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Questionnaire Study for Gynecological Cancer Survivors
Conditions
Endometrial Neoplasms - Ovarian Neoplasms - Uterine Cervical Neoplasms - Vulvar Neoplasms - Vaginal Neoplasms - Genital Neoplasms, Female
Conditions: official terms
Endometrial Neoplasms - Genital Neoplasms, Female - Neoplasms - Ovarian Neoplasms - Uterine Cervical Neoplasms - Vaginal Neoplasms - Vulvar Neoplasms
Conditions: Keywords
Endometrial cancer, Ovarian Cancer, Cervical Cancer, Genital Cancer, Vulvar Cancer, Vaginal Cancer, Other Gynecological Cancers
Study Type
Observational
Study Phase
N/A
Study Design
Time Perspective: Prospective
Intervention
Name: Psychosocial
Type: Behavioral
Overall Status
Recruiting
Summary
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:
1. Describe quality of life (both mental health and physical functioning components), stress, and sexual functioning among survivors of gynecologic malignancies and
2. 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.
The goal of the proposed study is to evaluate quality of life in long-term gynecologic cancer survivors. The specific aims are to:
1. Describe quality of life (both mental health and physical functioning components), stress, and sexual functioning among survivors of gynecologic malignancies and
2. 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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 75 Years
Minimum Age: 20 Years
Gender: Female
Criteria: Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- Participants residing >90 miles from the research site
- Participants diagnosed with dementia
- Participants diagnosed with pregnancy
- 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
Exclusion Criteria:
- 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
- Participants residing >90 miles from the research site
- Participants diagnosed with dementia
- Participants diagnosed with pregnancy
Locations
Walter Reed Army Medical Center
Washington, District of Columbia, United States
Ohio State University
Status: Recruiting
Contact: Karen Livornese, BSN, RN - 202-782-6244 - karen.Livornese@amedd.army.mil
Columbus, Ohio, United States
Status: Active, not recruiting
Start Date
February 2006
Completion Date
February 2011
Sponsors
U.S. Army Medical Research and Materiel Command
Source
Walter Reed Army Medical Center
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page