NCT02114827

Brief 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).

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2014

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

April 3, 2014

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 15, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

July 21, 2015

Status Verified

July 1, 2015

Enrollment Period

1.2 years

First QC Date

April 3, 2014

Last Update Submit

July 17, 2015

Conditions

Leukemia, Not Otherwise SpecifiedMalignant Neoplasm

Keywords

Multiple Myeloma

Outcome Measures

Primary Outcomes (2)

  • Change in emergency department visits

    Data will be collected through review of medical and insurance billing records

    Up to 12 months after HSCT

  • Change in number of hospitalizations

    Data will be collected through review of medical and insurance billing records

    Up to 12 months after HSCT

Secondary Outcomes (1)

  • Perception of satisfaction with the physician consultation

    Up to 12 months after HSCT

Study Arms (2)

Video

EXPERIMENTAL

Patients will view the 23-minute "Guide to Stem Cell Transplantation" video depicting the HSCT experience

Behavioral: Video

FAQ Sheet

ACTIVE COMPARATOR

Patients will receive HSCT FAQ sheet developed by the NCI at the NIH

Behavioral: FAQ Sheet

Interventions

VideoBEHAVIORAL

23-minute video

Also known as: Guide to Stem Cell Transplantation
Video
FAQ SheetBEHAVIORAL
Also known as: HSCT Freuently asked questions sheet developed by NCI at NIH
FAQ Sheet

Eligibility Criteria

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

You may qualify if:

  • Cancer patients scheduled for HSCT

You may not qualify if:

  • Patients who have received HSCT previously
  • Patients who do not speak English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

LeukemiaNeoplasmsMultiple Myeloma

Interventions

Videotape Recording

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeHematologic DiseasesHemic and Lymphatic DiseasesNeoplasms, Plasma CellHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Tape RecordingAudiovisual AidsEducational TechnologyTechnologyTechnology, Industry, and AgricultureTelevision

Study Officials

  • Robin K Matsuyama, PhD

    Virginia Commonwealth University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 3, 2014

First Posted

April 15, 2014

Study Start

April 1, 2014

Primary Completion

June 1, 2015

Study Completion

July 1, 2015

Last Updated

July 21, 2015

Record last verified: 2015-07

Locations

US(1)