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

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ClinicalTrials.gov Identifier: NCT03130751
Recruitment Status : Completed
First Posted : April 26, 2017
Last Update Posted : October 11, 2017
Sponsor:
Collaborator:
BodiMojo, Inc.
Information provided by (Responsible Party):
Lonnie Zeltzer, University of California, Los Angeles

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
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 : August 10, 2017
Actual Study Completion Date : August 10, 2017

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03130751


Locations
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United States, California
UCLA Pediatric Pain Program Research Offices
Los Angeles, California, United States, 90064
Sponsors and Collaborators
University of California, Los Angeles
BodiMojo, Inc.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Lonnie Zeltzer, Distinguished Professor, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT03130751     History of Changes
Other Study ID Numbers: 16-002064
First Posted: April 26, 2017    Key Record Dates
Last Update Posted: October 11, 2017
Last Verified: October 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No