Endometrial NeoplasmsNCT00391664
Questionnaire Study for Gynecological Cancer Survivors
An observational study of Endometrial Neoplasms and Ovarian Neoplasms, run by U.S. Army Medical Research and Development Command at 2 sites in United States.
Trial summary
The purpose of this study is to evaluate the quality of life of long-term gynecologic cancer survivors. Read more about this study
- Who is it for?
- Ages 20 to 75 years, women only
- Conditions the study is for
- Endometrial Neoplasms, Ovarian Neoplasms, Uterine Cervical Neoplasms
- What is being tested?
- Psychosocial
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,000 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2006to Feb 2011
- 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 20 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female participants diagnosed with gynecologic cancer
- Participants between the ages of 20 and 75 years old, inclusive
- Participants previously treated for all stages (I-IV) of the following cancers: cervix; endometrium; ovary; vulva; vagina; and other genital cancers
- Participants receiving treatment for their primary cancer in the past 2-10 years
Who cannot join
- Male participants
- Participants with major psychoses (e.g. organic brain syndrome; schizophrenia; bipolar disorder; or mental retardation).
- Participants with significant hearing deficit
- Participants with prior non-gynecologic cancer diagnosis
- Participants who refused all forms of cancer treatment, whether standard of care or experimental.
- Participants with deficient ability to read/speak English
Show all 9Show fewer
- Participants residing >90 miles from the research site
- Participants diagnosed with dementia
- Participants diagnosed with pregnancy
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 1 recruiting
- Active, not recruiting
Ohio State University
Columbus, Ohio, 43210
- Recruiting
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307
Karen Livornese, BSN, RN, 202-782-6244, karen.Livornese@amedd.army.mil
Cynthia A Perry, CIP, (202) 782-8461, cynthia.perry@amedd.army.mil
About this study
Official title: Gynecologic Cancer Survivorship Survey
The purpose of this study is to evaluate the quality of life of long-term gynecologic cancer survivors.
Read the detailed description
Since the early 1970s, death rates for the major gynecological tumors have significantly declined, with a reduction of 42% for endometrial, 49% for cervix, 27% for vagina and vulva, and 11% for ovarian cancer. Thus, of the approximately 82,000 new gynecologic cases each year, more women will be living and, necessarily be forced to cope with psychological or behavioral morbidity. Psychosocial data on cancer patients portray significant fear and anxiety with diagnosis and treatments and the potential for high levels of psychological and sexual morbidity. While many studies have been done investigating sexual outcomes, little data is available on basic domains of quality of life, i.e. emotional or social adjustment, occupational outcomes, or aspects of physical health that might influence quality of life for gynecologic cancer survivors. There is a need for basic descriptive research in these areas, particularly in investigations that include representative samples from differing socioeconomic and racial/ethnic groups.
The goal of the proposed study is to evaluate quality of life in long-term gynecologic cancer survivors. The specific aims are to:
- Describe quality of life (both mental health and physical functioning components), stress, and sexual functioning among survivors of gynecologic malignancies and
- Describe differences between disease site groups (i.e. cervical, endometrial, ovarian, and vulva).
It has been shown with other cancer groups that improvements in mood and coping can be achieved with brief, cost effective interventions (e.g. ten therapy hours with delivery in a group format). These are multi-modal interventions with stress reduction, disease/treatment information, cognitive behavioral coping strategies, and social support. There is suggestive evidence that disease specific interventions, such as including sexual therapies for gynecologic patients, can result in improvements as well. Research focus on these issues is aided by the availability of reliable and valid strategies to assess both quality of life (SF-36; FACT) and sexuality. Before clinical trials are undertaken, research must provide a comprehensive assessment of quality of life for gynecologic cancer survivors.
- Conditions
- Endometrial Neoplasms, Ovarian Neoplasms, Uterine Cervical Neoplasms, Vulvar Neoplasms, Vaginal Neoplasms, Genital Neoplasms, Female
- Being tested
- Psychosocial
- Keywords
- Endometrial cancer, Ovarian Cancer, Cervical Cancer, Genital Cancer, Vulvar Cancer, Vaginal Cancer, Other Gynecological Cancers
- Medical subject headings
- Endometrial Neoplasms, Ovarian Neoplasms, Uterine Cervical Neoplasms, Vulvar Neoplasms, Vaginal Neoplasms, Genital Neoplasms, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsychosocialBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2006 (estimated)
- Study startFeb 2006
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial NeoplasmsStudies 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
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- U.S. Army Medical Research and Development Command
- Sponsor type
- US federal agency
- Collaborators
- Walter Reed Army Medical Center, Ohio State University
- Investigators
- Barbara L Andersen, PhD, Study director, Ohio State UniversityLTC G. Larry Maxwell, MD, Principal investigator, Walter Reed Army Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00391664
- Sponsor's protocol ID
- 05-44025
- Status last verified
- Jun 2008
- First submitted
- 23 Oct 2006
- Last updated
- 30 Jun 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gynecologic Cancer Survivorship Survey
- ClinicalTrials.gov ID
- NCT00391664
- Acronym / sponsor ID
- 05-44025
- Conditions
- Endometrial Neoplasms, Ovarian Neoplasms, Uterine Cervical Neoplasms, Vulvar Neoplasms, Vaginal Neoplasms, Genital Neoplasms, Female
- Keywords
- Endometrial cancer, Ovarian Cancer, Cervical Cancer, Genital Cancer, Vulvar Cancer, Vaginal Cancer, Other Gynecological Cancers
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- U.S. Army Medical Research and Development CommandUS federal agency
- Collaborators
- Walter Reed Army Medical Center, Ohio State University
- Study start
- Feb 2006
- Study completion
- Feb 2011
- First posted
- 24 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.
The purpose of this study is to evaluate the quality of life of long-term gynecologic cancer survivors.
Detailed description
Since the early 1970s, death rates for the major gynecological tumors have significantly declined, with a reduction of 42% for endometrial, 49% for cervix, 27% for vagina and vulva, and 11% for ovarian cancer. Thus, of the approximately 82,000 new gynecologic cases each year, more women will be living and, necessarily be forced to cope with psychological or behavioral morbidity. Psychosocial data on cancer patients portray significant fear and anxiety with diagnosis and treatments and the potential for high levels of psychological and sexual morbidity. While many studies have been done investigating sexual outcomes, little data is available on basic domains of quality of life, i.e. emotional or social adjustment, occupational outcomes, or aspects of physical health that might influence quality of life for gynecologic cancer survivors. There is a need for basic descriptive research in these areas, particularly in investigations that include representative samples from differing socioeconomic and racial/ethnic groups.
The goal of the proposed study is to evaluate quality of life in long-term gynecologic cancer survivors. The specific aims are to:
- Describe quality of life (both mental health and physical functioning components), stress, and sexual functioning among survivors of gynecologic malignancies and
- Describe differences between disease site groups (i.e. cervical, endometrial, ovarian, and vulva).
It has been shown with other cancer groups that improvements in mood and coping can be achieved with brief, cost effective interventions (e.g. ten therapy hours with delivery in a group format). These are multi-modal interventions with stress reduction, disease/treatment information, cognitive behavioral coping strategies, and social support. There is suggestive evidence that disease specific interventions, such as including sexual therapies for gynecologic patients, can result in improvements as well. Research focus on these issues is aided by the availability of reliable and valid strategies to assess both quality of life (SF-36; FACT) and sexuality. Before clinical trials are undertaken, research must provide a comprehensive assessment of quality of life for gynecologic cancer survivors.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female participants diagnosed with gynecologic cancer
- Participants between the ages of 20 and 75 years old, inclusive
- Participants previously treated for all stages (I-IV) of the following cancers: cervix; endometrium; ovary; vulva; vagina; and other genital cancers
- Participants receiving treatment for their primary cancer in the past 2-10 years
Key exclusion criteria (9 listed)
- Male participants
- Participants with major psychoses (e.g. organic brain syndrome; schizophrenia; bipolar disorder; or mental retardation).
- Participants with significant hearing deficit
- Participants with prior non-gynecologic cancer diagnosis
- Participants who refused all forms of cancer treatment, whether standard of care or experimental.
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 | Behavioural | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2008.
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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.
Barbara L Andersen, PhD study director
Ohio State University
LTC G. Larry Maxwell, MD principal investigator
Walter Reed Army Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometrial Neoplasms and Ovarian Neoplasms, run by U.S. Army Medical Research and Development Command at 2 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?
The sponsor lists 4 inclusion and 9 exclusion criteria. 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: status not confirmed, as of the sponsor's last update on 30 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Laura Petersen ((614) 292-6874, peterson.266@osu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 30 Jun 2008.