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OpenTrials
Completed

NCT Number: NCT03130751

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

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.

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Key information

Conditions

Sarcoma Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue

Age range

13 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCLA Pediatric Pain Program Research Offices

Los Angeles, California, 90064, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Pocket Coach for AYA with Cancer

Behavioral

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.

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Collaborators

  • BodiMojo, Inc.

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Apr 26, 2017
Registry last updated
Oct 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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