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Clinical Trials/NCT04119869
NCT04119869CompletedNot Applicable

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

Dana-Farber Cancer Institute2 sites in 1 country25 target enrollmentStarted: November 11, 2019Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
25
Locations
2
Primary Endpoint
Mean score on app usability questionnaire

Study Overview

Brief Summary

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

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 Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
18 Years to 39 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

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.

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.

Secondary Outcomes

  • Change in self-efficacy scores on the PROMIS Self-Efficacy for Managing Emotions Scale(12 weeks)
  • Change in coping scores on the Cancer Behavior Inventory Brief Form(12 weeks)
  • Change in emotional support on the PROMIS Emotional Support Scale(12 weeks)
  • Change in quality of life on the Functional Assessment of Cancer Therapy-General Scale(12 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Hanneke Poort PhD

Principal Investigator

Dana-Farber Cancer Institute

Study Sites (2)

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