Mobile Self Management and Support for Adolescents and Young Adults With Cancer

October 9, 2017 updated by: Lonnie Zeltzer, University of California, Los Angeles
This study is the user testing phase of a mobile application intervention which will be designed to promote positive coping skills, illness resilience, and social support, and to serve as a complement to patient-physician interactions in adolescents and young adults (AYA) with sarcoma. User testing will be conducted with a prototype of the app. Participants will be AYA ages 13-25 with sarcoma (N=16). Study participation involves the AYAs downloading and using the app for 30 days. During the 30 days, participants will interact with the app by inputting their current mood, receiving supportive feedback from the app, reading messages, and doing brief activities (such as relaxation activities, etc.). Participants will also participate in an online focus group focused around the user experience. Before and after the 30 days of user testing, participants will complete a few brief questionnaires about their behavior, how their symptoms affect their life, and how they receive support from others. These questions will take around 20 minutes to complete at each administration.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90064
        • UCLA Pediatric Pain Program Research Offices

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 25 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Parent or self-reported (for participants 18+ years old) physician diagnosis of sarcoma
  2. Daily use of a smartphone (iOS, Android, or Windows) or tablet
  3. Current Facebook account that participant can use to participate in the focus group (or, be willing to create a Facebook account for this purpose).
  4. Able and willing to give informed assent and comply with study requirements
  5. For patients aged 13-17 years, have one caregiver willing and able to participate in the study
  6. Able to read and speak English

Exclusion Criteria:

  1. Patients that are not able to participate in the study due to their medical condition and/or treatment regimen, as determined by the patients' treating oncologist in conjunction with patients' family members
  2. Inability to provide informed assent/permission/consent
  3. Inability to read, speak, and understand English

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mobile application
Behavioral: Pocket Coach for AYA with Cancer
The Pocket Coach for AYA with Cancer is a psychosocial intervention to be delivered through a mobile platform. Intervention content is based on Mindfulness Based Stress Reduction (MBSR) and the Resilience in Illness Model [Dr. Joan E. Haase et al] and includes modules on relaxation, mindfulness, cognitions, and self-compassion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility
Time Frame: 30 days (from day 1 through day 30 of the 30-day intervention period)
Determined by the number of days participants use the program. Program usage will be assessed on the back end of the technology platform, which tracks how often each participant opens the app and uses any of the features. Intervention will be deemed feasible if participants use the program on at least two thirds of the 30 days in the study period (i.e., 20 out of the 30 days).
30 days (from day 1 through day 30 of the 30-day intervention period)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in level of mindfulness
Time Frame: Pre-intervention to post-intervention (a span of 30 days)
Assessed by the change in the total score on the Child and Adolescent Mindfulness Measure (CAMM) from pre-intervention to post-intervention. Calculated by subtracting the pre-intervention score from the post-intervention score. The CAMM is a 10-item measure whose total score can range from 0-40. Higher scores correspond to higher levels of mindfulness.
Pre-intervention to post-intervention (a span of 30 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Los Angeles

Collaborators

BodiMojo, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 23, 2017

Primary Completion (Actual)

August 10, 2017

Study Completion (Actual)

August 10, 2017

Study Registration Dates

First Submitted

April 21, 2017

First Submitted That Met QC Criteria

April 21, 2017

First Posted (Actual)

April 26, 2017

Study Record Updates

Last Update Posted (Actual)

October 11, 2017

Last Update Submitted That Met QC Criteria

October 9, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16-002064

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Sarcoma

Clinical Trials on Pocket Coach for AYA with Cancer

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Chile

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe