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

September 13, 2016 updated by: Memorial Sloan Kettering Cancer Center

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Behavioral: questionnaire
Other: web-based patient education

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of patients that use the application
Time Frame: 1 year
A successful trial will be when ≥ 50% of enrolled patients use the application.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Investigators

  • Principal Investigator: Kara Mosesso, NP, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (Anticipated)

June 1, 2017

Study Registration Dates

First Submitted

June 20, 2016

First Submitted That Met QC Criteria

June 21, 2016

First Posted (Estimate)

June 23, 2016

Study Record Updates

Last Update Posted (Estimate)

September 14, 2016

Last Update Submitted That Met QC Criteria

September 13, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 16-769

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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