Chemotherapy-Related Toxicities In Ovarian Cancer Patients
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | July 27, 2007 | ||||
| Last Updated Date | September 26, 2012 | ||||
| Start Date ICMJE | January 2001 | ||||
| Estimated Primary Completion Date | January 2014 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Qualitative information on how ovarian cancer patients, their family members, and doctors and nurses feel about the side-effects of chemotherapy. [ Time Frame: 8 Years ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00508378 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Patient Response to Quality of Life Using Interview + Questionnaire [ Time Frame: 30 minute interviews + 15 minutes for questionnaire ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Chemotherapy-Related Toxicities In Ovarian Cancer Patients | ||||
| Official Title ICMJE | Chemotherapy-Related Toxicities In Ovarian Cancer Patients: Preference Assessments of Patients, Family Members, Ancillary Staff and Gynecologic Oncologists, and Patients' Quality of Life | ||||
| Brief Summary | Primary Objectives:
|
||||
| Detailed Description | Patients in this study will be recruited from the Gynecologic Oncology Clinic waiting area. All participants (patients, family and clinical caregivers, control group women with no cancer) in this study will take part in an interview to see how they feel about the different side-effects of chemotherapy. The interview will involve reading short descriptions of the side-effects and then answering some questions that ask for an opinion. The actual interview will take about 30-45 minutes to complete. The interviews will either take place in private conference rooms in the clinic or in private rooms at the Ambulatory Treatment Center (ATC). Patients will also be given quality of life and symptom assessment questionnaires. The questionnaires are simple to read and quick to answer. The questionnaire takes about 15 minutes to complete. The participant's involvement in this study is limited to the questionnaire/interview. Once that is done, the participant is finished with the study. This is an investigational study. A total of 288 people will take part in this study. All will be enrolled at M. D. Anderson. |
||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Prospective |
||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Ovarian cancer patients, their family members, and doctors and nurses from the UTMDACC Gynecologic Oncology Clinic. |
||||
| Condition ICMJE | Ovarian Cancer | ||||
| Intervention ICMJE |
|
||||
| Study Group/Cohort (s) | Interview & Questionnaires
Interventions:
|
||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 288 | ||||
| Completion Date | Not Provided | ||||
| Estimated Primary Completion Date | January 2014 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
| Gender | Female | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00508378 | ||||
| Other Study ID Numbers ICMJE | GYN00-409 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | M.D. Anderson Cancer Center | ||||
| Study Sponsor ICMJE | M.D. Anderson Cancer Center | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | M.D. Anderson Cancer Center | ||||
| Verification Date | September 2012 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||