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Web-based Patient Education Program to Manage Side Effects of Allogeneic Stem Cell Transplant

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02812082
Recruitment Status : Withdrawn (The PI is leaving MSK.)
First Posted : June 23, 2016
Last Update Posted : September 14, 2016
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Tracking Information
First Submitted Date  ICMJE June 20, 2016
First Posted Date  ICMJE June 23, 2016
Last Update Posted Date September 14, 2016
Study Start Date  ICMJE June 2016
Estimated Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 21, 2016)
Percentage of patients that use the application [ Time Frame: 1 year ]
A successful trial will be when ≥ 50% of enrolled patients use the application.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Web-based Patient Education Program to Manage Side Effects of Allogeneic Stem Cell Transplant
Official Title  ICMJE Developing and Assessing the Feasibility of Implementing a Video Web-based Patient Education Application
Brief 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. 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Allo-SCT Patients
  • Adult Allo-SCT Survivor
Intervention  ICMJE
  • Other: web-based patient education
  • Behavioral: questionnaire
Study Arms  ICMJE Experimental: video web-based patient education application
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.
Interventions:
  • Other: web-based patient education
  • Behavioral: questionnaire
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: September 13, 2016)
0
Original Estimated Enrollment  ICMJE
 (submitted: June 21, 2016)
50
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Patients less than 90 days post-transplant
  • Patients without internet access
  • Adult post-transplant patients who have relapsed prior to study recruitment
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02812082
Other Study ID Numbers  ICMJE 16-769
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Memorial Sloan Kettering Cancer Center
Study Sponsor  ICMJE Memorial Sloan Kettering Cancer Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kara Mosesso, NP Memorial Sloan Kettering Cancer Center
PRS Account Memorial Sloan Kettering Cancer Center
Verification Date September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP