Efficacy of a Patient Education Video

Malignant Neoplasm Clinical Trial

Official title:

Efficacy of a Patient Education Video

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02114827
• Other study ID #: MCC-13-10228
• Secondary ID: HM20000410
• Status: Terminated
• Phase: N/A
• First received: April 3, 2014
• Last updated: July 17, 2015
• Start date: April 2014
• Est. completion date: July 2015

Study information

• Verified date: July 2015
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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).

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: July 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Cancer patients scheduled for HSCT

Exclusion Criteria:

• Patients who have received HSCT previously

• Patients who do not speak English

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Leukemia, Not Otherwise Specified
• Malignant Neoplasm
• Neoplasms

Intervention

Behavioral:
• Video
23-minute video
• FAQ Sheet

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in emergency department visits	Data will be collected through review of medical and insurance billing records	Up to 12 months after HSCT	No
Primary	Change in number of hospitalizations	Data will be collected through review of medical and insurance billing records	Up to 12 months after HSCT	No
Secondary	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.	Up to 12 months after HSCT	No