CancerNCT06242964
The PRISM-Social Needs (PRISM-SN) Intervention for Adolescents and Young Adults With Cancer
A study testing Promoting Resilience in Stress Management - Social Needs (PRISM-SN) in people with Cancer and Social Functioning, run by Seattle Children's Hospital at 2 sites in United States.
Trial summary
The goal of this study is to establish feasibility, acceptability, and proof-of-concept of an psychosocial intervention adapted to address social health needs of adolescents and young adults (AYAs) newly diagnosed with cancer. The aims of this study are to: 1. Read more about this study
- Who is it for?
- Ages 12 to 25 years
- Conditions the study is for
- Cancer, Social Functioning, Psychosocial Functioning
- What is being tested?
- Promoting Resilience in Stress Management - Social Needs (PRISM-SN)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 May 2024to 31 Dec 2026
- 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
- Aged 12-25 years
- Diagnosed with new malignancy treated with chemotherapy and/or radiation <6-months
- Able to speak in the English language
- Able to read in the English language
- Cognitively able to participate in intervention sessions and complete surveys
Who cannot join
- Aged <12 or >25 years
- Diagnosed with recurrent malignancy
- Diagnosed with new malignancy >6 months
- Not receiving chemotherapy and/or radiation
- Not able to speak in the English language
- Not able to read in the English language
- Not cognitively able to participate in intervention session or complete surveys
Trial locations and contacts
2 sites in 1 country.
United States2 sites
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224
Seattle Children's
Seattle, Washington, 98105
About this study
Official title: The Promoting Resilience in Stress Management-Social Needs (PRISM-SN) Intervention for Adolescents and Young Adults With Cancer: A Randomized Controlled Trial
The goal of this study is to establish feasibility, acceptability, and proof-of-concept of an psychosocial intervention adapted to address social health needs of adolescents and young adults (AYAs) newly diagnosed with cancer. The aims of this study are to:
- Determine if the Promoting Resilience in Stress Management - Social Needs (PRISM-SN) adapted intervention is feasible and acceptable, defined via program uptake and retention and patient-reported feedback.
- Explore whether PRISM-SN improves social outcomes at 12-week follow-up compared to usual care.
Participants will be randomized to receive usual psychosocial care or the PRISM-SN program. Participants on both arms will complete patient-reported outcome surveys at enrollment and 12-weeks later. Researchers will compare participants who received the PRISM-SN program to those who received usual care to see if the program improves psychosocial outcomes.
Read the detailed description
In this randomized controlled trial, AYAs newly diagnosed with cancer will be recruited from two sites and randomly assigned to receive usual care alone or usual care with the Promoting Resilience in Stress Management - Social Needs (PRISM-SN) adapted program. PRISM-SN is a skill-based behavioral program that includes 4 core modules plus a newly developed social health module. Participants on both arms with complete a standardized patient-reported outcome survey assessing aspects of social and psychological functioning at enrollment and 12-week follow-up.
- Conditions
- Cancer, Social Functioning, Psychosocial Functioning, Coping Skills
- Being tested
- Promoting Resilience in Stress Management - Social Needs (PRISM-SN)
- Medical subject headings
- Neoplasms, Social Adjustment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Promoting Resilience in Stress Management - Social Needs (PRISM-SN)Behavioural
The Promoting Resilience in Stress Management - Social Needs (PRISM-SN) intervention is a brief, skill-based psychosocial program. Five core sessions are delivered one-on-one, 1-2 weeks apart, in-person or via videoconference. Sessions teach evidence-based behavioral skills for managing stress, setting goals, reframing negative thoughts, meaning-making, and connecting with others. Each session lasts <60 minutes and is supported by paper-and-pencil or mobile app-based worksheet(s) for learning and practice. A final review session may be completed individually or with a family member, caregiver, or significant other.
| Study group | Role | What they receive |
|---|---|---|
| PRISM-SN Intervention | Experimental | Skill-based psychosocial program Receives: Behavioral: Promoting Resilience in Stress Management - Social Needs (PRISM-SN) |
| Usual Care | No intervention | Standard psychosocial care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cancer Behavior Inventory - Social Relationship Coping Efficacy (CBI-SCRE) Measure
The Cancer Behavior Inventory - Social Relationship Coping Efficacy measure assesses one's confidence to engage in behaviors that maintain or enhance close social relationships in the context of illness. Ten items are rated 1-10; items are summed, with higher scores reflecting higher social relationship coping efficacy.
Measured: 12-weeks
Secondary outcomes (5)
Multidimensional Scale of Perceived Social Support (MSPSS)
The Multidimensional Scale of Perceived Social Support (MSPSS) is a brief tool designed to measure support from family, friends, and a significant other. It includes 12 items with 4 per subscale. Items are rated on a 7-point Likert scale from 1 (very strongly disagree) to 7 (very strongly agree). It has been validated in both adolescents and adults. Mean scale scores ranging from 1-2.9 can be considered low support; 3-5 considered moderate support; and 5.1-7 considered high support.
Measured: 12-weeks
Snyder Hope Scale
The Snyder Hope Scale contains 8 hope items plus 4 filler questions, and measures the overall perception that one's goals can be met. Each item is scored on an 8-point Likert scale; higher scores imply greater levels of hopeful thought patterns.
Measured: 12-weeks
Patient Reported Outcome Measurement Information System (PROMIS) Pediatric Profile-25 and Family Relationships Subscale
The Pediatric Profile-25 (v2.0) includes 25 items assessing health status across 7 domains: physical function mobility, anxiety, depressive symptoms, fatigue, peer relationships, pain interference, and pain intensity. For this study, we will also include the 4-items pediatric family relationships short-form subscale (v1.0). All items are scored on a 5-point Likert scale except for a single pain intensity item scored on a 10-point scale; higher scores indicate more of each domain. Total raw scores are converted to standardized T-scores with a population mean of 50 and a standard deviation of 10.
Measured: 12-weeks
Connor-Davidson Resilience Scale (CS-RISC)
The Connor-Davidson Resilience Scale (CS-RISC) is a reliable and widely used instrument assessing self-perceived resilience. Scores range from 0-40, with higher scores indicating higher self-perceived resilience.
Measured: 12-weeks
Hospital Anxiety and Depression Scale (HADS)
The Hospital Anxiety and Depression Scale (HADS) assesses mixed affective symptoms in patients with serious illness. The scale includes 7 questions for anxiety and 7 for depression. Each is scored from 0-3 for a total range of 0-21 for each subscale. Clinically relevant symptoms are defined as scores of 8 or higher for both anxiety and depression.
Measured: 12-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2024
- Study start15 May 2024
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Dec 2026 (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
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seattle Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pittsburgh Medical Center
- Responsible party
- Principal investigator, Kaitlyn Fladeboe, Seattle Children's Hospital
- Investigators
- Kaitlyn M Fladeboe, PhD, Principal investigator, Seattle Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06242964
- Sponsor's protocol ID
- STUDY00004509
- Status last verified
- Sep 2026
- First submitted
- 29 Jan 2024
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified participant data may be shared upon request. Investigators interested in conducting additional analyses must request data directly from the PI via written correspondence and obtain and provide verification of institutional review board approval.
Publications
Fladeboe KM, Fredman G, Maurer SH, Zhou C, Bradford MC, Yi-Frazier JP, Salsman JM, Baker KS, Mack MC, Taylor MR, Rosenberg AR. Feasibility and proof-of-concept of a combined resilience and social connection intervention for adolescents and young adults with cancer: a pilot randomized trial protocol. Pilot Feasibility Stud. 2026 Jan 29;12(1):32. doi: 10.1186/s40814-026-01775-0.
PubMed 41612517
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Promoting Resilience in Stress Management-Social Needs (PRISM-SN) Intervention for Adolescents and Young Adults With Cancer: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06242964
- Acronym / sponsor ID
- STUDY00004509
- Conditions
- Cancer, Social Functioning, Psychosocial Functioning, Coping Skills
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Seattle Children's HospitalUniversity, hospital or other
- Collaborators
- University of Pittsburgh Medical Center
- Study start
- 15 May 2024 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 5 Feb 2024 (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 establish feasibility, acceptability, and proof-of-concept of an psychosocial intervention adapted to address social health needs of adolescents and young adults (AYAs) newly diagnosed with cancer. The aims of this study are to:
- Determine if the Promoting Resilience in Stress Management - Social Needs (PRISM-SN) adapted intervention is feasible and acceptable, defined via program uptake and retention and patient-reported feedback.
- Explore whether PRISM-SN improves social outcomes at 12-week follow-up compared to usual care.
Participants will be randomized to receive usual psychosocial care or the PRISM-SN program. Participants on both arms will complete patient-reported outcome surveys at enrollment and 12-weeks later. Researchers will compare participants who received the PRISM-SN program to those who received usual care to see if the program improves psychosocial outcomes.
Detailed description
In this randomized controlled trial, AYAs newly diagnosed with cancer will be recruited from two sites and randomly assigned to receive usual care alone or usual care with the Promoting Resilience in Stress Management - Social Needs (PRISM-SN) adapted program. PRISM-SN is a skill-based behavioral program that includes 4 core modules plus a newly developed social health module. Participants on both arms with complete a standardized patient-reported outcome survey assessing aspects of social and psychological functioning at enrollment and 12-week follow-up.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRISM-SN Intervention | Experimental | Behavioral: Promoting Resilience in Stress Management - Social Needs (PRISM-SN)Skill-based psychosocial program |
| Usual Care | No intervention | –Standard psychosocial care |
Who may qualify
- Ages
- 12 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Aged 12-25 years
- Diagnosed with new malignancy treated with chemotherapy and/or radiation <6-months
- Able to speak in the English language
- Able to read in the English language
- Cognitively able to participate in intervention sessions and complete surveys
Key exclusion criteria (7 listed)
- Aged <12 or >25 years
- Diagnosed with recurrent malignancy
- Diagnosed with new malignancy >6 months
- Not receiving chemotherapy and/or radiation
- Not able to speak in the English language
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 |
|---|---|---|
| Promoting Resilience in Stress Management - Social Needs (PRISM-SN)The Promoting Resilience in Stress Management - Social Needs (PRISM-SN) intervention is a brief, skill-based psychosocial program. Five core sessions are delivered one-on-one, 1-2 weeks apart, in-person or via videoconference. Sessions teach evidence-based behavioral skills for managing stress, setting goals, reframing negative thoughts, meaning-making, and connecting with others. Each session lasts <60 minutes and is supported by paper-and-pencil or mobile app-based worksheet(s) for learning and practice. A final review session may be completed individually or with a family member, caregiver, or significant other. | Behavioural | PRISM-SN Intervention |
Primary outcome
Cancer Behavior Inventory - Social Relationship Coping Efficacy (CBI-SCRE) Measure
Time frame: 12-weeks
The Cancer Behavior Inventory - Social Relationship Coping Efficacy measure assesses one's confidence to engage in behaviors that maintain or enhance close social relationships in the context of illness. Ten items are rated 1-10; items are summed, with higher scores reflecting higher social relationship coping efficacy.
5 secondary outcomes
Multidimensional Scale of Perceived Social Support (MSPSS)
Time frame: 12-weeks
Snyder Hope Scale
Time frame: 12-weeks
Patient Reported Outcome Measurement Information System (PROMIS) Pediatric Profile-25 and Family Relationships Subscale
Time frame: 12-weeks
Connor-Davidson Resilience Scale (CS-RISC)
Time frame: 12-weeks
Hospital Anxiety and Depression Scale (HADS)
Time frame: 12-weeks
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 9 Sep 2026.
- Derived from this study: PubMed 41612517Fladeboe KM, Fredman G, Maurer SH, Zhou C, Bradford MC, Yi-Frazier JP, Salsman JM, Baker KS, Mack MC, Taylor MR, Rosenberg AR. Feasibility and proof-of-concept of a combined resilience and social connection intervention for adolescents and young adults with cancer: a pilot randomized trial protocol. Pilot Feasibility Stud. 2026 Jan 29;12(1):32. doi: 10.1186/s40814-026-01775-0.
- Individual participant dataSharing planned: Yes. De-identified participant data may be shared upon request. Investigators interested in conducting additional analyses must request data directly from the PI via written correspondence and obtain and provide verification of institutional review board approval.
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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.
Kaitlyn M Fladeboe, PhD principal investigator
Seattle Children's Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Promoting Resilience in Stress Management - Social Needs (PRISM-SN) in people with Cancer and Social Functioning, run by Seattle Children's Hospital 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 5 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 9 Sep 2026. 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?
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?
Cancer Behavior Inventory - Social Relationship Coping Efficacy (CBI-SCRE) Measure (time frame: 12-weeks). 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 NCT06242964, 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 9 Sep 2026.