Mind Programme for Women With Breast Cancer
ConditionBreast Cancer Female
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorUniversity of Coimbra
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
age between 18-70;
primary diagnosis of BC (stages between I and III);
undergoing radiotherapy treatment at CHUC;
able to understand and answer to self-report questionnaires in Portuguese.
Disqualifiers
currently undergoing any form of psychological intervention;
current diagnosis of severe psychiatric illness (psychotic disorder, bipolar disorder, substance abuse, and personality disorder) or suicidal ideation;
diagnosis of neurological disease.
Trial design
Design model
Parallel
Treatments tested in this trial
Mind
BehavioralACT, mindfulness, and compassion-based intervention
Support Group
BehavioralThis intervention promotes the sharing of cancer-related experiences, active listening and a sense of community between participants.
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: MindExperimental treatment 1 intervention
Group B: Support groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Cancer-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-upSecondary outcomes
1
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-up2
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-up3
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-up4
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-upSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Coimbra
Lead sponsor
IPATIMUP - Instituto De Patologia E Imunologia Molecular Da Universidade Do Porto
Collaborator
Source ClinicalTrials.gov