Cervical CancerNCT00383279
Improving Employment in Patients Who Have Survived Cervical Cancer, Uterine Cancer, or Ovarian Cancer
A study testing counseling intervention and study of socioeconomic and demographic variables in people with Cervical Cancer and Ovarian Cancer, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 120 years, women only
- Conditions the study is for
- Cervical Cancer, Ovarian Cancer, Sarcoma
- What is being tested?
- counseling intervention and study of socioeconomic and demographic variables
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2006to Feb 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- Women only
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157-1096
About this study
Official title: Improving Employment Among Gynecologic Cancer Survivors
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.
Read the 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
- Cervical Cancer, Ovarian Cancer, Sarcoma
- Being tested
- counseling intervention, study of socioeconomic and demographic variables
- 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
- Medical subject headings
- Uterine Cervical Neoplasms, Ovarian Neoplasms, Sarcoma, Uterine Cervical Dysplasia, Carcinoma, Ovarian Epithelial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
counseling interventionOther
study of socioeconomic and demographic variablesOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of a structured interview instrument
Recruitment strategy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2006 (estimated)
- Study startFeb 2006
- Primary completionFeb 2007
- Study completionFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Brigitte E. Miller, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00383279
- Sponsor's protocol ID
- CCCWFU-99106
- Other IDs
- CCCWFU-99106, CCCWFU-BG06-014
- Status last verified
- Aug 2018
- First submitted
- 29 Sep 2006
- Last updated
- 9 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Employment Among Gynecologic Cancer Survivors
- ClinicalTrials.gov ID
- NCT00383279
- Acronym / sponsor ID
- CCCWFU-99106
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Feb 2006 (actual)
- Primary completion
- Feb 2007 (actual)
- Study completion
- Feb 2007 (actual)
- First posted
- 3 Oct 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
Who may qualify
- Ages
- 18 to 120 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| counseling intervention | Other | – |
| study of socioeconomic and demographic variables | Other | – |
Primary outcome
Development of a structured interview instrument
Recruitment strategy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2018.
Related trials for Cervical Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Proton Re-irradiation in Patients With Recurrent or Second Primary Head and Neck Cancer , a Multicentre Phase II Single Arm Trial
Head & Neck Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brigitte E. Miller, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing counseling intervention and study of socioeconomic and demographic variables in people with Cervical Cancer and Ovarian Cancer, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of a structured interview instrument. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2018.