NCT03130751

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

April 21, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 26, 2017

Completed
27 days until next milestone

Study Start

First participant enrolled

May 23, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 10, 2017

Completed
Last Updated

October 11, 2017

Status Verified

October 1, 2017

Enrollment Period

3 months

First QC Date

April 21, 2017

Last Update Submit

October 9, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Feasibility

    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 Outcomes (1)

  • Change in level of mindfulness

    Pre-intervention to post-intervention (a span of 30 days)

Study Arms (1)

Mobile application

EXPERIMENTAL
Behavioral: Pocket Coach for AYA with Cancer

Interventions

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.

Mobile application

Eligibility Criteria

Age13 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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
  • Inability to provide informed assent/permission/consent
  • Inability to read, speak, and understand English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCLA Pediatric Pain Program Research Offices

Los Angeles, California, 90064, United States

Location

Related Publications (2)

  • Donovan E, Martin SR, Seidman LC, Zeltzer LK, Cousineau TM, Payne LA, Knoll M, Weiman M, Federman NC. The Role of Social Media in Providing Support from Friends for Adolescent and Young Adult (AYA) Patients and Survivors of Sarcoma: Perspectives of AYA, Parents, and Providers. J Adolesc Young Adult Oncol. 2021 Dec;10(6):720-725. doi: 10.1089/jayao.2020.0200. Epub 2021 Apr 12.

  • Donovan E, Martin SR, Seidman LC, Zeltzer LK, Cousineau TM, Payne LA, Trant M, Weiman M, Knoll M, Federman NC. A Mobile-Based Mindfulness and Social Support Program for Adolescents and Young Adults With Sarcoma: Development and Pilot Testing. JMIR Mhealth Uhealth. 2019 Mar 18;7(3):e10921. doi: 10.2196/10921.

MeSH Terms

Conditions

Sarcoma

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

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
Distinguished Professor

Study Record Dates

First Submitted

April 21, 2017

First Posted

April 26, 2017

Study Start

May 23, 2017

Primary Completion

August 10, 2017

Study Completion

August 10, 2017

Last Updated

October 11, 2017

Record last verified: 2017-10

Locations