Leukemia, Not Otherwise SpecifiedNCT02114827
Efficacy of a Patient Education Video
A study testing Video and FAQ Sheet in people with Leukemia, Not Otherwise Specified and Malignant Neoplasm, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
Patients in the intervention arm will view the 23-minute video depicting the Hematopoietic stem cell transplantation (HSCT) experience. Patients in the control arm will receive HSCT frequently asked questions (FAQ) sheet developed by the National Cancer Institute (NCI) at the National Institutes of Health (NIH). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukemia, Not Otherwise Specified, Malignant Neoplasm
- What is being tested?
- Video and FAQ Sheet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to Jul 2015
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cancer patients scheduled for HSCT
Who cannot join
- Patients who have received HSCT previously
- Patients who do not speak English
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
Patients in the intervention arm will view the 23-minute video depicting the Hematopoietic stem cell transplantation (HSCT) experience. Patients in the control arm will receive HSCT frequently asked questions (FAQ) sheet developed by the National Cancer Institute (NCI) at the National Institutes of Health (NIH).
Read the detailed description
The study's overall goals are 1) to improve outcomes; and 2) to increase satisfaction with the physician consultation.
Patients will be randomized to intervention or control and data will be collected at three time points (before treatment, 30 days post-HSCT and 12 months post-HSCT).
- Being tested
- Video, FAQ Sheet
- Keywords
- Multiple Myeloma
- Medical subject headings
- Leukemia, Neoplasms, Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VideoBehavioural
Also called Guide to Stem Cell Transplantation
23-minute video
FAQ SheetBehavioural
Also called HSCT Freuently asked questions sheet developed by NCI at NIH
| Study group | Role | What they receive |
|---|---|---|
| Video | Experimental | Patients will view the 23-minute "Guide to Stem Cell Transplantation" video depicting the HSCT experience Receives: Behavioral: Video |
| FAQ Sheet | Active comparator | Patients will receive HSCT FAQ sheet developed by the NCI at the NIH Receives: Behavioral: FAQ Sheet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in emergency department visits
Data will be collected through review of medical and insurance billing records
Measured: Up to 12 months after HSCT
Change in number of hospitalizations
Data will be collected through review of medical and insurance billing records
Measured: Up to 12 months after HSCT
Secondary outcomes (1)
Perception of satisfaction with the physician consultation
The Physician consultation will be measured by the Patient Satisfaction Communication Questionnaire (PSCQA). Participants are asked to rate their experience with the physician consultation. There are 17 items, 8 positively worded and 9 negatively worded. Each item is rated on a 5 point likert scale with 1 being strongly agree to 5 being strongly disagree. The maximum score on the PSCQ is 85. The measure takes approximately 4 minutes to administer.
Measured: Up to 12 months after HSCT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionJun 2015
- Study completionJul 2015
Why it stopped: study closed due to slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leukemia, Not Otherwise SpecifiedStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robin K Matsuyama, PhD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02114827
- Sponsor's protocol ID
- MCC-13-10228
- Other IDs
- HM20000410
- Status last verified
- Jul 2015
- First submitted
- 3 Apr 2014
- Last updated
- 21 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Patient Education Video
- ClinicalTrials.gov ID
- NCT02114827
- Acronym / sponsor ID
- MCC-13-10228
- Keywords
- Multiple Myeloma
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: study closed due to slow accrual
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 15 Apr 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.
Patients in the intervention arm will view the 23-minute video depicting the Hematopoietic stem cell transplantation (HSCT) experience. Patients in the control arm will receive HSCT frequently asked questions (FAQ) sheet developed by the National Cancer Institute (NCI) at the National Institutes of Health (NIH).
Detailed description
The study's overall goals are 1) to improve outcomes; and 2) to increase satisfaction with the physician consultation.
Patients will be randomized to intervention or control and data will be collected at three time points (before treatment, 30 days post-HSCT and 12 months post-HSCT).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Video | Experimental | Behavioral: VideoPatients will view the 23-minute "Guide to Stem Cell Transplantation" video depicting the HSCT experience |
| FAQ Sheet | Active comparator | Behavioral: FAQ SheetPatients will receive HSCT FAQ sheet developed by the NCI at the NIH |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Cancer patients scheduled for HSCT
Key exclusion criteria (2 listed)
- Patients who have received HSCT previously
- Patients who do not speak English
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 |
|---|---|---|
| VideoAlso: Guide to Stem Cell Transplantation23-minute video | Behavioural | Video |
| FAQ SheetAlso: HSCT Freuently asked questions sheet developed by NCI at NIH | Behavioural | FAQ Sheet |
Primary outcome
Change in emergency department visits
Time frame: Up to 12 months after HSCT
Data will be collected through review of medical and insurance billing records
Change in number of hospitalizations
Time frame: Up to 12 months after HSCT
Data will be collected through review of medical and insurance billing records
1 secondary outcome
Perception of satisfaction with the physician consultation
Time frame: Up to 12 months after HSCT
Results and safety
The study was stopped early (reason given: study closed due to slow accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 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.
Robin K Matsuyama, PhD principal investigator
Virginia Commonwealth University
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 and FAQ Sheet in people with Leukemia, Not Otherwise Specified and Malignant Neoplasm, run by Virginia Commonwealth University 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 1 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: stopped early, as of the sponsor's last update on 21 Jul 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 was stopped early (reason given: study closed due to slow accrual). Results are not available in the source record.
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?
Change in emergency department visits (time frame: Up to 12 months after HSCT). The study lists 2 primary outcomes in all. 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 21 Jul 2015.