Clinical trial NCT06979843: Evaluation of a Psychosocial Support Model for Adolescents and Young Adults Newly Diagnosed With Cancer
Official title: Evaluation of a Psychosocial Support Model for Adolescents and Young Adults Newly Diagnosed With Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Sophiahemmet University
name: Vastra Gotaland Region
name: Region Stockholm
First posted: 2025-05-20
Enrollment: 142
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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.

Primary outcomes:
measure: Resilience
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Göteborg
country: Sweden
facility: Sahlgrenska University Hospital
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
Study officials:
affiliation: Region Stockholm
name: Jeanette Winterling
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. 2024 Oct 28:1-17. doi: 10.1080/07347332.2024.2419663. Online ahead of print.