SarcomaNCT03130751
Mobile Self Management and Support for Adolescents and Young Adults With Cancer
A study testing Pocket Coach for AYA with Cancer in people with Sarcoma, run by University of California, Los Angeles at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 25 years
- Conditions the study is for
- Sarcoma
- What is being tested?
- Pocket Coach for AYA with Cancer
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 23 May 2017to 10 Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA Pediatric Pain Program Research Offices
Los Angeles, California, 90064
About this study
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.
- Conditions
- Sarcoma
- Being tested
- Pocket Coach for AYA with Cancer
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pocket Coach for AYA with CancerBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Mobile application | Experimental | Not described Receives: Behavioral: Pocket Coach for AYA with Cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 30 days (from day 1 through day 30 of the 30-day intervention period)
Secondary outcomes (1)
Change in level of mindfulness
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.
Measured: Pre-intervention to post-intervention (a span of 30 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2017
- Study start23 May 2017
- Primary completion10 Aug 2017
- Study completion10 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SarcomaStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- BodiMojo, Inc.
- Responsible party
- Principal investigator, Lonnie Zeltzer, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03130751
- Sponsor's protocol ID
- 16-002064
- Status last verified
- Oct 2017
- First submitted
- 21 Apr 2017
- Last updated
- 11 Oct 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 33844938Donovan 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.
PubMed 30882352
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile Self Management and Support for Adolescents and Young Adults With Cancer
- ClinicalTrials.gov ID
- NCT03130751
- Acronym / sponsor ID
- 16-002064
- Conditions
- Sarcoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- BodiMojo, Inc.
- Study start
- 23 May 2017 (actual)
- Primary completion
- 10 Aug 2017 (actual)
- Study completion
- 10 Aug 2017 (actual)
- First posted
- 26 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mobile application | Experimental | Behavioral: Pocket Coach for AYA with Cancer |
Who may qualify
- Ages
- 13 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pocket Coach for AYA with CancerThe 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. | Behavioural | Mobile application |
Primary outcome
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).
1 secondary outcome
Change in level of mindfulness
Time frame: Pre-intervention to post-intervention (a span of 30 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2017.
- Derived from this study: PubMed 33844938Donovan 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.
- Derived from this study: PubMed 30882352Donovan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pocket Coach for AYA with Cancer in people with Sarcoma, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility (time frame: 30 days (from day 1 through day 30 of the 30-day intervention period)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03130751, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2017.