StressNCT06038318
Promoting Resilience in Early Survivorship Among Adolescents and Young Adults With Cancer
A study testing PRISM Program Video Coach, PRISM Program Text Coach and mPRISM Program App in people with Stress and Anxiety, run by Dana-Farber Cancer Institute at 2 sites in United States.
Trial summary
The goal of this study is to find the best way to help participants and families manage the stress of facing a serious illness and be better able to "bounce back" or be resilient after a difficult situation. Read more about this study
- Who is it for?
- Ages 12 to 25 yearsHealthy volunteers can take part
- What is being tested?
- PRISM Program Video Coach, PRISM Program Text Coach and mPRISM Program App
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 325 participants
- Where
- 2 sitesUnited States
- Study dates
- 16 Oct 2023to 1 May 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
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- All genders ≥ 12 and ≤ 25 years of age at baseline
- Participant is able to speak English or Spanish language (for PRISM sessions)
- Participant is able to read English or Spanish language (for completion of surveys)
- Participant is cognitively able to participate in PRISM sessions and complete written questionnaires and surveys, as judged by the site investigator
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Not yet recruiting
Boston Children's Hospital
Boston, Massachusetts, 02215
Abby Rosenberg, MD, 206-987-6892, abbyr_rosenberg@dfci.harvard.edu
Abby Rosenberg, MD
- Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Abby Rosenberg, MD, 206-987-6892, abbyr_rosenberg@dfci.harvard.edu
Abby Rosenberg, MD
About this study
The goal of this study is to find the best way to help participants and families manage the stress of facing a serious illness and be better able to "bounce back" or be resilient after a difficult situation. Participants will take part in the "Promoting Resilience in Stress Management" PRISM program, which is designed to provide skills to change or improve the impact of stress in everyday life.
The name of the intervention used in this research study is:
-PRISM (a mobile app program comprised of 6 sessions of skills-based, manualized resilience education)
Read the detailed description
In this sequential, multiple assignment, randomized trial participants will be randomly selected to participate in PRISM program sessions with a trained research coach either by text or by video sessions, or participants will use the PRISM mobile app program in a self-guided way. Randomization means the group participants are placed in will be decided by chance. All groups will continue to receive all the same care from primary medical, social work, and other care teams.
In this two-stage study, participants will be randomly assigned to either the "app-only" (20% chance), "text" (40% chance) or "video" (40% chance) groups for the first stage. In the second stage, participants may be re-randomized again to the "app-only," or "text," groups, or will be referred to a specialty psychosocial support, social worker or counselor, based on responses to questionnaires. Participants randomized to the "app-only" group in the first stage will not be re-randomized.
The research study procedures include screening for eligibility and completion of questionnaires.
Participation in this research study is expected to last for up to 6 months.
It is expected about 325 people will take part in this research study.
The National Institute for Health (NIH) is funding this research study.
- Being tested
- PRISM Program Video Coach, PRISM Program Text Coach, mPRISM Program App
- Keywords
- Stress Management
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRISM Program Video CoachBehavioural
Also called Promoting Resilience in Stress Management
A 6-session, skills-based, manualized resilience education program delivered via video coaching by trained English or Spanish speaking PRISM coaches. Participants will have complete access to the PRISM Program mobile app. Sessions will be delivered by a HIPAA compliant videoconferencing platform, Zoom, approximately every 1-2 weeks based on participant preference. For participants who do not have smartphones, temporary equipment will be provided.
PRISM Program Text CoachBehavioural
Also called Promoting Resilience in Stress Management
A 6-session, skills-based, manualized, resilience education program delivered via text coaching by trained English or Spanish speaking PRISM coaches. Participants will have complete access to the PRISM Program mobile app. Sessions will be delivered by HIPAA compliant SMS text-messaging service, Zoom, approximately every other week. For participants who do not have smartphones, temporary equipment will be provided.
mPRISM Program AppBehavioural
Also called Promoting Resilience in Stress Management
6 static modules to practice skills-based, manualized, resilience education program delivered via PRISM Program mobile app. For participants who do not have smartphones, temporary equipment will be provided.
| Study group | Role | What they receive |
|---|---|---|
| PRISM Program Mobile App | Experimental | Participants will be randomized to "app-only" group and will complete:
* Baseline questionnaire.
* mPRISM App self guided modules
* 3 month questionnaire.
* mPRISM App self guided modules until final survey at 6 months and end of participation. Receives: Behavioral: mPRISM Program App |
| PRISM Program Video Coach | Active comparator | Participants will be randomized to "video" group and will complete:
* Baseline questionnaire.
* PRISM sessions.
* 3 month questionnaire with re-randomization to either "app-only" or "text" groups or referral to specialty psychosocial support.
* After re-randomization, participants will complete PRISM sessions until final survey at 6 months and end of participation. Receives: Behavioral: PRISM Program Video Coach; Behavioral: mPRISM Program App |
| PRISM Program Text Coach | Active comparator | Participants will be randomized to "text" group and will complete:
* Baseline questionnaire.
* PRISM sessions.
* 3 month questionnaire with re-randomization to "app-only," "text," or "video" groups.
* After re-randomization, participants will complete PRISM sessions until final survey at 6 months and end of participation. Receives: Behavioral: PRISM Program Text Coach; Behavioral: mPRISM Program App |
What is being measured
The primary outcome is the main question the study is designed to answer.
Connor Davidson Resilience Scale (CDRISC-10) Score
Assessed by the CDRISC-10, a 10-item measures consisting of a 5-point Likert scale with answers ranging from 0 (not true at all) to 4 (true nearly all the time) for a total of 40 points. Higher scores reflect greater resilience. Evaluation will be based on the scores of the video and text cohorts vs. the self-guided cohort.
Measured: At 6 months
Secondary outcomes (8)
CDRISC-10 Score for App-Only Cohort Responders
Assessed by the CDRISC-10, a 10-item measures consisting of a 5-point Likert scale with answers ranging from 0 (not true at all) to 4 (true nearly all the time) for a total of 40 points. Higher scores reflect greater resilience. Participant "responders" are defined as having sustained CDRISC scores >29 after PRISM sessions or increased by >2 points at the timepoints.
Measured: 3 months
CDRISC-10 Score for Text Coach Cohort Responders
Assessed by the CDRISC-10, a 10-item measures consisting of a 5-point Likert scale with answers ranging from 0 (not true at all) to 4 (true nearly all the time) for a total of 40 points. Higher scores reflect greater resilience. Participant "responders" are defined as having sustained CDRISC scores >29 after PRISM sessions or increased by >2 points at the timepoints.
Measured: 3 months
Change in HOPE Scale Score
Assessed by the HOPE Scale, a 12-item measures scored on an 8-point Likert scale with answers ranging from 1 "Definitely False" to 8 "Definitely True" for a total score of 96. A higher score implies a greater level of hopeful thought patterns.
Measured: At Baseline, 3 months, and 6 months
Change in Adolescent Participant Quality of Life Total Score
Assessed by the Pediatric Quality of Life (PedsQL) Generic Core Scales Short Form (SF15) (Teen or Child Report) and PedsQL Cancer Module (Child or Teen Report) scales, 42-items to evaluate health-related quality of life. Items are rated on a 5-point Likert scale with answers ranging from 0 "Never" to 4 "Almost Always" for a score range of 0 - 100. A higher score represents better health-related quality of life.
Measured: At Baseline, 3 months, and 6 months
Change in Young Adult Participant Quality of Life Total Score
Assessed by the Pediatric Quality of Life (PedsQL) Generic Core Scales Short Form (SF15) Young Adult Report and PedsQL Cancer Module Young Adult Report scales, 42-items to evaluate health-related quality of life. Items are rated on a 5-point Likert scale with answers ranging from 0 "Never" to 4 "Almost Always" for a score range of 0 - 100. A higher score represents better health-related quality of life.
Measured: At Baseline, 3 months, and 6 months
Change in Kessler-6 Psychological Distress Scale Score
Assessed by the Kessler-6, a 6-item measure for the level of psychological distress in the past month. Responses are scored on a 5-point Likert scare with answers ranging from 0 "None of the time" to 4 "All of the time," and with a total score range of 0 - 4. Scores > or = 7 suggest "high" distressed and those > or = 13 meet criteria for serious or debilitating psychological distress.
Measured: At Baseline, 3 months, and 6 months
Change in Hospital Anxiety and Depression Scale (HADS) Anxiety Subscale Score
Assessed by the HADS-A subscale which is comprised of 7 items. Items are scored 0-3 with a subscale total score range of 0 - 21. A higher scores represents increasing abnormality (or caseness) for anxiety.
Measured: At Baseline, 3 months, and 6 months
Change in HADS Depression Subscale Score
Assessed by the HADS-D subscale score which is comprised of 7 items. Items are scored 0-3 with a subscale total score range of 0 - 21. A higher score represents increasing abnormality (or caseness) for depression.
Measured: At Baseline, 3 months, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2023
- Study start16 Oct 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 325 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Abby Rosenberg, Dana-Farber Cancer Institute
- Investigators
- Abby Rosenberg, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06038318
- Sponsor's protocol ID
- 22-652
- Other IDs
- R01CA269574-01
- Status last verified
- Dec 2025
- First submitted
- 8 Sep 2023
- Last updated
- 29 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Resilience in Early Survivorship Among Adolescents and Young Adults With Cancer
- ClinicalTrials.gov ID
- NCT06038318
- Acronym / sponsor ID
- 22-652
- Keywords
- Stress Management
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 325 participants (estimated)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 16 Oct 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 14 Sep 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 study is to find the best way to help participants and families manage the stress of facing a serious illness and be better able to "bounce back" or be resilient after a difficult situation. Participants will take part in the "Promoting Resilience in Stress Management" PRISM program, which is designed to provide skills to change or improve the impact of stress in everyday life.
The name of the intervention used in this research study is:
-PRISM (a mobile app program comprised of 6 sessions of skills-based, manualized resilience education)
Detailed description
In this sequential, multiple assignment, randomized trial participants will be randomly selected to participate in PRISM program sessions with a trained research coach either by text or by video sessions, or participants will use the PRISM mobile app program in a self-guided way. Randomization means the group participants are placed in will be decided by chance. All groups will continue to receive all the same care from primary medical, social work, and other care teams.
In this two-stage study, participants will be randomly assigned to either the "app-only" (20% chance), "text" (40% chance) or "video" (40% chance) groups for the first stage. In the second stage, participants may be re-randomized again to the "app-only," or "text," groups, or will be referred to a specialty psychosocial support, social worker or counselor, based on responses to questionnaires. Participants randomized to the "app-only" group in the first stage will not be re-randomized.
The research study procedures include screening for eligibility and completion of questionnaires.
Participation in this research study is expected to last for up to 6 months.
It is expected about 325 people will take part in this research study.
The National Institute for Health (NIH) is funding this research study.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PRISM Program Mobile App | Experimental | Behavioral: mPRISM Program AppParticipants will be randomized to "app-only" group and will complete: * Baseline questionnaire. * mPRISM App self guided modules * 3 month questionnaire. * mPRISM App self guided modules until final survey at 6 months and end of participation. |
| PRISM Program Video Coach | Active comparator | Behavioral: PRISM Program Video Coach, Behavioral: mPRISM Program AppParticipants will be randomized to "video" group and will complete: * Baseline questionnaire. * PRISM sessions. * 3 month questionnaire with re-randomization to either "app-only" or "text" groups or referral to specialty psychosocial support. * After re-randomization, participants will complete PRISM sessions until final survey at 6 months and end of participation. |
| PRISM Program Text Coach | Active comparator | Behavioral: PRISM Program Text Coach, Behavioral: mPRISM Program AppParticipants will be randomized to "text" group and will complete: * Baseline questionnaire. * PRISM sessions. * 3 month questionnaire with re-randomization to "app-only," "text," or "video" groups. * After re-randomization, participants will complete PRISM sessions until final survey at 6 months and end of participation. |
Who may qualify
- Ages
- 12 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- All genders ≥ 12 and ≤ 25 years of age at baseline
- Participant is able to speak English or Spanish language (for PRISM sessions)
- Participant is able to read English or Spanish language (for completion of surveys)
- Participant is cognitively able to participate in PRISM sessions and complete written questionnaires and surveys, as judged by the site investigator
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| PRISM Program Video CoachAlso: Promoting Resilience in Stress ManagementA 6-session, skills-based, manualized resilience education program delivered via video coaching by trained English or Spanish speaking PRISM coaches. Participants will have complete access to the PRISM Program mobile app. Sessions will be delivered by a HIPAA compliant videoconferencing platform, Zoom, approximately every 1-2 weeks based on participant preference. For participants who do not have smartphones, temporary equipment will be provided. | Behavioural | PRISM Program Video Coach |
| PRISM Program Text CoachAlso: Promoting Resilience in Stress ManagementA 6-session, skills-based, manualized, resilience education program delivered via text coaching by trained English or Spanish speaking PRISM coaches. Participants will have complete access to the PRISM Program mobile app. Sessions will be delivered by HIPAA compliant SMS text-messaging service, Zoom, approximately every other week. For participants who do not have smartphones, temporary equipment will be provided. | Behavioural | PRISM Program Text Coach |
| mPRISM Program AppAlso: Promoting Resilience in Stress Management6 static modules to practice skills-based, manualized, resilience education program delivered via PRISM Program mobile app. For participants who do not have smartphones, temporary equipment will be provided. | Behavioural | PRISM Program Mobile App, PRISM Program Text Coach, PRISM Program Video Coach |
Primary outcome
Connor Davidson Resilience Scale (CDRISC-10) Score
Time frame: At 6 months
Assessed by the CDRISC-10, a 10-item measures consisting of a 5-point Likert scale with answers ranging from 0 (not true at all) to 4 (true nearly all the time) for a total of 40 points. Higher scores reflect greater resilience. Evaluation will be based on the scores of the video and text cohorts vs. the self-guided cohort.
8 secondary outcomes
CDRISC-10 Score for App-Only Cohort Responders
Time frame: 3 months
CDRISC-10 Score for Text Coach Cohort Responders
Time frame: 3 months
Change in HOPE Scale Score
Time frame: At Baseline, 3 months, and 6 months
Change in Adolescent Participant Quality of Life Total Score
Time frame: At Baseline, 3 months, and 6 months
Change in Young Adult Participant Quality of Life Total Score
Time frame: At Baseline, 3 months, and 6 months
Change in Kessler-6 Psychological Distress Scale Score
Time frame: At Baseline, 3 months, and 6 months
Change in Hospital Anxiety and Depression Scale (HADS) Anxiety Subscale Score
Time frame: At Baseline, 3 months, and 6 months
Change in HADS Depression Subscale Score
Time frame: At Baseline, 3 months, and 6 months
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 29 Dec 2025.
- Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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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.
Abby Rosenberg, MD principal investigator
Dana-Farber Cancer Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRISM Program Video Coach, PRISM Program Text Coach and mPRISM Program App in people with Stress and Anxiety, run by Dana-Farber Cancer Institute at 2 sites 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 0 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 29 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Abby Rosenberg, MD (206-987-6892, AbbyR_Rosenberg@DFCI.HARVARD.EDU), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Connor Davidson Resilience Scale (CDRISC-10) Score (time frame: At 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Dec 2025.