Smart Phone App Intervention In Young Adults With Cancer

Cancer Clinical Trial

Official title:

Feasibility and Acceptability of a Smart Phone Application Intervention to Enhance Coping for Young Adults With Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04119869
• Other study ID #: 19-333
• Status: Completed
• Phase: N/A
• Start date: November 11, 2019
• Est. completion date: June 29, 2020

Study information

• Verified date: December 2020
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This research study aims to explore the feasibility and acceptability of a smartphone application intervention, called iaya, among young adults with cancer.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: June 29, 2020
• Est. primary completion date: June 29, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 39 Years

Eligibility

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

Related Conditions & MeSH terms

• Behavioral Intervention
• Cancer
• Smartphone Application
• Young Adults

Intervention

Other:
• iaya
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.

Locations

Country	Name	City	State
United States	Dana-Farber Cancer Institute	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants who log in at least 10 times and open at least 3 coping skills exercises	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
Primary	Mean score on app usability questionnaire	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	Change in coping scores on the Cancer Behavior Inventory Brief Form	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
Secondary	Change in self-efficacy scores on the PROMIS Self-Efficacy for Managing Emotions Scale	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
Secondary	Change in emotional support on the PROMIS Emotional Support Scale	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
Secondary	Change in quality of life on the Functional Assessment of Cancer Therapy-General Scale	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