Allo-SCT PatientsNCT02812082
Web-based Patient Education Program to Manage Side Effects of Allogeneic Stem Cell Transplant
A study testing web-based patient education and questionnaire in people with Allo-SCT Patients and Adult Allo-SCT Survivor, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to develop an interactive web-based patient education program to help educate patients about the increased risk of MS and its cardiac risk factors following allo-SCT and to inform and motivate patients how to make lifestyle changes. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Allo-SCT Patients, Adult Allo-SCT Survivor
- What is being tested?
- web-based patient education and questionnaire
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2016to Jun 2017
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The option to participate will be offered to male and female allo-SCT patients at MSK ≥ 21 years of age who are greater than 90 days post-transplant and followed in or referred to the adult allo-SCT survivorship clinic at MSK
- The option to participate will be offered to male and female allo-SCT patients at MSK ≥ 21 years of age who are greater than 90 days post-transplant and disease free, but have not yet been referred to the survivorship clinic
- Able to understand written and oral English
Who cannot join
- Patients less than 90 days post-transplant
- Patients without internet access
- Adult post-transplant patients who have relapsed prior to study recruitment
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
Official title: Developing and Assessing the Feasibility of Implementing a Video Web-based Patient Education Application
The purpose of this study is to develop an interactive web-based patient education program to help educate patients about the increased risk of MS and its cardiac risk factors following allo-SCT and to inform and motivate patients how to make lifestyle changes. This program will be used in addition to counseling at participants clinic visits. The investigators are not changing the recommendations for prevention and management of these conditions, but rather are trying to improve the way they provide this education to patients.
- Conditions
- Allo-SCT Patients, Adult Allo-SCT Survivor
- Being tested
- web-based patient education, questionnaire
- Keywords
- Web-based, patient education application, 16-769
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
web-based patient educationOther
questionnaireBehavioural
| Study group | Role | What they receive |
|---|---|---|
| video web-based patient education application | Experimental | This is a single-arm design. Development of the web-based application will occur over a 6 month period. Patient accrual will not occur until development of the program is complete. Controlled usability testing during the development/design process of the computer program will not be employed as we do not aim to assess the mechanics of patient use, but rather overall time spent interacting with the application in an uncontrolled environment. Following completion of the tool, patient accrual will occur over a six month time period in order to meet our target sample size of up to 50 participants. Participants will be directed to complete a pre-test questionnaire at the time of accrual and will have 3 months to use the program before being directed to complete the post-test questionnaire. Receives: Other: web-based patient education; Behavioral: questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients that use the application
A successful trial will be when ≥ 50% of enrolled patients use the application.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionJun 2017 (estimated)
Why it stopped: The PI is leaving MSK.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allo-SCT PatientsStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kara Mosesso, NP, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02812082
- Sponsor's protocol ID
- 16-769
- Status last verified
- Sep 2016
- First submitted
- 20 Jun 2016
- Last updated
- 14 Sep 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing and Assessing the Feasibility of Implementing a Video Web-based Patient Education Application
- ClinicalTrials.gov ID
- NCT02812082
- Acronym / sponsor ID
- 16-769
- Conditions
- Allo-SCT Patients, Adult Allo-SCT Survivor
- Keywords
- Web-based, patient education application, 16-769
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The PI is leaving MSK.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Jun 2017 (estimated)
- First posted
- 23 Jun 2016 (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.
The purpose of this study is to develop an interactive web-based patient education program to help educate patients about the increased risk of MS and its cardiac risk factors following allo-SCT and to inform and motivate patients how to make lifestyle changes. This program will be used in addition to counseling at participants clinic visits. The investigators are not changing the recommendations for prevention and management of these conditions, but rather are trying to improve the way they provide this education to patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| video web-based patient education application | Experimental | Other: web-based patient education, Behavioral: questionnaireThis is a single-arm design. Development of the web-based application will occur over a 6 month period. Patient accrual will not occur until development of the program is complete. Controlled usability testing during the development/design process of the computer program will not be employed as we do not aim to assess the mechanics of patient use, but rather overall time spent interacting with the application in an uncontrolled environment. Following completion of the tool, patient accrual will occur over a six month time period in order to meet our target sample size of up to 50 participants. Participants will be directed to complete a pre-test questionnaire at the time of accrual and will have 3 months to use the program before being directed to complete the post-test questionnaire. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The option to participate will be offered to male and female allo-SCT patients at MSK ≥ 21 years of age who are greater than 90 days post-transplant and followed in or referred to the adult allo-SCT survivorship clinic at MSK
- The option to participate will be offered to male and female allo-SCT patients at MSK ≥ 21 years of age who are greater than 90 days post-transplant and disease free, but have not yet been referred to the survivorship clinic
- Able to understand written and oral English
Key exclusion criteria (3 listed)
- Patients less than 90 days post-transplant
- Patients without internet access
- Adult post-transplant patients who have relapsed prior to study recruitment
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 |
|---|---|---|
| web-based patient education | Other | video web-based patient education application |
| questionnaire | Behavioural | video web-based patient education application |
Primary outcome
Percentage of patients that use the application
Time frame: 1 year
A successful trial will be when ≥ 50% of enrolled patients use the application.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2016.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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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.
Kara Mosesso, NP principal investigator
Memorial Sloan Kettering 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 web-based patient education and questionnaire in people with Allo-SCT Patients and Adult Allo-SCT Survivor, run by Memorial Sloan Kettering 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 3 inclusion and 3 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: withdrawn, as of the sponsor's last update on 14 Sep 2016. 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 withdrawn before enrolling participants, so there are no results.
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?
Percentage of patients that use the application (time frame: 1 year). 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 14 Sep 2016.