CancerNCT00793299
Burden of Cancer in Children: A Pilot Study to Investigate the Impact and Content of Video Illness Narratives
A study testing Video Illness Narrative in people with Cancer, run by University of Rochester at 1 site in United States.
Trial summary
In order to gain a greater understanding of the full experience of children with life-threatening illness, this study will provide video cameras to ten to fifteen 10-18 years olds in active treatment for cancer, and instruct them to make video illness narratives over the course of 1-3 months. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Cancer
- What is being tested?
- Video Illness Narrative
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2008to Sep 2009
- Phase
- Interventional
- 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 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diagnosed with cancer
- Age 10-18
- In active treatment for cancer
- Followed at the Strong Memorial Hospital/Golisano Children's Hospital
Who cannot join
- Non-English Speaker
- Cognitively impaired so as to make data collection difficult
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Rochester School of Medicine and Dentistry, Golisano Children's Hospital at Strong
Rochester, New York, 14642
About this study
In order to gain a greater understanding of the full experience of children with life-threatening illness, this study will provide video cameras to ten to fifteen 10-18 years olds in active treatment for cancer, and instruct them to make video illness narratives over the course of 1-3 months. The narratives will be studied as an intervention; each of the participants will be administered a measure of physical symptoms (the Memorial Symptom Assessment scale 10-18) and a measure of self-esteem (the Rosenberg Self-Esteem Scale). The video narratives will also be analyzed for content by theme in order to understand the participants' experiences in their own words. Our hypothesis is that these narratives will provide insight into the lives of children with cancer, increase their self-esteem, and decrease symptom distress, and improve communication between patients and their doctors.
Read the detailed description
In addition to the above outcome measures:
The video narratives will also be analyzed for content by theme in order to understand the participants' experiences in their own words.
- Conditions
- Cancer
- Being tested
- Video Illness Narrative
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video Illness NarrativeBehavioural
video
| Study group | Role | What they receive |
|---|---|---|
| Video Illness Narrative | Experimental | single arm pilot study Receives: Behavioral: Video Illness Narrative |
What is being measured
The primary outcome is the main question the study is designed to answer.
Memorial Symptom Assessment Scale
Measured: 3 months
Secondary outcomes (1)
Rosenberg Self Esteem Scale
Measured: 3 mopnths
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2008 (estimated)
- Study startNov 2008
- Primary completionJun 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University of RochesterThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Barbara Asselin, University of Rochester
- Investigators
- Emily Hahn, BA, Principal investigator, Medical StudentBarbara Asselin, MD, Principal investigator, Associate Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00793299
- Sponsor's protocol ID
- RSRB00025699
- Status last verified
- Apr 2015
- First submitted
- 18 Nov 2008
- Last updated
- 27 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Burden of Cancer in Children: A Pilot Study to Investigate the Impact and Content of Video Illness Narratives
- ClinicalTrials.gov ID
- NCT00793299
- Acronym / sponsor ID
- RSRB00025699
- Conditions
- Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 19 Nov 2008 (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.
In order to gain a greater understanding of the full experience of children with life-threatening illness, this study will provide video cameras to ten to fifteen 10-18 years olds in active treatment for cancer, and instruct them to make video illness narratives over the course of 1-3 months. The narratives will be studied as an intervention; each of the participants will be administered a measure of physical symptoms (the Memorial Symptom Assessment scale 10-18) and a measure of self-esteem (the Rosenberg Self-Esteem Scale). The video narratives will also be analyzed for content by theme in order to understand the participants' experiences in their own words. Our hypothesis is that these narratives will provide insight into the lives of children with cancer, increase their self-esteem, and decrease symptom distress, and improve communication between patients and their doctors.
Detailed description
In addition to the above outcome measures:
The video narratives will also be analyzed for content by theme in order to understand the participants' experiences in their own words.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Video Illness Narrative | Experimental | Behavioral: Video Illness Narrativesingle arm pilot study |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Diagnosed with cancer
- Age 10-18
- In active treatment for cancer
- Followed at the Strong Memorial Hospital/Golisano Children's Hospital
Key exclusion criteria (2 listed)
- Non-English Speaker
- Cognitively impaired so as to make data collection difficult
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 |
|---|---|---|
| Video Illness Narrativevideo | Behavioural | Video Illness Narrative |
Primary outcome
Memorial Symptom Assessment Scale
Time frame: 3 months
1 secondary outcome
Rosenberg Self Esteem Scale
Time frame: 3 mopnths
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 Apr 2015.
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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.
Emily Hahn, BA principal investigator
Medical Student
Barbara Asselin, MD principal investigator
Associate Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video Illness Narrative in people with Cancer, run by University of Rochester 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 Apr 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?
Memorial Symptom Assessment Scale (time frame: 3 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 27 Apr 2015.