CancerNCT05842902
Resilience Mobile App for Teens and Young Adults With Cancer
A study testing mPRISM in people with Cancer, run by Seattle Children's Hospital at 1 site in United States.
Trial summary
The goal of this pilot trial is to examine whether a mobile app version of the Promoting Resilience in Stress Management (PRISM) intervention is acceptable, easy to use, and helps improve quality of life and mental health symptoms. Read more about this study
- Who is it for?
- Ages 12 to 25 years
- Conditions the study is for
- Cancer
- What is being tested?
- mPRISM
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Sep 2023to 1 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 12 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 12-25 years
- Diagnosis of new malignancy within 12 months of enrollment treated with chemotherapy and/or radiation therapy at Seattle Children's Hospital (SCH)
- Patient able to speak/read/write English or Spanish language
- Cognitively able to participate in mHealth psychosocial intervention and interactive interviews
Who cannot join
- Patient refusal to participate (any age), or parental refusal to participate for patients less than 18 years of age
- Patients with diagnosis of malignancy >12 months
- Patients with relapsed, recurrent, or refractory disease
- Patient without chemotherapy and/or radiation therapy as part of cancer treatment (e.g., surgical resection only patients are not-eligible)
- Cognitively or physically unable to participate in mHealth psychosocial intervention and surveys
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Seattle Children's Hospital
Seattle, Washington, 98105
Nancy Lau, PhD, 206-884-8238, nancy.lau@seattlechildrens.org
About this study
Official title: Pilot Trial Testing Mobile Health Psychosocial Intervention for Adolescents and Young Adults With Cancer
The goal of this pilot trial is to examine whether a mobile app version of the Promoting Resilience in Stress Management (PRISM) intervention is acceptable, easy to use, and helps improve quality of life and mental health symptoms.
Read the detailed description
Adolescents and Young Adults (AYAs) with cancer are at risk of distress, anxiety, depression, and poor quality of life. The use of mobile applications for psychosocial symptom self-management is appealing to this demographic population but this has not yet been developed and tested.
PRISM is a novel, brief, evidence-based 1:1 intervention that teaches stress management, goal-setting, meaning making, cognitive-behavioral, and mindfulness strategies. Here, we propose to test a mobile health (mHealth) version of PRISM, mPRISM. In a pilot randomized controlled trial, we will evaluate the feasibility, acceptability, and exploratory efficacy of mPRISM using a waitlist control design.
- Conditions
- Cancer
- Being tested
- mPRISM
- Keywords
- Mobile health, Quality of life, Adolescent, Young Adult, Psychosocial factors
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mPRISMBehavioural
PRISM is a brief, 1:1, skills-based resilience intervention delivered in-person by trained layperson coaches. PRISM's development was based on iterative research within the AYA oncology population, stress and coping theory, resilience theory, and successful cognitive-behavioral and mindfulness interventions. mPRISM is a digital version of the PRISM program with no in-person delivery. mPRISM includes coping skills modules: managing stress, goal-setting, cognitive reframing, and meaning-making.
| Study group | Role | What they receive |
|---|---|---|
| mPRISM | Experimental | The Experimental (mPRISM) arm will receive mPRISM upon completion of their baseline study surveys. Receives: Behavioral: mPRISM |
| Waitlist control | Other | Usual Care (UC) available to both study arms consists of standard non-directed supportive care provided for all patients including an assigned social worker throughout cancer treatment. In a waitlist design, the UC arm will receive mPRISM upon completion of 3-month follow-up surveys. Receives: Behavioral: mPRISM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of intervention
The Acceptability of Intervention Measure (AIM) is a well-validated 4-item scale that measures the perception among implementation stakeholders that a given treatment, service, practice, or innovation is agreeable, palatable, or satisfactory. Scale ranges from 4 to 20; higher scores are better.
Measured: immediately post-intervention
Appropriateness of intervention
The Intervention Appropriateness Measure (IAM) is a well-validated 4-item scale that measures the perceived fit, relevance, or compatibility of the innovation or evidence-based practice for a given practice setting, provider, or consumer, and/or perceived fit of the innovation to address a particular issue or problem. Scale ranges from 4 to 20; higher scores are better.
Measured: immediately post-intervention
Feasibility of intervention
The Feasibility of Intervention Measure (FIM) is a well-validated 4-item scale that measures the extent to which a new treatment, or an innovation, can be successfully used or carried out within a given agency or setting. Scale ranges from 4 to 20; higher scores are better.
Measured: immediately post-intervention
Secondary outcomes (5)
Usability of intervention
The System Usability Scale (SUS) is a well-validated and widely used 10-item scale to evaluate the perceived usability of digital interventions. Items are rated on a 5-point Likert scale for a total score ranging from 0-100, and scores ≥70 considered adequate usability.
Measured: immediately post-intervention
Change in health-related quality of life
The PedsQL 4.0 Generic and 3.0 Cancer Module include 50 items evaluating health-related quality of life (HRQOL) of AYAs with cancer. Queries assess physical, emotional, social, and school well-being, plus cancer-related pain and hurt, nausea, procedural anxiety, treatment anxiety, worry, cognitive problems, perceived physical appearance, and communication. Scores are linearly transformed to a 0-100 scale, with higher scores indicating better HRQOL.
Measured: immediately post-intervention, 3 months post-intervention
Change in resilience
The CD-RISC is a well-validated and widely used 10-item instrument to measure inherent resiliency. Questions revolve around personal problem-solving and approaches to adversity. Scores range from 0-40, with higher scores indicating higher resilience.
Measured: immediately post-intervention, 3 months post-intervention
Change in distress
This 6-item scale measures "level of psychological distress experienced in the past month." The instrument strongly discriminates between community cases and non-cases of Diagnostic and Statistical Manual of Mental Disorder (DSM)-V psychiatric disorders such as serious emotional distress or serious mental illness. Scores range from 0-24, with higher scores indicating higher distress.
Measured: immediately post-intervention, 3 months post-intervention
Change in anxiety and depression
7 items assess symptoms of anxiety and depression, respectively, in patients with serious illness. It has been validated in AYAs with chronic illness and cancer survivors, with excellent reliability (α=0.83-0.82). Items are scored 0-3 (subscale range 0-21), with scores ≥8 categorized as borderline abnormal, and ≥11 categorized as abnormal.
Measured: immediately post-intervention, 3 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start12 Sep 2023
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Seattle Children's HospitalThe 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized waitlist design: AYAs will be randomized 1:1 to psychosocial Usual Care (UC) or UC plus mPRISM. mPRISM will be provided to UC arm at 3-month follow-up.
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seattle Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Washington
- Responsible party
- Principal investigator, Nancy, Seattle Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05842902
- Sponsor's protocol ID
- STUDY00004006
- Status last verified
- Jul 2026
- First submitted
- 21 Apr 2023
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lau N, Palermo TM, Zhou C, Badillo I, Hong S, Aalfs H, Yi-Frazier JP, McCauley E, Chow EJ, Weiner BJ, Ben-Zeev D, Rosenberg AR. Mobile App Promoting Resilience in Stress Management for Adolescents and Young Adults With Cancer: Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2024 Jul 30;13:e57950. doi: 10.2196/57950.
PubMed 39079108
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Trial Testing Mobile Health Psychosocial Intervention for Adolescents and Young Adults With Cancer
- ClinicalTrials.gov ID
- NCT05842902
- Acronym / sponsor ID
- STUDY00004006
- Conditions
- Cancer
- Keywords
- Mobile health, Quality of life, Adolescent, Young Adult, Psychosocial factors
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Seattle Children's HospitalUniversity, hospital or other
- Collaborators
- University of Washington
- Study start
- 12 Sep 2023 (actual)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 6 May 2023 (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.
The goal of this pilot trial is to examine whether a mobile app version of the Promoting Resilience in Stress Management (PRISM) intervention is acceptable, easy to use, and helps improve quality of life and mental health symptoms.
Detailed description
Adolescents and Young Adults (AYAs) with cancer are at risk of distress, anxiety, depression, and poor quality of life. The use of mobile applications for psychosocial symptom self-management is appealing to this demographic population but this has not yet been developed and tested.
PRISM is a novel, brief, evidence-based 1:1 intervention that teaches stress management, goal-setting, meaning making, cognitive-behavioral, and mindfulness strategies. Here, we propose to test a mobile health (mHealth) version of PRISM, mPRISM. In a pilot randomized controlled trial, we will evaluate the feasibility, acceptability, and exploratory efficacy of mPRISM using a waitlist control design.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized waitlist design: AYAs will be randomized 1:1 to psychosocial Usual Care (UC) or UC plus mPRISM. mPRISM will be provided to UC arm at 3-month follow-up.
| Arm | Type | Receives |
|---|---|---|
| mPRISM | Experimental | Behavioral: mPRISMThe Experimental (mPRISM) arm will receive mPRISM upon completion of their baseline study surveys. |
| Waitlist control | Other | Behavioral: mPRISMUsual Care (UC) available to both study arms consists of standard non-directed supportive care provided for all patients including an assigned social worker throughout cancer treatment. In a waitlist design, the UC arm will receive mPRISM upon completion of 3-month follow-up surveys. |
Who may qualify
- Ages
- 12 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Age 12-25 years
- Diagnosis of new malignancy within 12 months of enrollment treated with chemotherapy and/or radiation therapy at Seattle Children's Hospital (SCH)
- Patient able to speak/read/write English or Spanish language
- Cognitively able to participate in mHealth psychosocial intervention and interactive interviews
Key exclusion criteria (5 listed)
- Patient refusal to participate (any age), or parental refusal to participate for patients less than 18 years of age
- Patients with diagnosis of malignancy >12 months
- Patients with relapsed, recurrent, or refractory disease
- Patient without chemotherapy and/or radiation therapy as part of cancer treatment (e.g., surgical resection only patients are not-eligible)
- Cognitively or physically unable to participate in mHealth psychosocial intervention and surveys
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 |
|---|---|---|
| mPRISMPRISM is a brief, 1:1, skills-based resilience intervention delivered in-person by trained layperson coaches. PRISM's development was based on iterative research within the AYA oncology population, stress and coping theory, resilience theory, and successful cognitive-behavioral and mindfulness interventions. mPRISM is a digital version of the PRISM program with no in-person delivery. mPRISM includes coping skills modules: managing stress, goal-setting, cognitive reframing, and meaning-making. | Behavioural | Waitlist control, mPRISM |
Primary outcome
Acceptability of intervention
Time frame: immediately post-intervention
The Acceptability of Intervention Measure (AIM) is a well-validated 4-item scale that measures the perception among implementation stakeholders that a given treatment, service, practice, or innovation is agreeable, palatable, or satisfactory. Scale ranges from 4 to 20; higher scores are better.
Appropriateness of intervention
Time frame: immediately post-intervention
The Intervention Appropriateness Measure (IAM) is a well-validated 4-item scale that measures the perceived fit, relevance, or compatibility of the innovation or evidence-based practice for a given practice setting, provider, or consumer, and/or perceived fit of the innovation to address a particular issue or problem. Scale ranges from 4 to 20; higher scores are better.
Feasibility of intervention
Time frame: immediately post-intervention
The Feasibility of Intervention Measure (FIM) is a well-validated 4-item scale that measures the extent to which a new treatment, or an innovation, can be successfully used or carried out within a given agency or setting. Scale ranges from 4 to 20; higher scores are better.
5 secondary outcomes
Usability of intervention
Time frame: immediately post-intervention
Change in health-related quality of life
Time frame: immediately post-intervention, 3 months post-intervention
Change in resilience
Time frame: immediately post-intervention, 3 months post-intervention
Change in distress
Time frame: immediately post-intervention, 3 months post-intervention
Change in anxiety and depression
Time frame: immediately post-intervention, 3 months post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Derived from this study: PubMed 39079108Lau N, Palermo TM, Zhou C, Badillo I, Hong S, Aalfs H, Yi-Frazier JP, McCauley E, Chow EJ, Weiner BJ, Ben-Zeev D, Rosenberg AR. Mobile App Promoting Resilience in Stress Management for Adolescents and Young Adults With Cancer: Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2024 Jul 30;13:e57950. doi: 10.2196/57950.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mPRISM in people with Cancer, run by Seattle Children's Hospital 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 4 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 3 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nancy Lau, PhD (206-884-0569, nancy.lau@seattlechildrens.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of intervention (time frame: immediately post-intervention). The study lists 3 primary outcomes in all. 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 NCT05842902, which also lists 1 linked publication.
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 3 Aug 2026.