NCT02642510

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P50-P75 for not_applicable leukemia

Timeline
Completed

Started Jun 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

December 27, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 30, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2017

Completed
Last Updated

June 22, 2017

Status Verified

June 1, 2017

Enrollment Period

2.7 years

First QC Date

December 27, 2015

Last Update Submit

June 21, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Visual analog scale (VAS) Score

    Post Educational Teaching (Up to 30 minutes)

Study Arms (2)

DVD Structured Education

EXPERIMENTAL

Participants in this group will watch an educational DVD in addition to standard teaching by nursing staff.

Other: Structured Education DVD + Verbal TeachingOther: Verbal Teaching

Standard Educational Teaching

ACTIVE COMPARATOR

Participants in this group will receive educational teaching by their assigned nursing staff.

Other: Verbal Teaching

Interventions

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.

DVD Structured Education

Participants will receive verbal educational teaching by their assigned nursing staff regarding information about leukemia and lymphoma, common treatments, and side effects.

DVD Structured EducationStandard Educational Teaching

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +2 more criteria

You may not qualify if:

  • At end of life
  • Altered mental status
  • Significant auditory or visual deficits with corrective devices

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

LeukemiaLymphoma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Christina Peters, NP

    Emory University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Advanced Practitioner

Study Record Dates

First Submitted

December 27, 2015

First Posted

December 30, 2015

Study Start

June 1, 2014

Primary Completion

February 20, 2017

Study Completion

February 20, 2017

Last Updated

June 22, 2017

Record last verified: 2017-06

Locations