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Sponsored by: |
M.D. Anderson Cancer Center |
Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00499512 |
Primary Objectives:
Secondary Objectives:
Condition | Intervention |
Ovarian Cancer Peritoneal Cancer Fallopian Tube Cancer |
Behavioral: Questionnaire |
MedlinePlus related topics: | Cancer Ovarian Cancer |
Study Type: | Observational |
Study Design: | Case-Only, Prospective |
Official Title: | Evaluation of the Role of Spirituality in Coping With and Surviving Ovarian, Primary Peritoneal or Fallopian Tube Cancer |
Estimated Enrollment: | 115 |
Study Start Date: | August 2005 |
Estimated Study Completion Date: | September 2009 |
Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
1
Patients with newly diagnosed ovarian, primary peritoneal, or fallopian tube cancer.
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Behavioral: Questionnaire
Questionnaires at the time of diagnosis, end of primary chemotherapy, and one year later.
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Little is known about the role a patient's spirituality plays in their quality of life. This study consists of a series of questionnaires that ask questions about religion, spirituality, and decisions about treatment.
All patients with newly diagnosed ovarian, primary peritoneal or fallopian tube cancer who come to the Department of Gynecologic Oncology at M. D. Anderson and affiliated clinics for care will be offered study participation.
Patients will be asked to complete a series of questionnaires at specific times: at the time of diagnosis (before their second cycle of therapy begins), at the end of primary chemotherapy, and one year later. The questionnaires should take a total of about 65 minutes to complete, and patients can choose not to answer any question they do not want to answer.
Patients who agree to participate but do not have time to fill out the questionnaires during their visits may return the questionnaire by mail in a pre-stamped envelope.
All participants will be asked to provide the following information: their age, religious preference, race, marital status, date of diagnosis, stage of disease, and their current treatment. This information will be on a data sheet and should take about 5 minutes to complete.
Any collected information will be confidential. Each participant will be given a specific identification number so that confidentiality can be maintained.
This study is partially funded by a research grant from the Blanton Davis Ovarian Cancer Research Program, in Department of Gynecologic Oncology at M. D. Anderson.
This is an investigational study. About 115 participants will be enrolled in this multicenter study. About 60 participants will be enrolled at M. D. Anderson.
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Patients with newly diagnosed ovarian, primary peritoneal or fallopian tube cancer.
Inclusion Criteria:
All newly diagnosed Stage II-IV ovarian, primary peritoneal, or fallopian tube cancer patients prior to initiating C2 of chemo. A patient with synchronous primary endometrial cancer, or HX of primary endometrial cancer, can participate if these conditions are met:
Exclusion Criteria:
Contact: Lois M. Ramondetta, MD | 713-745-5238 |
United States, Texas | |||||
U.T.M.D. Anderson Cancer Center | Recruiting | ||||
Houston, Texas, United States, 77030 | |||||
Principal Investigator: Lois M. Ramondetta, MD | |||||
Lyndon B. Johnson General Hospital | Recruiting | ||||
Houston, Texas, United States, 77030 | |||||
St. Luke's Episcopal Hospital | Recruiting | ||||
Houston, Texas, United States, 77030 | |||||
The Woman's Hospital of Texas | Recruiting | ||||
Houston, Texas, United States, 77054 |
M.D. Anderson Cancer Center |
Principal Investigator: | Lois M. Ramondetta, MD | U.T.M.D. Anderson Cancer Center |
MD Anderson Cancer Center website 
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Responsible Party: | U.T.M.D. Anderson Cancer Center ( Lois M. Ramondetta, MD/Associate Professor ) |
Study ID Numbers: | 2004-0283 |
First Received: | July 10, 2007 |
Last Updated: | September 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00499512 |
Health Authority: | United States: Institutional Review Board |
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