Overview

This trial is active, not recruiting.

Conditions anxiety, depression, malignant neoplasm
Treatments computer-assisted intervention, questionnaire administration
Sponsor Ohio State University Comprehensive Cancer Center
Start date March 2014
End date September 2014
Trial size 124 participants
Trial identifier NCT02378012, NCI-2014-00935, OSU-12207

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose supportive care
Arm
(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.
computer-assisted intervention
Receive access to Netflix, Spotify, and Skype applications
questionnaire administration
Ancillary studies
(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.
computer-assisted intervention
Receive access to Netflix, Spotify, and Skype applications
computer-assisted intervention
Receive iPad and instruction manuals.
questionnaire administration
Ancillary studies
(No Intervention)
Participants do not receive an iPad for days -5 to 10.

Primary Outcomes

Measure
Change in Hospital Anxiety and Depression Scale (HADS)-Anxiety score
time frame: Baseline to day 10

Secondary Outcomes

Measure
Change in HADS depression score
time frame: Baseline to day 10
Change in Profile of Mood States Short Form (POMS-SF) scores
time frame: Baseline to day 10

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Project BUCKiPAD: The Evaluation of an iPAD Distribution Program on Anxiety and Depression in Bone and Marrow Transplant Patients
Principal investigator Samantha Jaglowski
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Ohio State University Comprehensive Cancer Center.