Ovarian CancerNCT00003794
Quality-of-Life Study of Patients With Previously Treated Ovarian Cancer
An observational study of Ovarian Cancer, run by Gynecologic Oncology Group at 4 sites in United States.
Trial summary
RATIONALE: Quality-of-life assessment of patients undergoing cancer treatment may help determine the intermediate- and long-term effects of treatment in patients with cancer. PURPOSE: This clinical trial studies the quality of life in patients with previously treated ovarian cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- psychosocial assessment and care and quality-of-life assessment
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 4 sitesUnited States
- Study dates
- Apr 1999to Jul 2005
- Phase
- Observational
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS: History of early or advanced ovarian germ cell tumors Continuously disease free for at least 2 years prior to study Must have been enrolled on GOG protocols 45, 78, 90, and 116 or similar protocols of cisplatin-based chemotherapy at M.D. Anderson Cancer Center
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: Must be able to complete a written questionnaire and telephone interview in English
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery: Not specified
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Evanston Northwestern Health Care
Evanston, Illinois, 60201
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
Indiana University Cancer Center
Indianapolis, Indiana, 46202-5289
Chao Family Comprehensive Cancer Center
Orange, California, 92868
About this study
Official title: Quality of Life in Ovarian Germ Cell Cancer Survivors
RATIONALE: Quality-of-life assessment of patients undergoing cancer treatment may help determine the intermediate- and long-term effects of treatment in patients with cancer.
PURPOSE: This clinical trial studies the quality of life in patients with previously treated ovarian cancer.
Read the detailed description
OBJECTIVES: I. Compare quality of life in terms of health status, sexual functioning, psychological/emotional well being, and social functioning in ovarian germ cell cancer survivors vs a matched healthy control group. II. Predict quality of life in these patients through the additive effects of cancer diagnosis and treatment, sociodemographic characteristics, other stressors, and social network variables.
OUTLINE: Patients identify up to 3 healthy acquaintance controls within 3 years of the same age. Patients and controls complete a written questionnaire, which takes about 30 minutes, and a telephone interview, which takes about 1 hour, to assess quality of life.
PROJECTED ACCRUAL: A total of 190 patients and 190 healthy controls will be accrued for this study within 2 years.
- Conditions
- Ovarian Cancer
- Being tested
- psychosocial assessment and care, quality-of-life assessment
- Keywords
- stage I ovarian germ cell tumor, stage II ovarian germ cell tumor, stage III ovarian germ cell tumor, stage IV ovarian germ cell tumor, recurrent ovarian germ cell tumor
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
psychosocial assessment and careProcedure or surgery
quality-of-life assessmentProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2003 (estimated)
- Study startApr 1999
- Primary completionJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- 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
- Observational
Sponsor and investigators
- Lead sponsor
- Gynecologic Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Stephen D. Williams, MD, Study chair, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003794
- Sponsor's protocol ID
- CDR0000066937
- Other IDs
- GOG-9901
- Status last verified
- Nov 2005
- First submitted
- 1 Nov 1999
- Last updated
- 10 Jun 2013
- Results posted
- No
Publications
Monahan PO, Champion VL, Zhao Q, Miller AM, Gershenson D, Williams SD, Cella D. Case-control comparison of quality of life in long-term ovarian germ cell tumor survivors: a gynecologic oncology group study. J Psychosoc Oncol. 2008;26(3):19-42. doi: 10.1080/07347330802115715.
PubMed 19042263Williams SD, Miller AM, Cella D, et al.: Relationship issues and sexual functioning in ovarian germ cell cancer survivors. [Abstract] Proceedings of the American Society of Clinical Oncology 20: A-845, 2001.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life in Ovarian Germ Cell Cancer Survivors
- ClinicalTrials.gov ID
- NCT00003794
- Acronym / sponsor ID
- CDR0000066937
- Conditions
- Ovarian Cancer
- Keywords
- stage I ovarian germ cell tumor, stage II ovarian germ cell tumor, stage III ovarian germ cell tumor, stage IV ovarian germ cell tumor, recurrent ovarian germ cell tumor
- Study type
- Observational
- Recruitment status
- Terminated
- Lead sponsor
- Gynecologic Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Apr 1999
- Primary completion
- Jul 2005 (actual)
- First posted
- 29 Oct 2003 (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: Quality-of-life assessment of patients undergoing cancer treatment may help determine the intermediate- and long-term effects of treatment in patients with cancer.
PURPOSE: This clinical trial studies the quality of life in patients with previously treated ovarian cancer.
Detailed description
OBJECTIVES: I. Compare quality of life in terms of health status, sexual functioning, psychological/emotional well being, and social functioning in ovarian germ cell cancer survivors vs a matched healthy control group. II. Predict quality of life in these patients through the additive effects of cancer diagnosis and treatment, sociodemographic characteristics, other stressors, and social network variables.
OUTLINE: Patients identify up to 3 healthy acquaintance controls within 3 years of the same age. Patients and controls complete a written questionnaire, which takes about 30 minutes, and a telephone interview, which takes about 1 hour, to assess quality of life.
PROJECTED ACCRUAL: A total of 190 patients and 190 healthy controls will be accrued for this study within 2 years.
Study design
Who may qualify
- Ages
- 18 years and older
- 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 |
|---|---|---|
| psychosocial assessment and care | Procedure or surgery | – |
| quality-of-life assessment | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2013.
- Results publication: PubMed 19042263Monahan PO, Champion VL, Zhao Q, Miller AM, Gershenson D, Williams SD, Cella D. Case-control comparison of quality of life in long-term ovarian germ cell tumor survivors: a gynecologic oncology group study. J Psychosoc Oncol. 2008;26(3):19-42. doi: 10.1080/07347330802115715.
- Results publicationWilliams SD, Miller AM, Cella D, et al.: Relationship issues and sexual functioning in ovarian germ cell cancer survivors. [Abstract] Proceedings of the American Society of Clinical Oncology 20: A-845, 2001.
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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.
Stephen D. Williams, MD study chair
Indiana University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Cancer, run by Gynecologic Oncology Group at 4 sites 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: stopped early, as of the sponsor's last update on 10 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 was stopped early. Results are not available in the source record.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00003794, which also lists 2 linked publications.
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 10 Jun 2013.