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
1 other identifier
interventional
25
1 country
1
Brief Summary
This research study aims to explore the feasibility and acceptability of a smartphone application intervention, called iaya, among young adults with cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable cancer
Started Nov 2019
Shorter than P25 for not_applicable cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 30, 2019
CompletedFirst Posted
Study publicly available on registry
October 9, 2019
CompletedStudy Start
First participant enrolled
November 11, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 29, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 29, 2020
CompletedDecember 8, 2020
December 1, 2020
8 months
September 30, 2019
December 4, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (4)
Change in coping scores on the Cancer Behavior Inventory Brief Form
12 weeks
Change in self-efficacy scores on the PROMIS Self-Efficacy for Managing Emotions Scale
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
Study Arms (1)
iaya Smart Phone Application
EXPERIMENTAL* Pre-study evaluation * Access to the smartphone intervention over the course of 12 weeks * Post-study evaluation and interview
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
MeSH Terms
Conditions
Study Officials
- PRINCIPAL INVESTIGATOR
Hanneke Poort, PhD
Dana-Farber Cancer Institute
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 30, 2019
First Posted
October 9, 2019
Study Start
November 11, 2019
Primary Completion
June 29, 2020
Study Completion
June 29, 2020
Last Updated
December 8, 2020
Record last verified: 2020-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Data can be shared no earlier than 1 year following the date of publication
- Access Criteria
- DFCI - Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
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.