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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05641961
Other study ID # 220813
Secondary ID NCI-2022-09452
Status Recruiting
Phase N/A
First received
Last updated
Start date November 29, 2022
Est. completion date April 30, 2024

Study information

Verified date April 2024
Source University of California, San Francisco
Contact Patricia Murphy, RN
Phone (415) 476-2700
Email Patricia.Murphy@ucsf.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This clinical trial studies the effectiveness of a newly developed survivorship mobile application (app) designed for survivors, or their caregivers, of childhood cancer to help them better navigate long-term follow-up care. The survivorship app provides survivors access to their treatment history and follow-up recommendations, improves knowledge of their diagnosis, treatment, risks, and recommended follow-up care by using a message notification. The ability to quickly connect and establish care planning may enhance adherence to recommended follow-up.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date April 30, 2024
Est. primary completion date April 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Survivorship mobile application
Mobile phone application
Other:
Questionnaires
Questionnaires assessing cancer knowledge and system usability will be delivered to participants via Survivorship App

Locations

Country Name City State
United States University of California, San Francisco San Francisco California

Sponsors (2)

Lead Sponsor Collaborator
University of California, San Francisco Swim Across America

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in knowledge questionnaire score 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 System usability scale (SUS) score > 68 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
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