Concurrent School Attendance And Cancer Therapy: The Experiences of 6-12 Year Old Pediatric Oncology Patients
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | June 27, 2011 | ||||
| Last Updated Date | February 18, 2013 | ||||
| Start Date ICMJE | August 2011 | ||||
| Estimated Primary Completion Date | June 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
6-12 year old pediatric oncology patients' perceptions of their school experiences pre and post cancer diagnosis will be explored; [ Time Frame: 1 year ] [ Designated as safety issue: No ] This will be done through interviews and drawings. |
||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01383473 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| 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 | Concurrent School Attendance And Cancer Therapy: The Experiences of 6-12 Year Old Pediatric Oncology Patients | ||||
| Official Title ICMJE | Concurrent School Attendance And Cancer Therapy: The Experiences of 6-12 Year Old Pediatric Oncology Patients | ||||
| Brief Summary | Many children with cancer cannot participate regularly in school due to frequent hospitalizations for treatment or treatment related effects such as pain, nausea, and fatigue. Prior studies have shown that children with cancer desire to attend school while receiving therapy despite these challenges, and that they report psychological and psychosocial difficulties if unable to attend. While school attendance has been found to correlate with Health-Related Quality of Life (HRQoL), self-efficacy beliefs, and self-esteem, little is known about how children with cancer experience school attendance while receiving active cancer therapy. The purpose of this study will be to explore how 6-12 year old children with cancer perceive school attendance pre and post diagnosis during active therapy as measured at one-time point, 6 months (± 2months) into active therapy. |
||||
| Detailed Description | The primary objective of this study is to explore 6-12 year old pediatric oncology patients' perceptions of their school experiences pre and post cancer diagnosis. This study will utilize qualitative interview methods. Potential participants who meet inclusion criteria will be approached by the principal investigator to obtain consent and assent in accordance with institutional guidelines. Upon giving consent, the child will participate in a one-hour audio-taped interview session with the principal investigator. The interview session will begin with some general rapport building questions to help the child grow comfortable with the interviewer, the interview room, and the interview format. The rest of the interview will consist of questions pertaining to the child's school experiences both before and during diagnosis and treatment for malignancy. The interview will conclude with the child being asked to draw a picture of themselves at school before diagnosis, and of themselves at school since being diagnosed. Demographic data will be collected from each participant's medical chart pertaining to age, gender, ethnicity, diagnosis, and the type of school attended before and after diagnosis and the principal investigator and study staff involved in data coding will complete field note entries directly following the conclusion of each interview or data coding session (see Appendix V). The participant's involvement in the study will end at the conclusion of the interview session. |
||||
| 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 | Participants will consist of 6-12-year-old patients currently on therapy for a primary diagnosis of a leukemia/lymphoma or solid tumor at St. Jude Children's Research Hospital in Memphis, Tennessee. Potential participants will be recruited via a medical chart review performed by the principal investigator in order to identify children who have been on active therapy for a malignancy for 6 months (plus or minus 2 months) at the time of enrollment on this protocol |
||||
| Condition ICMJE |
|
||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) |
|
||||
| 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 | Recruiting | ||||
| Estimated Enrollment ICMJE | 50 | ||||
| Estimated Completion Date | September 2013 | ||||
| Estimated Primary Completion Date | June 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
| Gender | Both | ||||
| Ages | 6 Years to 12 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
|
||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01383473 | ||||
| Other Study ID Numbers ICMJE | SCHOOL1 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | St. Jude Children's Research Hospital | ||||
| Study Sponsor ICMJE | St. Jude Children's Research Hospital | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | St. Jude Children's Research Hospital | ||||
| Verification Date | February 2013 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||