LeukemiaNCT02642510
Improving Patient Education for Lymphoma and Leukemia Inpatients
A study testing Structured Education DVD + Verbal Teaching and Verbal Teaching in people with Leukemia and Lymphoma, run by Emory University at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the impact of a structured, DVD educational intervention about what to expect during inpatient treatment of a newly diagnosed cancer. The focus of the study will be newly diagnosed lymphoma and acute leukemia patients and their family members. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Structured Education DVD + Verbal Teaching and Verbal Teaching
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to 20 Feb 2017
- 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
- For participants admitted for suspect diagnosis of leukemia or lymphoma:
- Admission to the hematology/leukemia unit (6E) at Emory University Hospital with a suspected or actual new diagnosis of leukemia or lymphoma within the past 24 hours
- English-speaking
- Completed education to at least the 6th grade level
- No significant auditory or visual deficits with corrective devices
- No central nervous system involvement of disease
Show all 17Show fewer
- Physiologically stable
- Not at end of life
- No alterations in mental status
- Agrees to family member (family member; significant other; friend) participation in study and to selecting the individual who could participate
- For Family Members:
- Willing to view DVD and read education booklet
- Selected by patient to participate
- English speaking
- No significant auditory or visual deficits with corrective devices
- No alterations in mental status
- Completed education to at least the 6th grade level
Who cannot join
- At end of life
- Altered mental status
- Significant auditory or visual deficits with corrective devices
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improving Patient Education for Newly Diagnosed Lymphoma and Acute Leukemia Inpatients
The purpose of this study is to evaluate the impact of a structured, DVD educational intervention about what to expect during inpatient treatment of a newly diagnosed cancer. The focus of the study will be newly diagnosed lymphoma and acute leukemia patients and their family members. Outcome variables will be the patient and family member's satisfaction with inpatient teaching and anxiety about inpatient treatment.
Read the detailed description
The purpose of this study is to evaluate the impact of a structured, DVD educational intervention about what to expect during inpatient treatment of a newly diagnosed cancer. The focus of the study will be newly diagnosed lymphoma and acute leukemia patients and their family members. Outcome variables will be the patient and family member's satisfaction with inpatient teaching and anxiety about inpatient treatment.
The experimental group will watch a DVD educational presentation of information about unit routines and activities; leukemia/lymphoma; treatment modalities and procedures; treatment of side effects; and patient and family members activities of importance to prevent infection and promote well-being during cancer treatment.
Participants in the control group will receive usual educational teaching by their assigned nursing staff.
- Being tested
- Structured Education DVD + Verbal Teaching, Verbal Teaching
- Medical subject headings
- Leukemia, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured Education DVD + Verbal TeachingOther
The structured education DVD is a 15-minute DVD presentation of information about unit routines and activities; leukemia/lymphoma; treatment modalities and procedures; treatment of side effects; and participant and family members activities of importance to prevent infection and promote well-being during cancer treatment.
Participants will also receive verbal educational teaching by their assigned nursing staff regarding information about leukemia and lymphoma, common treatments, and side effects.
Verbal TeachingOther
Participants will receive verbal educational teaching by their assigned nursing staff regarding information about leukemia and lymphoma, common treatments, and side effects.
| Study group | Role | What they receive |
|---|---|---|
| DVD Structured Education | Experimental | Participants in this group will watch an educational DVD in addition to standard teaching by nursing staff. Receives: Other: Structured Education DVD + Verbal Teaching; Other: Verbal Teaching |
| Standard Educational Teaching | Active comparator | Participants in this group will receive educational teaching by their assigned nursing staff. Receives: Other: Verbal Teaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Discharge Teaching Scale (QDTS) Score
Overall satisfaction will be measured with the Quality of Discharge Teaching Scale (QDTS).The QDTS is a 24 item survey to evaluate all of the teaching received by patients during their hospitalization prior to discharge. Each item on the survey is rated on a 0 to 10 numeric scale, with 0 representing an item was not addressed and 10 representing an item addressed a great deal. For each aspect of education or information being evaluated, participant are asked to rate the content of the education, as well as the delivery of the content.
Measured: Post Educational Teaching (Up to 30 minutes)
Secondary outcomes (1)
Visual analog scale (VAS) Score
Participants are instructed to place a horizontal mark across the 100 mm vertical line anchored at one end with the words "No Anxiety" and at the other end "Worst Anxiety Imaginable" at the level of their anxiety about inpatient cancer treatment. Rating of anxiety for the study will be done by having the participant mark their anxiety level on a new, unmarked VAS. Scoring of the VAS is done by measuring in millimeters from the end of the vertical line with the anchor phrases of "no anxiety" to the intersection of the participant's mark on the vertical line. Possible scores on the VAS range from 0 to 100 millimeters with higher scores indicating higher levels of anxiety.
Measured: Post Educational Teaching (Up to 30 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2015 (estimated)
- Study startJun 2014
- Primary completion20 Feb 2017
- Study completion20 Feb 2017
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 Emory 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
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christina Peters, Emory University
- Investigators
- Christina Peters, NP, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02642510
- Sponsor's protocol ID
- IRB00073387
- Status last verified
- Jun 2017
- First submitted
- 27 Dec 2015
- Last updated
- 22 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Patient Education for Newly Diagnosed Lymphoma and Acute Leukemia Inpatients
- ClinicalTrials.gov ID
- NCT02642510
- Acronym / sponsor ID
- IRB00073387
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- 20 Feb 2017 (actual)
- Study completion
- 20 Feb 2017 (actual)
- First posted
- 30 Dec 2015 (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.
The purpose of this study is to evaluate the impact of a structured, DVD educational intervention about what to expect during inpatient treatment of a newly diagnosed cancer. The focus of the study will be newly diagnosed lymphoma and acute leukemia patients and their family members. Outcome variables will be the patient and family member's satisfaction with inpatient teaching and anxiety about inpatient treatment.
Detailed description
The purpose of this study is to evaluate the impact of a structured, DVD educational intervention about what to expect during inpatient treatment of a newly diagnosed cancer. The focus of the study will be newly diagnosed lymphoma and acute leukemia patients and their family members. Outcome variables will be the patient and family member's satisfaction with inpatient teaching and anxiety about inpatient treatment.
The experimental group will watch a DVD educational presentation of information about unit routines and activities; leukemia/lymphoma; treatment modalities and procedures; treatment of side effects; and patient and family members activities of importance to prevent infection and promote well-being during cancer treatment.
Participants in the control group will receive usual educational teaching by their assigned nursing staff.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DVD Structured Education | Experimental | Other: Structured Education DVD + Verbal Teaching, Other: Verbal TeachingParticipants in this group will watch an educational DVD in addition to standard teaching by nursing staff. |
| Standard Educational Teaching | Active comparator | Other: Verbal TeachingParticipants in this group will receive educational teaching by their assigned nursing staff. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Admission to the hematology/leukemia unit (6E) at Emory University Hospital with a suspected or actual new diagnosis of leukemia or lymphoma within the past 24 hours
- English-speaking
- Completed education to at least the 6th grade level
- No significant auditory or visual deficits with corrective devices
- No central nervous system involvement of disease
Key exclusion criteria (3 listed)
- At end of life
- Altered mental status
- Significant auditory or visual deficits with corrective devices
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 |
|---|---|---|
| Structured Education DVD + Verbal TeachingThe structured education DVD is a 15-minute DVD presentation of information about unit routines and activities; leukemia/lymphoma; treatment modalities and procedures; treatment of side effects; and participant and family members activities of importance to prevent infection and promote well-being during cancer treatment. Participants will also receive verbal educational teaching by their assigned nursing staff regarding information about leukemia and lymphoma, common treatments, and side effects. | Other | DVD Structured Education |
| Verbal TeachingParticipants will receive verbal educational teaching by their assigned nursing staff regarding information about leukemia and lymphoma, common treatments, and side effects. | Other | DVD Structured Education, Standard Educational Teaching |
Primary outcome
Quality of Discharge Teaching Scale (QDTS) Score
Time frame: Post Educational Teaching (Up to 30 minutes)
Overall satisfaction will be measured with the Quality of Discharge Teaching Scale (QDTS).The QDTS is a 24 item survey to evaluate all of the teaching received by patients during their hospitalization prior to discharge. Each item on the survey is rated on a 0 to 10 numeric scale, with 0 representing an item was not addressed and 10 representing an item addressed a great deal. For each aspect of education or information being evaluated, participant are asked to rate the content of the education, as well as the delivery of the content.
1 secondary outcome
Visual analog scale (VAS) Score
Time frame: Post Educational Teaching (Up to 30 minutes)
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 22 Jun 2017.
Related trials for Leukemia
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 1
A Study of CHM-029 in Participants With NPM1 Mutated, KMT2A or NUP98 Rearranged AML
AML (Acute Myeloid Leukemia)
RecruitingPhase 1
Vididencel in CML-CP Patients With MRD
CML (Chronic Myelogenous Leukemia)
RecruitingPhase 2
Testing New Therapies for Patients With Acute Myeloid Leukemia Who Are Newly Diagnosed and Have Not Yet Started Treatment (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm
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.
Christina Peters, NP principal investigator
Emory 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 Structured Education DVD + Verbal Teaching and Verbal Teaching in people with Leukemia and Lymphoma, run by Emory 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 17 inclusion and 3 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 22 Jun 2017. 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?
Quality of Discharge Teaching Scale (QDTS) Score (time frame: Post Educational Teaching (Up to 30 minutes)). 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 22 Jun 2017.