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

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

Study Overview

• Status: Completed
• Conditions: Cancer; Young Adults; Smartphone Application; Behavioral Intervention
• Intervention / Treatment: Other: iaya

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: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Dana-Farber Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 39 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: iaya Smart Phone Application; Pre-study evaluation; Access to the smartphone intervention over the course of 12 weeks; Post-study evaluation and interview	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.

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	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	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	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	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	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	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: Dana-Farber Cancer Institute
• Investigators: Principal Investigator: Hanneke Poort, PhD, Dana-Farber Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2019
• Primary Completion (Actual): June 29, 2020
• Study Completion (Actual): June 29, 2020

Study Registration Dates

• First Submitted: September 30, 2019
• First Submitted That Met QC Criteria: October 7, 2019
• First Posted (Actual): October 9, 2019

Study Record Updates

• Last Update Posted (Actual): December 8, 2020
• Last Update Submitted That Met QC Criteria: December 4, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Cancer; Behavioral Intervention; Young Adults; Smartphone Application
• Other Study ID Numbers: 19-333

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: Hanneke_Poort@dfci.harvard.edu. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
• IPD Sharing Time Frame: Data can be shared no earlier than 1 year following the date of publication
• IPD Sharing Access Criteria: DFCI - Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No