NCT06979843 Evaluation of a Psychosocial Support Model for Adolescents and Young Adults Newly Diagnosed With Cancer
| NCT ID | NCT06979843 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Karolinska Institutet |
| Condition | Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 142 participants |
| Start Date | 2025-01-16 |
| Primary Completion | 2028-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 142 participants in total. It began in 2025-01-16 with a primary completion date of 2028-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
Inclusion Criteria for patients: * 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. Exclusion criteria for patients: \- Any psychiatric disorder or cognitive difficulties. Inclusion criteria for health care professionals: \- 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.
Contact & Investigator
Jeanette Winterling, PhD, Associate professor, RN
✉ jeanette.winterling@regionstockholm.se📞 +46 70-0856552
Jeanette Winterling
PRINCIPAL INVESTIGATOR
Region Stockholm
Frequently Asked Questions
Who can join the NCT06979843 clinical trial?
This trial is open to participants of all sexes, aged 16 Years or older, studying Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06979843 currently recruiting?
Yes, NCT06979843 is actively recruiting participants. Contact the research team at jeanette.winterling@regionstockholm.se for enrollment information.
Where is the NCT06979843 trial being conducted?
This trial is being conducted at Gothenburg, Sweden, Stockholm, Sweden.
Who is sponsoring the NCT06979843 clinical trial?
NCT06979843 is sponsored by Karolinska Institutet. The principal investigator is Jeanette Winterling at Region Stockholm. The trial plans to enroll 142 participants.
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