LeukemiaNCT01383473
Concurrent School Attendance And Cancer Therapy: The Experiences of 6-12 Year Old Pediatric Oncology Patients
An observational study of Leukemia and Lymphoma, run by St. Jude Children's Research Hospital at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Leukemia, Lymphoma, Solid Tumor
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to Jul 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
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
Who may be able to join
- Participant is 6-12 years of age at the time of diagnosis.
- Participant has a primary diagnosis of leukemia/lymphoma or solid tumor.
- Participant has been on therapy for six months (plus or minus 2 months) at the time of enrollment on this protocol.
- Participant is able to read and speak English.
Who cannot join
- Participant has not received any type of schooling services either in the home, community, or hospital setting since diagnosis.
- Participant did not receive any type of schooling services prior to diagnosis.
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
About this study
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.
Read the 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.
- Conditions
- Leukemia, Lymphoma, Solid Tumor
- Keywords
- cancer therapy, school attendance, cancer diagnosis, perception
- Medical subject headings
- Leukemia, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Leukemia Patients | 6-12 year old pediatric oncology patients' perceptions of their school experiences pre and post cancer diagnosis will be done through interviews and drawings. | |
| Solid Tumor Patients | 6-12 year old pediatric oncology patients' perceptions of their school experiences pre and post cancer diagnosis will be done through interviews and drawings. |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-12 year old pediatric oncology patients' perceptions of their school experiences pre and post cancer diagnosis will be explored;
This will be done through interviews and drawings.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2011 (estimated)
- Study startAug 2011
- Primary completionJun 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- More trials run by St. Jude Children's Research HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jessika C Boles, MEd., CCLS, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01383473
- Sponsor's protocol ID
- SCHOOL1
- Status last verified
- Aug 2013
- First submitted
- 27 Jun 2011
- Last updated
- 27 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Concurrent School Attendance And Cancer Therapy: The Experiences of 6-12 Year Old Pediatric Oncology Patients
- ClinicalTrials.gov ID
- NCT01383473
- Acronym / sponsor ID
- SCHOOL1
- Conditions
- Leukemia, Lymphoma, Solid Tumor
- Keywords
- cancer therapy, school attendance, cancer diagnosis, perception
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 28 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Leukemia Patients | – | –6-12 year old pediatric oncology patients' perceptions of their school experiences pre and post cancer diagnosis will be done through interviews and drawings. |
| Solid Tumor Patients | – | –6-12 year old pediatric oncology patients' perceptions of their school experiences pre and post cancer diagnosis will be done through interviews and drawings. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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
Key inclusion criteria (4 listed)
- Participant is 6-12 years of age at the time of diagnosis.
- Participant has a primary diagnosis of leukemia/lymphoma or solid tumor.
- Participant has been on therapy for six months (plus or minus 2 months) at the time of enrollment on this protocol.
- Participant is able to read and speak English.
Key exclusion criteria (2 listed)
- Participant has not received any type of schooling services either in the home, community, or hospital setting since diagnosis.
- Participant did not receive any type of schooling services prior to diagnosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
6-12 year old pediatric oncology patients' perceptions of their school experiences pre and post cancer diagnosis will be explored;
Time frame: 1 year
This will be done through interviews and drawings.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2015.
- St. Jude Children's Research HospitalLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jessika C Boles, MEd., CCLS principal investigator
St. Jude Children's Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Leukemia and Lymphoma, run by St. Jude Children's Research Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-12 year old pediatric oncology patients' perceptions of their school experiences pre and post cancer diagnosis will be explored; (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2015.