|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | July 10, 2007 | ||||
| Last Updated Date | September 9, 2009 | ||||
| Start Date ICMJE | August 2005 | ||||
| Estimated Primary Completion Date | August 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Patient Response to Questionnaire (Spiritual assessments) [ Time Frame: From diagnosis to completion of primary therapy and to 1 year after completion of primary therapy. ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
The goal of this psychosocial research study is to examine and explain the influence of spirituality on patients with ovarian, primary peritoneal or fallopian tube cancer. [ Time Frame: 3 Years ] [ Designated as safety issue: No ] | ||||
| Change History | Complete list of historical versions of study NCT00499512 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Role of Spirituality in Coping and Surviving With Ovarian Cancer, Primary Peritoneal or Fallopian Tube Cancer | ||||
| Official Title ICMJE | Evaluation of the Role of Spirituality in Coping With and Surviving Ovarian, Primary Peritoneal or Fallopian Tube Cancer | ||||
| Brief Summary | The goal of this psychosocial research study is to examine and explain the influence of spirituality on patients with ovarian, primary peritoneal or fallopian tube cancer. Primary Objectives:
Secondary Objectives:
|
||||
| Detailed Description | 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. |
||||
| Study Phase | |||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Case-Only, Prospective | ||||
| Condition ICMJE |
|
||||
| Intervention ICMJE | Behavioral: Questionnaire | ||||
| Study Arms / Comparison Groups | Patients with newly diagnosed ovarian, primary peritoneal, or fallopian tube cancer. | ||||
| Publications * | |||||
|
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 115 | ||||
| Completion Date | |||||
| Estimated Primary Completion Date | August 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
| Gender | Female | ||||
| Ages | |||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
|
||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00499512 | ||||
| Responsible Party | Lois M. Ramondetta, MD/Associate Professor, U.T.M.D. Anderson Cancer Center | ||||
| Study ID Numbers ICMJE | 2004-0283 | ||||
| Study Sponsor ICMJE | M.D. Anderson Cancer Center | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
|
||||
| Information Provided By | M.D. Anderson Cancer Center | ||||
| Verification Date | September 2009 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||