The Mind programme for cancer patients was developed by this project PI through the integration of ACT, mindfulness and CFT components specifically adapted to the needs of a cancer population. This intervention aims at improving well-being, preventing subsequent distress, and promoting adaptation to the disease and posttreatment period. A recent pilot study presented preliminary findings on this intervention, suggesting high acceptability and efficacy in improving self-reported psychological health in breast cancer patients undergoing Radiotherapy treatment. Nevertheless, this study's small sample size, methodology (inactive control group), and exclusive reliance on self-reported data limit the interpretation and generalization of results, creating an avenue for the optimization and further testing of the programme through more robust and reliable methods. The aim of this project is therefore to optimize the Mind programme taking into consideration the results from its pilot study and to conduct a Randomized Controlled Trial on the efficacy of the intervention in improving not only mental health outcomes but also biological markers, as well as on its cost-effectiveness, in women with breast cancer. The superiority of the Mind programme will be compared to a support group intervention through the analysis of changes in cancer-specific quality of life, depressive symptoms and anxiety severity, psychological experiences, and immunological and epigenetics markers related to mental health and breast cancer prognosis. All participants will receive the intervention that shows better results.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
150
ACT, mindfulness, and compassion-based intervention
This intervention promotes the sharing of cancer-related experiences, active listening and a sense of community between participants.
Radiotherapy Service of the Coimbra University Hospital (CHUC)
Coimbra, Portugal
RECRUITINGCancer-specific quality of life
EORTC QLQ-C30 - Quality of Life, the higher the score, the higher the QoL level
Time frame: Baseline, post-treatment (2 months after baseline), and 6-months follow-up
Psychological flexibility
Comprehensive Assessment of Acceptance and Commitment Therapy's Processes, the higher the score, the higher psychological flexibility level
Time frame: Baseline, post-treatment (2 months after baseline), and 6-months follow-up
Self-compassion and mindfulness
Self-compassion Scale, the higher the score, the higher the self-compassion or mindfulness level
Time frame: Baseline, post-treatment (2 months after baseline), and 6-months follow-up
Immunological and epigenetic markers
Immunology indicators. Inflammatory biomarkers formerly associated with depression and anxiety (e.g., CRP, IL-6 and TNFalpha); biomarkers of the development of effective immune surveillance (e.g., IFNgamma, IL-12/18, GM-CSF); suppressive cytokines that may block the development of effective anti-tumour immune responses (e.g., IL-10, IL-4/13). Epigenetics indicators. Expression of miRs associated with stress response, inflammation, or BC prognosis (miR-21, miR-146a, miR-155, and miR-Let7).
Time frame: Baseline, post-treatment (2 months after baseline) and 6-months follow-up
General quality of life
EQ-5D-5L, the higher the score, the higher the QoL level
Time frame: Baseline, post-treatment (2 months after baseline), and 6-months follow-up
Major life events questionnaire - controlling variable
Major Life Event Questionnaire, the higher the score, the higher the number of major life events in the previous year
Time frame: 6-months follow-up
ACT processes (Hexa(in)Flex Interview)
Hexa(in)Flex Interview is a semi-structured interview that aims to assess qualitatively the subjective experience of the 6 core processes of the Psychological (In)Flexibility Model underlying ACT in women with breast cancer. The interview has two parts: 1) an introduction to the aims of the interview, as well as introductory questions regarding diagnostic information (e.g., duration of diagnosis, treatment phase, support network) and general coping and adaptation to the cancer diagnosis; 2) Five sections of open questions aiming to assess: experiential avoidance versus acceptance, cognitive fusion versus defusion, conceptual versus contextual self, Past and future conceptualized (auto-pilot) versus contact with present moment, and lack of values clarity and action versus commitment to valued action. Each section has instructions on how the interviewer should conduct the questioning, as well as additional tips and caveats that should be considered.
Time frame: Baseline
Consumption of resources and costs
To collect data regarding resources used by participants outside the hospital setting, the research team developed a questionnaire adapted from the UK Cancer Costs Questionnaire (UKCC) Version 2.0 (http://blogs.ed.ac.uk/ukcc). Hospital costs will be taken from clinical registries.
Time frame: Baseline, post-treatment (2 months after baseline), and 6-months follow-up
Depressive symptoms and anxiety severity
HADS, the higher the score, the higher anxiety and depression level
Time frame: Baseline, post-treatment (2 months after baseline), and 6-months follow-up
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