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

Karolinska Institute

Status: Enrolling

Conditions: Cancer

Treatments: Other: A psychosocial model

Study type: Interventional

Funder types: Other

Identifiers

NCT06979843

Dnr 2024-07540-01

Details and patient eligibility

About

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.

Enrollment: 142 estimated patients

Sex: All

Ages: 16+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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142 participants in 1 patient group

A psychosocial model

Experimental group

Description:

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.

Treatment:

Other: A psychosocial model