- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04119869
Smart Phone App Intervention In Young Adults With Cancer
Feasibility and Acceptability of a Smart Phone Application Intervention to Enhance Coping for Young Adults With Cancer
Study Overview
Status
Intervention / Treatment
Detailed Description
The iaya app was developed by clinicians from the Young Adult Program at the Dana-Farber Cancer Institute. The iaya app is a smartphone application intervention that -through a variety of approaches, such as exercises aimed at identifying and changing thoughts and behaviors, imagery, and relaxation- seeks to enhance coping with the emotional impact of cancer.
The investigators are conducting this study to see if the iaya app, specifically developed for young adults with cancer, is practical, to determine patient satisfaction with the iaya app, and to test study procedures.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02215
- Dana-Farber Cancer Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients aged 18-39 years
- Able to speak/read English
- Have a smart phone
- Receiving cancer treatment
- Active cancer care from an oncologist at Dana-Farber Cancer Institute
Exclusion Criteria:
- Neurological/cognitive condition interfering with the ability to understand and adhere to study procedures
- Adults unable to consent
- Individuals who are not yet adults (infants, children, teenagers)
- Pregnant women
- Prisoners
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: iaya Smart Phone Application
|
The iaya app is a smartphone application intervention that -through a variety of approaches, such as exercises aimed at identifying and changing thoughts and behaviors, imagery, and relaxation- seeks to enhance coping with the emotional impact of cancer.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants who log in at least 10 times and open at least 3 coping skills exercises
Time Frame: 12 weeks
|
Feasibility of iaya will be determined by calculating the percent of participants assigned to the iaya app who log in at least 10 times.
Percent of participants assigned to the iaya app will open at least 3 coping skills exercises will also be considered as a component of feasibility.
|
12 weeks
|
Mean score on app usability questionnaire
Time Frame: 12 weeks
|
Acceptability will be assessed with the 6-item app usability questionnaire rated on a Likert scale (0=strong disagree to 5=strongly agree).
Items will prompt participants to rate the extend to which they would use this app frequently, found the app to be easy to use, well organized, learn how to use the app quickly, felt confident using the app, and if they found the app interactive.
Scores can range from 0-30.
Higher scores indicate higher perception of usability.
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in coping scores on the Cancer Behavior Inventory Brief Form
Time Frame: 12 weeks
|
We will pilot the 12-item Cancer Behavior Inventory Brief Form (CBI-B) for future efficacy studies. The CBI-B measures self-efficacy for coping with cancer. Items are scored between 1 (not at all confident) to 9 (totally confident). Higher scores indicate a higher level of self-efficacy for coping with cancer. among young adults with cancer who had access to the iaya app for future efficacy studies. |
12 weeks
|
Change in self-efficacy scores on the PROMIS Self-Efficacy for Managing Emotions Scale
Time Frame: 12 weeks
|
We will pilot the 8-item PROMIS Self-Efficacy for Managing Emotions (PROMIS SEMEM) for future efficacy studies.
The PROMIS SEMEM will be used to measure confidence to manage or control symptoms of anxiety, depression, helplessness, discouragement, frustration, disappointment, and anger.
Items are scored on a scale from 1 (not at all confident) to 5 (very confident).
Higher scores indicate a higher level of self-efficacy for managing emotions.
|
12 weeks
|
Change in emotional support on the PROMIS Emotional Support Scale
Time Frame: 12 weeks
|
We will pilot the 12-item PROMIS Emotional Support (PROMIS ES) for future efficacy studies.
The PROMIS ES measures perceived feelings of being cared for and valued as a person.
Items are scores on a scale from 1 (never) to 5 (always).
Higher scores indicate higher levels of perceived emotional support.
|
12 weeks
|
Change in quality of life on the Functional Assessment of Cancer Therapy-General Scale
Time Frame: 12 weeks
|
We will pilot the 27-item Functional Assessment of Cancer Therapy-General (FACT-G) for future efficacy studies.
The FACT-G consists of four sub scales: physical, emotional, social/family, and functional well-being.
Items are scores between 0 (not at all) and 4 (very much).
Higher scores indicate a higher level of quality of life.
|
12 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Hanneke Poort, PhD, Dana-Farber Cancer Institute
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Other Study ID Numbers
- 19-333
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
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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