- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02642510
Improving Patient Education for Lymphoma and Leukemia Inpatients
Improving Patient Education for Newly Diagnosed Lymphoma and Acute Leukemia Inpatients
Study Overview
Status
Intervention / 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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Georgia
-
Atlanta, Georgia, United States, 30322
- Emory University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
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
- 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
Exclusion Criteria:
- At end of life
- Altered mental status
- Significant auditory or visual deficits with corrective devices
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: DVD Structured Education
Participants in this group will watch an educational DVD in addition to standard teaching by nursing staff.
|
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.
Participants will receive verbal educational teaching by their assigned nursing staff regarding information about leukemia and lymphoma, common treatments, and side effects.
|
|
Active Comparator: Standard Educational Teaching
Participants in this group will receive educational teaching by their assigned nursing staff.
|
Participants will receive verbal educational teaching by their assigned nursing staff regarding information about leukemia and lymphoma, common treatments, and side effects.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Post Educational Teaching (Up to 30 minutes)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual analog scale (VAS) Score
Time Frame: Post Educational Teaching (Up to 30 minutes)
|
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.
|
Post Educational Teaching (Up to 30 minutes)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Christina Peters, NP, Emory University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00073387
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.