CancerNCT06979843
Evaluation of a Psychosocial Support Model for Adolescents and Young Adults Newly Diagnosed With Cancer
A study testing A psychosocial model in people with Cancer, run by Karolinska Institutet at 2 sites in Sweden.
Trial summary
Rational: Adolescents and young adults (AYAs) newly diagnosed with cancer is a small but vulnerable group with many psychosocial needs persisting for a long time. No standardized psychosocial support program exists for this group of patients in Sweden. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer
- What is being tested?
- A psychosocial model
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 2 sitesSweden
- Study dates
- 16 Jan 2025to Dec 2028
- 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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Participants will be AYAs newly diagnosed with cancer at Karolinska University Hospital and Sahlgrenska University Hospital who have been referred to Team young by their contact nurse.
- Individuals newly diagnosed with cancer, 16-30 years of age who understand and speak Swedish.
- Participants will be all eligible health care professionals, involved in delivering the implemented model of psychosocial support (Team Young and PRISM) at Karolinska University Hospital and Sahlgrenska University Hospital.
Who cannot join
- Any psychiatric disorder or cognitive difficulties.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Jeanette Winterling, PhD, Associate professor, RN contact
Sweden2 sites, 2 recruiting
- Recruiting
Sahlgrenska University Hospital
Gothenburg
Maria Olsson, PhD, RN, +46 722 421695, maria.a.olsson@vgregion.se
- Recruiting
Karolinska University Hospital
Stockholm
Jeanette Winterling, PhD, Associate professor, RN, +46700856552, jeanette.winterling@regionstockholm.se
About this study
Rational:
Adolescents and young adults (AYAs) newly diagnosed with cancer is a small but vulnerable group with many psychosocial needs persisting for a long time. No standardized psychosocial support program exists for this group of patients in Sweden.
Read more
The program:
The program in the present project aims at offering all AYAs, newly diagnosed with cancer, at two Comprehensive Cancer Centres in Sweden, an individual information meeting with a "Team Young" to assess psychosocial needs and then offer available psychosocial support including a structured psychosocial program labelled Promoting Resilience in Stress Management (PRISM). PRISM aims to strengthen key resilience resources such as stress-management, goal setting, cognitive reframing, and meaning-making. It has been developed and evaluated in the US. Evaluations from the US have proven to be promising among AYAs with cancer. PRISM was associated with clinically and statistically significant improvements in resilience, hope, benefit-finding, disease-related quality of life, and reductions in psychological distress, compared to usual care. Our research group has translated and adopted PRISM to a Swedish context with a participatory research approach involving clinicians, researchers, and end-users. The first version of PRISM has been evaluated in a feasibility study and based on the findings revised. A second feasibility study was finalised during 2024 at two Comprehensive Cancer Centers in Sweden with preliminary findings indicating positive experiences from participants. In parallel to this project, comparison data on primary and secondary outcomes, has been collected from the general population in the same age group. The findings indicate so far promising psychometric properties for the main outcome resilience.
Aim:
The overall aim of this research project is to evaluate a psychosocial support program for adolescents and young adults (AYAs) newly diagnosed with cancer. It includes offering all AYAs, newly diagnosed with cancer, an information meeting with a "Team Young" to assess psychosocial needs and then offer available psychosocial support including a structured psychosocial program labelled Promoting Resilience in Stress Management (PRISM).
Method:
The design is a longitudinal cohort study and will include approximately 130 AYAs (16-30 years) newly diagnosed with cancer at Karolinska- and Sahlgrenska University Hospitals. All participants will complete questionnaires on three occasions: at enrolment in PRISM, after 4 modules in PRISM and six months after enrolment. The primary outcome measure is psychological resilience and secondary outcomes are psychological well-being, quality of life and level of hope.
Relevance:
Implementing a structured psychosocial support program for AYAs newly diagnosed with cancer has the potential to mean a lot for each patient and their families and facilitate for health care professionals involved in their cancer care.
If this research project shows promising results on resilience, psychological wellbeing, quality of life and/or hope, PRISM can be implemented as standard care at hospitals in Sweden treating AYAs with cancer.
- Conditions
- Cancer
- Being tested
- A psychosocial model
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A psychosocial modelOther
The first aim is to evaluate if participating in the psychosocial model (including Team Young and PRISM) maintains or improves psychological resilience, psychological wellbeing, quality of life and hope among AYAs at a six-month follow-up, compared to time of diagnosis. The second aim is to evaluate how participants in the model of psychosocial support (including Team Young and PRISM) experience it with regard to acceptability, relevance and benefit.
The design is a longitudinal cohort study.
| Study group | Role | What they receive |
|---|---|---|
| A psychosocial model | Experimental | The first aim is to evaluate if participating in the psychosocial model (including Team Young and PRISM) maintains or improves psychological resilience, psychological wellbeing, quality of life and hope among AYAs at a six-month follow-up, compared to time of diagnosis. The second aim is to evaluate how participants in the model of psychosocial support (including Team Young and PRISM) experience it with regard to acceptability, relevance and benefit. Receives: Other: A psychosocial model |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resilience
The primary outcome, i.e. resilience will be measured with the Connor-Davidson Resilience Scale (CD-RISC-10 items). Score range is 0-40 for CD-RISC-10, with higher scores indicating greater resilience
Measured: Data collection implies all participants to complete questionnaires on three occasions: at enrolment in the study, after module 4 in PRISM (approximately 4-8 weeks after enrolment) and six months after enrolment in PRISM.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2025
- Study start16 Jan 2025
- Primary completionJun 2028 (estimated)
- Study completionDec 2028 (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 Karolinska InstitutetThe 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
- Model description
- The research design follows the framework for developing and evaluating complex interventions, applying a non-randomised design since the project aims at aligning as closely as possible to the clinical practice and everyday routine. Further, when an evidence-based intervention is implemented in another setting to wherein it was previously found to be effective, it is reasonable to evaluate both the intervention as well as the implementation process part. It is essential to include a process evaluation to be able to investigate aspects beyond effectiveness. A process evaluation can shed light on fidelity and quality of implementation, how is change produced and how is context affecting the implementation.
- Masking
- None (open label)
- Enrolment
- 142 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Sophiahemmet University, Vastra Gotaland Region, Region Stockholm
- Responsible party
- Principal investigator, Jeanette Winterling, Region Stockholm
- Investigators
- Jeanette Winterling, Principal investigator, Region Stockholm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06979843
- Sponsor's protocol ID
- Dnr 2024-07540-01
- Status last verified
- Jun 2026
- First submitted
- 6 May 2025
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Odling M, Jervaeus A, Wengstrom Y, Rosenberg AR, Yi-Frazier JP, Winterling J. Adaptation and feasibility of the Swedish Promoting Resilience in Stress Management intervention targeting adolescents and young adults newly diagnosed with cancer. J Psychosoc Oncol. 2025;43(4):513-529. doi: 10.1080/07347332.2024.2419663. Epub 2024 Oct 28.
PubMed 39466132
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Psychosocial Support Model for Adolescents and Young Adults Newly Diagnosed With Cancer
- ClinicalTrials.gov ID
- NCT06979843
- Acronym / sponsor ID
- Dnr 2024-07540-01
- Conditions
- Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 142 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Sophiahemmet University, Vastra Gotaland Region, Region Stockholm
- Study start
- 16 Jan 2025 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 20 May 2025 (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.
Rational:
Adolescents and young adults (AYAs) newly diagnosed with cancer is a small but vulnerable group with many psychosocial needs persisting for a long time. No standardized psychosocial support program exists for this group of patients in Sweden.
The program:
The program in the present project aims at offering all AYAs, newly diagnosed with cancer, at two Comprehensive Cancer Centres in Sweden, an individual information meeting with a "Team Young" to assess psychosocial needs and then offer available psychosocial support including a structured psychosocial program labelled Promoting Resilience in Stress Management (PRISM). PRISM aims to strengthen key resilience resources such as stress-management, goal setting, cognitive reframing, and meaning-making. It has been developed and evaluated in the US. Evaluations from the US have proven to be promising among AYAs with cancer. PRISM was associated with clinically and statistically significant improvements in resilience, hope, benefit-finding, disease-related quality of life, and reductions in psychological distress, compared to usual care. Our research group has translated and adopted PRISM to a Swedish context with a participatory research approach involving clinicians, researchers, and end-users. The first version of PRISM has been evaluated in a feasibility study and based on the findings revised. A second feasibility study was finalised during 2024 at two Comprehensive Cancer Centers in Sweden with preliminary findings indicating positive experiences from participants. In parallel to this project, comparison data on primary and secondary outcomes, has been collected from the general population in the same age group. The findings indicate so far promising psychometric properties for the main outcome resilience.
Aim:
The overall aim of this research project is to evaluate a psychosocial support program for adolescents and young adults (AYAs) newly diagnosed with cancer. It includes offering all AYAs, newly diagnosed with cancer, an information meeting with a "Team Young" to assess psychosocial needs and then offer available psychosocial support including a structured psychosocial program labelled Promoting Resilience in Stress Management (PRISM).
Method:
The design is a longitudinal cohort study and will include approximately 130 AYAs (16-30 years) newly diagnosed with cancer at Karolinska- and Sahlgrenska University Hospitals. All participants will complete questionnaires on three occasions: at enrolment in PRISM, after 4 modules in PRISM and six months after enrolment. The primary outcome measure is psychological resilience and secondary outcomes are psychological well-being, quality of life and level of hope.
Relevance:
Implementing a structured psychosocial support program for AYAs newly diagnosed with cancer has the potential to mean a lot for each patient and their families and facilitate for health care professionals involved in their cancer care.
If this research project shows promising results on resilience, psychological wellbeing, quality of life and/or hope, PRISM can be implemented as standard care at hospitals in Sweden treating AYAs with cancer.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The research design follows the framework for developing and evaluating complex interventions, applying a non-randomised design since the project aims at aligning as closely as possible to the clinical practice and everyday routine. Further, when an evidence-based intervention is implemented in another setting to wherein it was previously found to be effective, it is reasonable to evaluate both the intervention as well as the implementation process part. It is essential to include a process evaluation to be able to investigate aspects beyond effectiveness. A process evaluation can shed light on fidelity and quality of implementation, how is change produced and how is context affecting the implementation.
| Arm | Type | Receives |
|---|---|---|
| A psychosocial model | Experimental | Other: A psychosocial modelThe first aim is to evaluate if participating in the psychosocial model (including Team Young and PRISM) maintains or improves psychological resilience, psychological wellbeing, quality of life and hope among AYAs at a six-month follow-up, compared to time of diagnosis. The second aim is to evaluate how participants in the model of psychosocial support (including Team Young and PRISM) experience it with regard to acceptability, relevance and benefit. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Participants will be AYAs newly diagnosed with cancer at Karolinska University Hospital and Sahlgrenska University Hospital who have been referred to Team young by their contact nurse.
- Individuals newly diagnosed with cancer, 16-30 years of age who understand and speak Swedish.
- Participants will be all eligible health care professionals, involved in delivering the implemented model of psychosocial support (Team Young and PRISM) at Karolinska University Hospital and Sahlgrenska University Hospital.
Key exclusion criteria (1 listed)
- Any psychiatric disorder or cognitive difficulties.
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 |
|---|---|---|
| A psychosocial modelThe first aim is to evaluate if participating in the psychosocial model (including Team Young and PRISM) maintains or improves psychological resilience, psychological wellbeing, quality of life and hope among AYAs at a six-month follow-up, compared to time of diagnosis. The second aim is to evaluate how participants in the model of psychosocial support (including Team Young and PRISM) experience it with regard to acceptability, relevance and benefit. The design is a longitudinal cohort study. | Other | A psychosocial model |
Primary outcome
Resilience
Time frame: Data collection implies all participants to complete questionnaires on three occasions: at enrolment in the study, after module 4 in PRISM (approximately 4-8 weeks after enrolment) and six months after enrolment in PRISM.
The primary outcome, i.e. resilience will be measured with the Connor-Davidson Resilience Scale (CD-RISC-10 items). Score range is 0-40 for CD-RISC-10, with higher scores indicating greater resilience
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 Jun 2026.
- Background: PubMed 39466132Odling M, Jervaeus A, Wengstrom Y, Rosenberg AR, Yi-Frazier JP, Winterling J. Adaptation and feasibility of the Swedish Promoting Resilience in Stress Management intervention targeting adolescents and young adults newly diagnosed with cancer. J Psychosoc Oncol. 2025;43(4):513-529. doi: 10.1080/07347332.2024.2419663. Epub 2024 Oct 28.
- Individual participant dataSharing planned: Undecided
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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.
Jeanette Winterling, PhD, Associate professor, RN contact
Jeanette Winterling principal investigator
Region Stockholm
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A psychosocial model in people with Cancer, run by Karolinska Institutet at 2 sites in Sweden.
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 3 inclusion and 1 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 9 Jun 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 Sweden. 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 Jeanette Winterling, PhD, Associate professor, RN (+46 70-0856552, jeanette.winterling@regionstockholm.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resilience (time frame: Data collection implies all participants to complete questionnaires on three occasions: at enrolment in the study, after module 4 in PRISM (approximately 4-8 weeks after enrolment) and six months after enrolment in PRISM.). 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 NCT06979843, 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 Jun 2026.