- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05641961
Mobile App to Help Survivors of Childhood Cancer Navigate Long-Term Follow-Up Care
Utilizing a Mobile App to Help Survivors of Childhood Cancer Navigate Long-Term Follow-Up Care
Study Overview
Status
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVE:
I. To determine the difference in survivor/caregiver knowledge and understanding of diagnosis, treatment information, and follow-up needs using the survivorship app.
SECONDARY OBJECTIVE:
I. To validate the usability and effectiveness of the survivorship mobile application.
OUTLINE:
Participants are seen in the survivorship clinic and receive education about potential late effects and the survivorship application on study. Participants then use the survivorship app for 4 months on study.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Patricia Murphy, RN
- Phone Number: (415) 476-2700
- Email: Patricia.Murphy@ucsf.edu
Study Locations
-
-
California
-
San Francisco, California, United States, 94143
- Recruiting
- University of California, San Francisco
-
Principal Investigator:
- Robert Goldsby, MD
-
Contact:
- Patricia Murphy, RN
- Phone Number: 415-476-2700
- Email: Patricia.Murphy@ucsf.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Survivors of childhood cancer attending Survivorship Clinic at University of California, San Francisco (UCSF) OR caregivers of a childhood cancer survivor attending Survivorship Clinic at UCSF.
- Must have a mobile device (smartphone or smart-tablet) with service plan.
- Must have ability to read, write, and understand English language.
Exclusion Criteria:
- An individual who does not meet any of the criteria mentioned above will be excluded from participation in this study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Survivorship Mobile Application
Participants are seen in the survivorship clinic and receive education about potential late effects and the survivorship application on study.
Participants enrolled in this study will be asked to complete two self-administered questionnaires at 4 time points.
Questionnaires will be designed and made available electronically, to be completed on the participant's personal mobile device (e.g., mobile phone).
|
Mobile phone application
Other Names:
Questionnaires assessing cancer knowledge and system usability will be delivered to participants via Survivorship App
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in knowledge questionnaire score
Time Frame: Up to 4 months
|
The knowledge of the participant will be measured using a 12-item questionnaire that assesses the awareness of their treatment and health issues in four categories: (1) diagnosis, (2) treatment, (3) risks, and (4) recommended follow-up.
A scoring system has been devised which will give a score to each questionnaire out of 100 possible points.
The change in participants knowledge scores >=20 points from baseline will be reported.
|
Up to 4 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
System usability scale (SUS) score > 68
Time Frame: Up to 2 months
|
System Usability Scale (SUS) consists of a 10-item survey with five response options from Strongly agree to Strongly disagree.
The scoring of positive questions is done as follows: The user's score is reduced by one point.
For example, if the user's score is 4 for question 5, then the outcome score will be 3.
The scoring of negative questions is done as follows: The user's score is subtracted from 5. For example, if the user's score is 3 for question 4, then the new score will be 2.
After all the scores are determined, the sum of the scores is multiplied by 2.5 to make the range between 0 and 100.
Scores above 68 are considered above average.
The proportion of participants with an acceptable usability score > 68 will be reported.
|
Up to 2 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Robert Goldsby, MD, University of California, San Francisco
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 220813
- NCI-2022-09452 (Registry Identifier: NCI Clinical Trials Reporting Program (CTRP))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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