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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02642510
Other study ID # IRB00073387
Secondary ID
Status Completed
Phase N/A
First received December 27, 2015
Last updated June 21, 2017
Start date June 2014
Est. completion date February 20, 2017

Study information

Verified date June 2017
Source Emory University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. Outcome variables will be the patient and family member's satisfaction with inpatient teaching and anxiety about inpatient treatment.


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.


Recruitment information / eligibility

Status Completed
Enrollment 78
Est. completion date February 20, 2017
Est. primary completion date February 20, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Structured Education DVD + Verbal Teaching
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 Teaching
Participants will receive verbal educational teaching by their assigned nursing staff regarding information about leukemia and lymphoma, common treatments, and side effects.

Locations

Country Name City State
United States Emory University Hospital Atlanta Georgia

Sponsors (1)

Lead Sponsor Collaborator
Emory University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Post Educational Teaching (Up to 30 minutes)
Secondary 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. Post Educational Teaching (Up to 30 minutes)
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