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| Tracking Information | |||||
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| First Received Date ICMJE | July 16, 2007 | ||||
| Last Updated Date | June 22, 2009 | ||||
| Start Date ICMJE | June 2007 | ||||
| Estimated Primary Completion Date | December 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
PedsQL 4.0 Generic Core Scale [ Time Frame: The mean change in PedsQL 4.0 Generic Core Total Score over time (i.e., prior to operation vs. 6-months post-operation. The PedsQL 4.0 Generic Core will be administered to each child to ascertain their quality of life at the two time points). ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
The goal of this research study is to evaluate quality of life before and after the abdominal surgery and continuous hyperthermic peritoneal perfusion with cisplatin. [ Time Frame: 18 Months ] [ Designated as safety issue: No ] | ||||
| Change History | Complete list of historical versions of study NCT00502177 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Quality of Life Questionnaire for Pediatric Patients Undergoing Peritoneal Perfusion | ||||
| Official Title ICMJE | Quality of Life Questionnaire for Pediatric Patients Undergoing Continuous Hyperthermic Peritoneal Perfusion With Cisplatin | ||||
| Brief Summary | The overall objective of this prospective study is to provide a descriptive analysis of the quality of life of pediatric cancer patients enrolled on M. D. Anderson Cancer Center Protocol 2005-0917, "A Phase I Study of Continuous Hyperthermic Peritoneal Perfusion (CHPP) with Escalating Doses of Cisplatin for Children with Peritoneal Carcinomatosis or Advanced Peritoneal and Retroperitoneal Disease".
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| Detailed Description | Child Participant: STUDY PARTICIPATION: If you agree to take part in this study, you will complete questionnaires about your quality of life. If you do not want to participate in this study, your parent or caregiver may still participate and complete the parent/caregiver questionnaires if he/she chooses. The questionnaires will ask about your experiences with pain, nausea, anxiety, worry, thinking and reasoning ability, physical appearance, communication, and your emotional, social, school, and physical functioning. Both questionnaires should take about 10 minutes to complete in total, or longer if you need more time. You will also be asked about whether you worry about the surgery being effective. If you are 4 years old or younger, your parent/caregiver will fill out the questionnaires for you. If you are between 5 and 7 years old, the interviewer will go over the questionnaires with you. If you are between 8 and 18 years old, you will fill out the questionnaires on your own. The questionnaires will be filled out in the week before the surgery, 1 month after the surgery, and 6 months after the surgery. You will only come in if you already have a scheduled visit because of the study you are presently on. However, if you are no longer on that study then you will still be asked to complete the questionnaires at the 1- and 6-month time points. This can be done by telephone or at other regularly scheduled visits at those time points. Length of Study: Your participation in this study will be over after you finish the 6-month questionnaires. Parent/Caregiver Participant: If you agree to take part in this study, you will complete questionnaires about your perception of your child's quality of life. If your child does not want to participate in this study, you may still participate and complete the parent/caregiver questionnaire, if you so choose. If your child is too ill to participate in this study, you will not be asked to complete his/her questionnaires on his/her behalf. The questionnaires will ask about your child's quality of life regarding pain, nausea, anxiety, worry, cognitive functioning (thinking and reasoning), physical appearance, communication, and his or her emotional, social, school, and physical functioning. Both questionnaires should take about 10 minutes to complete in total. You will also be asked a surgery-specific question about whether your child worries about the effectiveness of the surgery. LENGTH OF STUDY: Your participation in this study will be over after completion of the 6-month questionnaires. This is an investigational study. Up to 17 parents and 17 children will participate in this study. All will be enrolled at M. D. Anderson. |
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| Study Phase | |||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Case Control, Prospective | ||||
| Condition ICMJE | Peritoneal Neoplasms | ||||
| Intervention ICMJE | Behavioral: Questionnaire | ||||
| Study Arms / Comparison Groups | Patients undergoing continuous hyperthermic peritoneal perfusion with cisplatin and their parents/caregivers. | ||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 34 | ||||
| Completion Date | |||||
| Estimated Primary Completion Date | December 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | up to 18 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00502177 | ||||
| Responsible Party | Holly L. Green, BS/Physician Assistant, U.T.M.D. Anderson Cancer Center | ||||
| Study ID Numbers ICMJE | 2006-1106 | ||||
| Study Sponsor ICMJE | M.D. Anderson Cancer Center | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | M.D. Anderson Cancer Center | ||||
| Verification Date | June 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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