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

Primary Purpose

Anxiety, Depression, Malignant Neoplasm

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Computer-Assisted Intervention
Computer-Assisted Intervention
Questionnaire Administration
Sponsored by
Ohio State University Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Anxiety

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

No Intervention

Arm Label

GROUP A (participants provide own computer or tablet device)

GROUP B (Apple BuckiPad)

GROUP C (no intervention)

Arm Description

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.

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
February 26, 2015
Last Updated
June 22, 2020
Sponsor
Ohio State University Comprehensive Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT02378012
Brief Title
iPad Use in Reducing Anxiety and Depression in Patients Undergoing Bone Marrow Transplant
Acronym
BUCKiPAD
Official Title
Project BUCKiPAD: The Evaluation of an iPAD Distribution Program on Anxiety and Depression in Bone and Marrow Transplant Patients
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Terminated
Why Stopped
Competing study
Study Start Date
March 19, 2014 (Actual)
Primary Completion Date
September 6, 2014 (Actual)
Study Completion Date
September 6, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University Comprehensive Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Depression, Malignant Neoplasm

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GROUP A (participants provide own computer or tablet device)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
GROUP B (Apple BuckiPad)
Arm Type
Experimental
Arm Description
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.
Arm Title
GROUP C (no intervention)
Arm Type
No Intervention
Arm Description
Participants do not receive an iPad for days -5 to 10.
Intervention Type
Other
Intervention Name(s)
Computer-Assisted Intervention
Intervention Description
Receive access to Netflix, Spotify, and Skype applications
Intervention Type
Other
Intervention Name(s)
Computer-Assisted Intervention
Intervention Description
Receive iPad and instruction manuals.
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Change in Hospital Anxiety and Depression Scale (HADS)-Anxiety score
Description
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.
Time Frame
Baseline to day 10
Secondary Outcome Measure Information:
Title
Change in HADS depression score
Description
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.
Time Frame
Baseline to day 10
Title
Change in Profile of Mood States Short Form (POMS-SF) scores
Description
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.
Time Frame
Baseline to day 10

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samantha Jaglowski
Organizational Affiliation
Ohio State University Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://cancer.osu.edu
Description
The Jamesline

Learn more about this trial

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

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