: D000009375

- Term: Neoplasms, Glandular and Epithelial

- ID: D000009370

- Term: Neoplasms by Histologic Type

- ID: D000018204

- Term: Neoplasms, Connective and Soft Tissue

- ID: D000014594

- Term: Uterine Neoplasms

- ID: D000002577

- Term: Uterine Cervical Diseases

- ID: D000014591

- Term: Uterine Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BC19

- Name: Gland and Hormone Related Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M5830

- Name: Uterine Cervical Neoplasms

- Relevance: HIGH

- As Found: Cervical Cancer

- ID: M15327

- Name: Sarcoma

- Relevance: HIGH

- As Found: Sarcoma

- ID: M14850

- Name: Recurrence

- Relevance: LOW

- As Found: Unknown

- ID: M12974

- Name: Ovarian Neoplasms

- Relevance: HIGH

- As Found: Ovarian Cancer

- ID: M1704

- Name: Carcinoma, Ovarian Epithelial

- Relevance: HIGH

- As Found: Ovarian Cancer

- ID: M17342

- Name: Uterine Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M5225

- Name: Brenner Tumor

- Relevance: LOW

- As Found: Unknown

- ID: M5534

- Name: Carcinoma

- Relevance: LOW

- As Found: Unknown

- ID: M7863

- Name: Endocrine Gland Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M12972

- Name: Ovarian Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M3643

- Name: Adnexal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8943

- Name: Genital Diseases, Female

- Relevance: LOW

- As Found: Unknown

- ID: M2876

- Name: Genital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M8945

- Name: Genital Neoplasms, Female

- Relevance: LOW

- As Found: Unknown

- ID: M17315

- Name: Urogenital Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M7862

- Name: Endocrine System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M9163

- Name: Gonadal Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M12320

- Name: Neoplasms, Glandular and Epithelial

- Relevance: LOW

- As Found: Unknown

- ID: M12315

- Name: Neoplasms by Histologic Type

- Relevance: LOW

- As Found: Unknown

- ID: M20350

- Name: Neoplasms, Connective and Soft Tissue

- Relevance: LOW

- As Found: Unknown

- ID: M5825

- Name: Uterine Cervical Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17339

- Name: Uterine Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T5284

- Name: Soft Tissue Sarcoma

- Relevance: LOW

- As Found: Unknown

- ID: T2475

- Name: Germ Cells Tumors

- Relevance: LOW

- As Found: Unknown

- ID: T4352

- Name: Ovarian Cancer

- Relevance: HIGH

- As Found: Ovarian Cancer

- ID: T4354

- Name: Ovarian Epithelial Cancer

- Relevance: HIGH

- As Found: Ovarian Cancer

- ID: T4355

- Name: Ovarian Germ Cell Tumor

- Relevance: LOW

- As Found: Unknown

- ID: T5821

- Name: Uterine Sarcoma

- Relevance: LOW

- As Found: Unknown

- ID: T4357

- Name: Ovarian Low Malignant Potential Tumor

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000010051

- Term: Ovarian Neoplasms

- ID: D000077216

- Term: Carcinoma, Ovarian Epithelial

- ID: D000012509

- Term: Sarcoma

- ID: D000002583

- Term: Uterine Cervical Neoplasms

### Misc Info Module

- Version Holder: 2024-05-24
