SarcomaNCT02041689
A Qualitative Case Study of the Experiences of Children With Cancer as They Learn About Their Diagnosis and Treatment
An observational study of Sarcoma, run by St. Jude Children's Research Hospital at 1 site in United States.
Trial summary
Thousands of children are diagnosed with cancer each year, many of whom will achieve long term survival due to advances in treatments and technologies. However, when a child is first diagnosed, they are confronted with a wealth of new and unfamiliar medical information that they must integrate in order to understand… Read more about this study
- Who is it for?
- Ages 7 to 11 years
- Conditions the study is for
- Sarcoma
- What is being tested?
- Interview, Observations and Guided Activities
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Oct 2015
- 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 7 to 11 years
- All sexes
- No healthy volunteers
- Child
Study population: Participants will be patients at St. Jude Children's Research Hospital.
Who may be able to join
- The child is between the ages of 7 and 11 years on the day of their initial arrival to the hospital
- The child has a working diagnosis or initial diagnosis of a bone or soft tissue sarcoma that will require multimodal therapy to include chemotherapy, plus or minus surgical resection, plus or minus radiation therapy.
- Both the child and parents speak English as their primary language
- Parents are willing to give consent and child is willing to give assent
Who cannot join
- The child has a pre-existing, documented learning disability or cognitive impairment and has previously received learning accommodations under an individualized education plan (IEP).
- The child has a pre-existing, documented diagnosis of autism spectrum disorder (including autism and Asperger's disorder).
- Child has previously received treatment for a cancer diagnosis either at St. Jude or another institution.
- Parent and/or child are unwilling or unable to give consent/assent.
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
About this study
Thousands of children are diagnosed with cancer each year, many of whom will achieve long term survival due to advances in treatments and technologies. However, when a child is first diagnosed, they are confronted with a wealth of new and unfamiliar medical information that they must integrate in order to understand their diagnosis and treatment plan. Little is yet known about how children with cancer experience learning about their diagnosis and treatment in the hospital setting, or the individuals and materials that may help to facilitate the child's developing understanding. This information could help to identify or guide educational and supportive child life interventions to help children with cancer better understand their illness and its treatment.
This observational study will collect data about how children currently learn about their cancer diagnosis and treatment in the hospital setting. The interventions used do not seek to change the health outcomes of the participants in this study. The observational data collected may serve to improve how future patients learn about their cancer-related diagnosis.
Read the detailed description
This is a longitudinal qualitative case study, and no randomized interventions will be used. Instead, participants will complete two interview sessions, three guided activities, and observations with the primary investigator to explore their experiences of learning about their diagnosis and treatment in the hospital setting.
PRIMARY OBJECTIVE:
- The primary objective of this qualitative case study is to describe the ways in which children with cancer learn about their cancer diagnosis and treatment in the hospital setting.
- Conditions
- Sarcoma
- Being tested
- Interview, Observations, Guided Activities
- Keywords
- Children, Cancer, Learning, Education, Qualitative
- Medical subject headings
- Sarcoma, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterviewBehavioural
Each participant will complete two interview sessions with the primary investigator. Each interview will be conducted in a private, quiet room. Parents may choose to remain with the child during the interview if they would like, but only the responses of the child will be analyzed. Each interview session will last no more than one hour; if the child is not able to respond to each of the primary interview questions during this time, a second follow-up session will be scheduled so that the remainder of the questions can be answered. All interviews will be audio-recorded and transcribed.
ObservationsBehavioural
Observations help to give insights about interpersonal interactions, actions, non-verbal cues, and the activities and function of areas within the hospital. Three kinds of observation will be used: participant observation, non-participant observation, and guided activities. These observations will be conducted to learn more about the hospital environment as it intersects with the learning experiences of the participants.
Guided ActivitiesBehavioural
This study will use three different types of arts and play-based activities to give participants a variety of ways to express their thoughts and perceptions of what it is like to learn about their cancer diagnosis and treatment.
The first activity will be a guided medical play opportunity that prompts the child to use actual medical equipment while taking care of a doll.
For the second activity, the child will be given a digital camera to use and a prompt that asks them to photograph things and individuals in the hospital that have helped them to learn about their diagnosis and treatment.
The third activity will be an open-ended art prompt in which the child will create an artistic representation of what it means to have cancer and get treatment.
| Study group | Role | What they receive |
|---|---|---|
| Participants | Patients at St. Jude Children's Research Hospital between the ages of 7 and 11 years who have a working diagnosis or initial diagnosis of a bone or soft tissue sarcoma.
Interventions: two unstructured life-story interview sessions, observations, and guided activities. Receives: Behavioral: Interview; Behavioral: Observations; Behavioral: Guided Activities |
What is being measured
The primary outcome is the main question the study is designed to answer.
Case study of the ways in which children with cancer learn about their diagnosis and treatment in the hospital setting
Data will be collected during individual interviews, guided activity sessions, and observations of participant clinic appointments, inpatient admissions, and other medical events. Because there are no hypotheses to be tested or evaluated, and because this is a qualitative study, no statistical analyses will be used. Instead, coding and categorizing techniques will be used as are common in multiple case study designs. Data analysis in this study will occur constantly and simultaneously alongside data collection and interpretation. Data sources will be analyzed between and within participants using multiple case study analysis. Contextualizing analysis will be used to construct a thematic analysis.
Measured: Observations collected from diagnosis through 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcomaStudies 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
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jessika Boles, MEd, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02041689
- Sponsor's protocol ID
- CASELEARN
- Status last verified
- Jan 2016
- First submitted
- 16 Jan 2014
- Last updated
- 20 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Qualitative Case Study of the Experiences of Children With Cancer as They Learn About Their Diagnosis and Treatment
- ClinicalTrials.gov ID
- NCT02041689
- Acronym / sponsor ID
- CASELEARN
- Conditions
- Sarcoma
- Keywords
- Children, Cancer, Learning, Education, Qualitative
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 22 Jan 2014 (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.
Thousands of children are diagnosed with cancer each year, many of whom will achieve long term survival due to advances in treatments and technologies. However, when a child is first diagnosed, they are confronted with a wealth of new and unfamiliar medical information that they must integrate in order to understand their diagnosis and treatment plan. Little is yet known about how children with cancer experience learning about their diagnosis and treatment in the hospital setting, or the individuals and materials that may help to facilitate the child's developing understanding. This information could help to identify or guide educational and supportive child life interventions to help children with cancer better understand their illness and its treatment.
This observational study will collect data about how children currently learn about their cancer diagnosis and treatment in the hospital setting. The interventions used do not seek to change the health outcomes of the participants in this study. The observational data collected may serve to improve how future patients learn about their cancer-related diagnosis.
Detailed description
This is a longitudinal qualitative case study, and no randomized interventions will be used. Instead, participants will complete two interview sessions, three guided activities, and observations with the primary investigator to explore their experiences of learning about their diagnosis and treatment in the hospital setting.
PRIMARY OBJECTIVE:
- The primary objective of this qualitative case study is to describe the ways in which children with cancer learn about their cancer diagnosis and treatment in the hospital setting.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants | – | Behavioral: Interview, Behavioral: Observations, Behavioral: Guided ActivitiesPatients at St. Jude Children's Research Hospital between the ages of 7 and 11 years who have a working diagnosis or initial diagnosis of a bone or soft tissue sarcoma. Interventions: two unstructured life-story interview sessions, observations, and guided activities. |
Who may qualify
- Ages
- 7 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Participants will be patients at St. Jude Children's Research Hospital.
Key inclusion criteria (4 listed)
- The child is between the ages of 7 and 11 years on the day of their initial arrival to the hospital
- The child has a working diagnosis or initial diagnosis of a bone or soft tissue sarcoma that will require multimodal therapy to include chemotherapy, plus or minus surgical resection, plus or minus radiation therapy.
- Both the child and parents speak English as their primary language
- Parents are willing to give consent and child is willing to give assent
Key exclusion criteria (4 listed)
- The child has a pre-existing, documented learning disability or cognitive impairment and has previously received learning accommodations under an individualized education plan (IEP).
- The child has a pre-existing, documented diagnosis of autism spectrum disorder (including autism and Asperger's disorder).
- Child has previously received treatment for a cancer diagnosis either at St. Jude or another institution.
- Parent and/or child are unwilling or unable to give consent/assent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InterviewEach participant will complete two interview sessions with the primary investigator. Each interview will be conducted in a private, quiet room. Parents may choose to remain with the child during the interview if they would like, but only the responses of the child will be analyzed. Each interview session will last no more than one hour; if the child is not able to respond to each of the primary interview questions during this time, a second follow-up session will be scheduled so that the remainder of the questions can be answered. All interviews will be audio-recorded and transcribed. | Behavioural | Participants |
| ObservationsObservations help to give insights about interpersonal interactions, actions, non-verbal cues, and the activities and function of areas within the hospital. Three kinds of observation will be used: participant observation, non-participant observation, and guided activities. These observations will be conducted to learn more about the hospital environment as it intersects with the learning experiences of the participants. | Behavioural | Participants |
| Guided ActivitiesThis study will use three different types of arts and play-based activities to give participants a variety of ways to express their thoughts and perceptions of what it is like to learn about their cancer diagnosis and treatment. The first activity will be a guided medical play opportunity that prompts the child to use actual medical equipment while taking care of a doll. For the second activity, the child will be given a digital camera to use and a prompt that asks them to photograph things and individuals in the hospital that have helped them to learn about their diagnosis and treatment. The third activity will be an open-ended art prompt in which the child will create an artistic representation of what it means to have cancer and get treatment. | Behavioural | Participants |
Primary outcome
Case study of the ways in which children with cancer learn about their diagnosis and treatment in the hospital setting
Time frame: Observations collected from diagnosis through 6 months
Data will be collected during individual interviews, guided activity sessions, and observations of participant clinic appointments, inpatient admissions, and other medical events. Because there are no hypotheses to be tested or evaluated, and because this is a qualitative study, no statistical analyses will be used. Instead, coding and categorizing techniques will be used as are common in multiple case study designs. Data analysis in this study will occur constantly and simultaneously alongside data collection and interpretation. Data sources will be analyzed between and within participants using multiple case study analysis. Contextualizing analysis will be used to construct a thematic analysis.
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 20 Jan 2016.
- St. Jude Children's Research HospitalLink provided by the sponsor.
- Clinical Trials Open at St. JudeLink 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 Boles, MEd 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 Sarcoma, 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 4 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 20 Jan 2016. 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?
Case study of the ways in which children with cancer learn about their diagnosis and treatment in the hospital setting (time frame: Observations collected from diagnosis through 6 months). 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 20 Jan 2016.