Evaluation of a Psychosocial Support Model for Adolescents and Young Adults Newly Diagnosed With Cancer

NCT06979843 | Recruiting

• 1 other identifier: Dnr 2024-07540-01
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 2

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.

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

• 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

  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.

Study Arms (1)

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.

Other: A psychosocial model

Interventions

A psychosocial model OTHER

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.

A psychosocial model

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \- Any psychiatric disorder or cognitive difficulties.
• \- 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.

Sponsors & Collaborators

• Karolinska Institutet: lead
• Sophiahemmet University: collaborator
• Vastra Gotaland Region: collaborator
• Region Stockholm: collaborator

Study Sites (2)

Sahlgrenska University Hospital

Gothenburg, Sweden

RECRUITING

Karolinska University Hospital

Stockholm, Sweden

RECRUITING

Related Publications (1)

• 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.

  PMID: 39466132 BACKGROUND

MeSH Terms

Conditions

Neoplasms

Study Officials

• Jeanette Winterling

  Region Stockholm

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeanette Winterling, PhD, Associate professor, RN

CONTACT

+46 70-0856552; jeanette.winterling@regionstockholm.se

Anna Jervaeus, PhD, Associate Professor, RN

CONTACT

+46 70 264 2039; anna.jervaeus@ki.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor, registered nurse

Model Details: 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.

Study Record Dates

• First Submitted: May 6, 2025
• First Posted: May 20, 2025
• Study Start: January 16, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 20, 2025

Record last verified: 2025-05

Locations

SE (2)