Skip to main content
OpenTrials
Completed

NCT Number: NCT04119869

Smart Phone App Intervention In Young Adults With Cancer

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cancer Behavioral Intervention Neoplasms Smartphone Application Young Adults

Age range

18 year–39 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

iaya

Other

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 9, 2019
Registry last updated
Dec 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.