跳至主要内容
临床试验/NCT06979843
NCT06979843招募中不适用

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

Karolinska Institutet2 个研究点 分布在 1 个国家目标入组 142 人开始时间: 2025年1月16日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
142
试验地点
2
主要终点
Resilience

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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.

排除标准

  • •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.

研究组 & 干预措施

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.

干预措施: A psychosocial model (Other)

结局指标

主要结局

Resilience

时间窗: 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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jeanette Winterling

Associate professor, registered nurse

Region Stockholm

研究点 (2)

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