An interventional study of Computer-Assisted Intervention and Computer-Assisted Intervention in Anxiety, Depression and Malignant Neoplasm, sponsored by Ohio State University Comprehensive Cancer Center. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-06-24.
Sponsored by Ohio State University Comprehensive Cancer Center · Not applicable, Interventional, and Supportive care
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.
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.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's enrollment of 6 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Ohio State University Comprehensive Cancer Center is the lead sponsor of 369 studies on the registry; 81 are open to participants now.
Of its 38 completed or terminated interventional studies of FDA-regulated products, 19 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients who lack the visual or motor skills necessary to use a tablet device like the Apple iPad
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 Intervention · Other: Questionnaire Administration
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 Intervention · Other: Questionnaire Administration
Participants do not receive an iPad for days -5 to 10.
Receive access to Netflix, Spotify, and Skype applications
Receive iPad and instruction manuals.
Ancillary studies
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.
Time frame: Baseline to day 10
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.
Time frame: 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.
Time frame: Baseline to day 10
Plan to share: No
This study is terminated, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.
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Ohio State University Comprehensive Cancer Center