iPad Use in Reducing Anxiety and Depression in Patients Undergoing Bone Marrow Transplant (BUCKiPAD)

Project BUCKiPAD: The Evaluation of an iPAD Distribution Program on Anxiety and Depression in Bone and Marrow Transplant Patients

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.

Study Overview

• Status: Terminated
• Conditions: Depression; Anxiety; Malignant Neoplasm
• Intervention / Treatment: Other: Questionnaire Administration; Other: Computer-Assisted Intervention; Other: Computer-Assisted Intervention

Detailed Description

PRIMARY OBJECTIVES:

I. To evaluate the effect access to an iPad has on anxiety as measured by the Hospital Anxiety and Depression Scale.

SECONDARY OBJECTIVES:

I. Determine how computers and tablets are used by patients who have access to such devices.

OUTLINE: Participants are assigned to Group A or randomized to 1 of 2 groups (Groups B or C).

GROUP A (participants provide their own computer or tablet device): 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.

GROUP B (Apple iPad): 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.

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

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: GROUP A (participants provide own computer or tablet device); 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: Questionnaire Administration; Ancillary studies; Other: Computer-Assisted Intervention; Receive access to Netflix, Spotify, and Skype applications; Other: Computer-Assisted Intervention; Receive iPad and instruction manuals.
Experimental: GROUP B (Apple BuckiPad); 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: Questionnaire Administration; Ancillary studies; Other: Computer-Assisted Intervention; Receive access to Netflix, Spotify, and Skype applications; Other: Computer-Assisted Intervention; Receive iPad and instruction manuals.
No Intervention: GROUP C (no intervention); Participants do not receive an iPad for days -5 to 10.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in HADS depression score	Will be analyzed using an ANCOVA model containing fixed effects of treatment condition (iPAD vs. no iPAD), baseline HADS-Depression 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
Change in Profile of Mood States Short Form (POMS-SF) scores	Will be analyzed using an ANCOVA model containing fixed effects of treatment condition (iPAD vs. no iPAD), baseline POMS-SF 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

Collaborators and Investigators

• Sponsor: Ohio State University Comprehensive Cancer Center
• Investigators: Principal Investigator: Samantha Jaglowski, Ohio State University Comprehensive Cancer Center

Publications and helpful links

Helpful Links

• The Jamesline

Study record dates

Study Major Dates

• Study Start (Actual): March 19, 2014
• Primary Completion (Actual): September 6, 2014
• Study Completion (Actual): September 6, 2014

Study Registration Dates

• First Submitted: February 26, 2015
• First Submitted That Met QC Criteria: February 26, 2015
• First Posted (Estimate): March 4, 2015

Study Record Updates

• Last Update Posted (Actual): June 24, 2020
• Last Update Submitted That Met QC Criteria: June 22, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Neoplasms; Depression; Depressive Disorder; Anxiety Disorders
• Other Study ID Numbers: OSU-12207; NCI-2014-00935 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No