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

• Sponsor: University of California, Los Angeles (Other)
• Overall Status: Completed
• CT.gov ID: NCT03130751
• Collaborator: BodiMojo, Inc. (Other)
• Enrollment: 20
• Location: 1
• Arm: 1
• Actual Duration (Months): 2.6
• Patients Per Site Per Month: 7.7

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Sarcoma	Behavioral: Pocket Coach for AYA with Cancer	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Mobile Self Management and Support for Adolescents and Young Adults With Cancer
• Actual Study Start Date: May 23, 2017
• Actual Primary Completion Date: Aug 10, 2017
• Actual Study Completion Date: Aug 10, 2017

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Feasibility [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).

Secondary Outcome Measures

1. Change in level of mindfulness [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 13 Years to 25 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UCLA Pediatric Pain Program Research Offices	Los Angeles	California	United States	90064

Sponsors and Collaborators

• University of California, Los Angeles
• BodiMojo, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Lonnie Zeltzer, Distinguished Professor, University of California, Los Angeles
• ClinicalTrials.gov Identifier: NCT03130751
• Other Study ID Numbers: 16-002064
• First Posted: Apr 26, 2017
• Last Update Posted: Oct 11, 2017
• Last Verified: Oct 1, 2017

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Sarcoma

Study Results

No Results Posted as of Oct 11, 2017