NCT02378012

Brief Summary

This randomized clinical trial studies iPad use in reducing anxiety and depression in patients undergoing bone marrow transplant. A tablet device like the iPad can provide access to music, television, movies, books, and the Internet. It also contains a video conferencing system that can allow patients to communicate with family members and other members of their social support team. With these capabilities, an iPad distribution program may help lessen patient anxiety and depression during a hospital stay. Monitoring iPad use by patients may help doctors better understand how patients use their computers and tablets while in the hospital so that the software and applications of the iPad can be made more useful.

Trial Health

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Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for not_applicable anxiety

Timeline
Completed

Started Mar 2014

Shorter than P25 for not_applicable anxiety

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

March 19, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 6, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 6, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 26, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 4, 2015

Completed
Last Updated

June 24, 2020

Status Verified

June 1, 2020

Enrollment Period

6 months

First QC Date

February 26, 2015

Last Update Submit

June 22, 2020

Conditions

AnxietyDepressionMalignant Neoplasm

Outcome Measures

Primary Outcomes (1)

  • Change in Hospital Anxiety and Depression Scale (HADS)-Anxiety score

    Will be analyzed using an analysis of covariance (ANCOVA) model containing fixed effects of treatment condition (iPAD vs. no iPAD), baseline HADS-Anxiety score, and a random, normally distributed error term. The data will be log-transformed prior to analysis, so all resulting inferences will be based on the geometric mean instead of the arithmetic mean.

    Baseline to day 10

Secondary Outcomes (2)

  • Change in HADS depression score

    Baseline to day 10

  • Change in Profile of Mood States Short Form (POMS-SF) scores

    Baseline to day 10

Study Arms (3)

GROUP A (participants provide own computer or tablet device)

ACTIVE COMPARATOR

A member of the research personnel helps the participants install Netflix, Spotify, and Skype applications on their computers if they wish to do so. Participants will be given subscriptions to each application and usernames for access on days -5 to 10.

Other: Computer-Assisted InterventionOther: Questionnaire Administration

GROUP B (Apple BuckiPad)

EXPERIMENTAL

Participants receive an iPad for days -5 to 10. Participants also receive the BuckiPad manual for instructions on how to use the iPad and Netflix, Skype, and Spotify applications. Participants are also directed to the official Apple's iPad user's manual on their device and have questions answered by research personnel on day -5.

Other: Computer-Assisted InterventionOther: Questionnaire Administration

GROUP C (no intervention)

NO INTERVENTION

Participants do not receive an iPad for days -5 to 10.

Interventions

Computer-Assisted InterventionOTHER

Receive access to Netflix, Spotify, and Skype applications

GROUP A (participants provide own computer or tablet device)GROUP B (Apple BuckiPad)
Questionnaire AdministrationOTHER

Ancillary studies

GROUP A (participants provide own computer or tablet device)GROUP B (Apple BuckiPad)

Eligibility Criteria

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

You may qualify if:

  • Adult patients undergoing treatment in the bone marrow transplant (BMT) unit on the 3rd floor of the James Cancer Hospital and Solove Research Institute
  • Patients receiving reduced intensity chemotherapy for an allogeneic stem cell transplant

You may not qualify if:

  • Patients who lack the visual or motor skills necessary to use a tablet device like the Apple iPad
  • Criteria for visual proficiency will be determined by asking the patient: do you have trouble reading a newspaper even with your glasses or contacts (if you wear them); if "yes", they will be excluded
  • Criteria for motor skill proficiency will be determined by asking the patient: do you have any trouble using a television remote control; if "yes", they will be excluded
  • Patients who do not speak English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

Related Links

MeSH Terms

Conditions

Anxiety DisordersDepressionNeoplasms

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehavior

Study Officials

  • Samantha Jaglowski

    Ohio State University Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 26, 2015

First Posted

March 4, 2015

Study Start

March 19, 2014

Primary Completion

September 6, 2014

Study Completion

September 6, 2014

Last Updated

June 24, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)