A Manualised Post-Traumatic Growth Intervention For People With Hematological Cancers In Greece
A Manualised Post-Traumatic Growth Intervention For People With Hematological Cancers In Greece
This clinical trial aims to determine whether a manualised group intervention for people with blood cancers can help them experience positive psychological changes following their diagnosis, known as post-traumatic growth. Participants receiving the intervention will be compared with those receiving usual care and placed on a waiting list. Participants will be randomly allocated to either the group intervention or the usual care/waiting-list group. The study will also explore how this intervention could be implemented within the Greek healthcare system. The study aims to answer the following main questions: (1) Does this psychological group intervention increase post-traumatic growth in people with blood cancers? (2) Does this intervention improve other outcomes, including anxiety, depression, quality of life, psychological well-being, cognitive functioning, distress, illness understanding and routine blood markers? Participants will: (1) Attend nine weekly face-to-face group sessions in Greek, each lasting approximately two hours, with other people living with blood cancers. (2) Receive a detailed manual/workbook covering the session content and be encouraged to use it between sessions. (3) Have the opportunity to participate in an optional outdoor activity of their choice. (4) Complete questionnaires and a brief cognitive assessment before and after the intervention, together with other assessments as required. Participation is voluntary and free of charge. Some participants may experience mild emotional discomfort when discussing their experiences; however, psychological support will be available if needed. The findings will help researchers determine whether this group intervention can support people living with blood cancers and inform the future implementation of similar interventions within the Greek healthcare system.
Hematological cancers and their treatments can significantly affect the body, social interactions, and psychological health of individuals who experience them. However, such traumatic experiences provide individuals with the opportunity to change and experience what is known as post-traumatic growth. Post-traumatic growth is defined as the positive psychological changes that happen after a traumatic life crisis, and in people with cancer has been connected to biopsychosocial variables like quality of life and biomarkers.
The objectives of this non-pharmacological randomized controlled trial with pre-post measures are implemented in two phases. Phase 1 - Post-traumatic growth intervention: (1) Develop a post-traumatic growth intervention manual, (2) Investigate the feasibility of implementing a post-traumatic growth intervention in the Greek healthcare system, (3) Assess the effectiveness of a psychological intervention in increasing post-traumatic growth and other biopsychosocial variables in people with hematological cancers. Phase 2 - Policy recommendations for the Greek healthcare system: (1) Develop best practice guide on the psychosocial support of people with hematological malignancies in Greece, (2) Develop health policy recommendations on the integration of psychosocial interventions in oncological health care in Greece.
In this context, a systematic review and meta-analysis of the literature on the findings of interventions in the post-traumatic development of people with cancer was conducted and published (https://doi.org/10.1002/pon.6241). The conclusions of the meta-analysis (e.g., components, methods) contributed to the development of an intervention manual (that features education, self-reflection, behavioral activation, connecting and sharing with others, processing and coping with trauma, emotional regulation techniques, and an introduction to mindfulness meditation).
Following this, a pilot study (n = 6) was conducted to assess the feasibility and acceptability of the manual in this setting. Participants also shared their views and experiences of the intervention.
What follows is a randomized controlled trial, recruiting from major hospitals and patient societies. Measurements include questionnaires (e.g., quality of life, anxiety, depression) and biomarkers (CRP, hemoglobin, albumin).
Participants in the experimental group (expected n = 40) will participate in 9 weekly group meetings lasting 120 minutes each, for 6-10 people. Participants in the control group will receive usual care without any intervention (expected n = 40), but will be offered the intervention after the main study is completed. Participants will be assessed at baseline and at follow-up intervals, using self-reported questionnaires, a brief cognitive assessment (namely the Montreal Cognitive Assessment) and biomarkers.
This is one of the first randomized controlled trials in post-traumatic growth for people with hematologic cancers and is expected to contribute to the available evidence-based interventions for people with hematologic cancers through publications in peer-reviewed journals.
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Exclusion Criteria: