AnxietyBUCKiPADNCT02378012
iPad Use in Reducing Anxiety and Depression in Patients Undergoing Bone Marrow Transplant
A study testing Computer-Assisted Intervention and Questionnaire Administration in people with Anxiety and Depression, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety, Depression, Malignant Neoplasm
- What is being tested?
- Computer-Assisted Intervention and Questionnaire Administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Mar 2014to 6 Sep 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
Columbus, Ohio, 43210
About this study
Official title: 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.
Read the detailed description
PRIMARY OBJECTIVES:
- To evaluate the effect access to an iPad has on anxiety as measured by the Hospital Anxiety and Depression Scale.
SECONDARY OBJECTIVES:
- 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.
- Conditions
- Anxiety, Depression, Malignant Neoplasm
- Being tested
- Computer-Assisted Intervention, Questionnaire Administration
- Medical subject headings
- Anxiety Disorders, Depression, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer-Assisted InterventionOther
Receive access to Netflix, Spotify, and Skype applications
Computer-Assisted InterventionOther
Receive iPad and instruction manuals.
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Computer-Assisted Intervention; Other: 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. Receives: Other: Computer-Assisted Intervention; Other: Questionnaire Administration |
| GROUP C (no intervention) | No intervention | Participants do not receive an iPad for days -5 to 10. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to day 10
Secondary outcomes (2)
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.
Measured: 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.
Measured: Baseline to day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2015 (estimated)
- Study start19 Mar 2014
- Primary completion6 Sep 2014
- Study completion6 Sep 2014
Why it stopped: Competing study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Ohio State University Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samantha Jaglowski, Ohio State University Comprehensive Cancer Center
- Investigators
- Samantha Jaglowski, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02378012
- Sponsor's protocol ID
- OSU-12207
- Other IDs
- NCI-2014-00935
- Acronym
- BUCKiPAD
- Status last verified
- Jun 2020
- First submitted
- 26 Feb 2015
- Last updated
- 24 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project BUCKiPAD: The Evaluation of an iPAD Distribution Program on Anxiety and Depression in Bone and Marrow Transplant Patients
- ClinicalTrials.gov ID
- NCT02378012
- Acronym / sponsor ID
- BUCKiPAD / OSU-12207
- Conditions
- Anxiety, Depression, Malignant Neoplasm
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Competing study
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 19 Mar 2014 (actual)
- Primary completion
- 6 Sep 2014 (actual)
- Study completion
- 6 Sep 2014 (actual)
- First posted
- 4 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To evaluate the effect access to an iPad has on anxiety as measured by the Hospital Anxiety and Depression Scale.
SECONDARY OBJECTIVES:
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| GROUP A (participants provide own computer or tablet device) | Active comparator | Other: Computer-Assisted Intervention, Other: Questionnaire AdministrationA 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 BuckiPad) | Experimental | Other: Computer-Assisted Intervention, Other: Questionnaire AdministrationParticipants 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 (no intervention) | No intervention | –Participants do not receive an iPad for days -5 to 10. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- Patients who lack the visual or motor skills necessary to use a tablet device like the Apple iPad
- Patients who do not speak English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computer-Assisted InterventionReceive access to Netflix, Spotify, and Skype applications | Other | GROUP A (participants provide own computer or tablet device), GROUP B (Apple BuckiPad) |
| Computer-Assisted InterventionReceive iPad and instruction manuals. | Other | GROUP B (Apple BuckiPad) |
| Questionnaire AdministrationAncillary studies | Other | GROUP A (participants provide own computer or tablet device), GROUP B (Apple BuckiPad) |
Primary outcome
Change in Hospital Anxiety and Depression Scale (HADS)-Anxiety score
Time frame: Baseline to day 10
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.
2 secondary outcomes
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
Results and safety
The study was stopped early (reason given: Competing study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2020.
- The JameslineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samantha Jaglowski principal investigator
Ohio State University Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computer-Assisted Intervention and Questionnaire Administration in people with Anxiety and Depression, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Competing study). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Hospital Anxiety and Depression Scale (HADS)-Anxiety score (time frame: Baseline to day 10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2020.