Mind Programme for Women With Breast Cancer

Breast Cancer Female Clinical Trial

— MIND  

Official title:

Mind Programme for Women With Breast Cancer: A Randomized Controlled Trial Testing the Programme´s Cost-effectiveness and Efficacy in Changing Psychological and Biological Outcomes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05642897
• Other study ID #: CINEICC-3-IAT
• Status: Recruiting
• Phase: N/A
• Start date: January 2, 2023
• Est. completion date: August 31, 2025

Study information

• Verified date: January 2024
• Source: University of Coimbra
• Contact: Inês A Trindade, PhD
• Phone: 239851450
• Email: ines.almeidatrindade[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: August 31, 2025
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. age between 18-70;

2. primary diagnosis of BC (stages between I and III);

3. undergoing radiotherapy treatment at CHUC;

4. able to understand and answer to self-report questionnaires in Portuguese.

Exclusion Criteria:

1. currently undergoing any form of psychological intervention;

2. current diagnosis of severe psychiatric illness (psychotic disorder, bipolar disorder, substance abuse, and personality disorder) or suicidal ideation;

3. diagnosis of neurological disease.

Related Conditions & MeSH terms

• Breast Cancer Female
• Breast Neoplasms

Intervention

Behavioral:
• Mind
ACT, mindfulness, and compassion-based intervention
• Support Group
This intervention promotes the sharing of cancer-related experiences, active listening and a sense of community between participants.

Locations

Country	Name	City	State
Portugal	Radiotherapy Service of the Coimbra University Hospital (CHUC)	Coimbra

Sponsors (2)

Lead Sponsor	Collaborator
University of Coimbra	IPATIMUP - Instituto De Patologia E Imunologia Molecular Da Universidade Do Porto

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cancer-specific quality of life	EORTC QLQ-C30 - Quality of Life, the higher the score, the higher the QoL level	Baseline, post-treatment (2 months after baseline), and 6-months follow-up
Secondary	Psychological flexibility	Comprehensive Assessment of Acceptance and Commitment Therapy's Processes, the higher the score, the higher psychological flexibility level	Baseline, post-treatment (2 months after baseline), and 6-months follow-up
Secondary	Self-compassion and mindfulness	Self-compassion Scale, the higher the score, the higher the self-compassion or mindfulness level	Baseline, post-treatment (2 months after baseline), and 6-months follow-up
Secondary	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).	Baseline and 6-months follow-up
Secondary	General quality of life	EQ-5D-5L, the higher the score, the higher the QoL level	Baseline, post-treatment (2 months after baseline), and 6-months follow-up
Secondary	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	6-months follow-up
Secondary	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.	Baseline
Secondary	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.	Baseline, post-treatment (2 months after baseline), and 6-months follow-up
Secondary	Depressive symptoms and anxiety severity	HADS, the higher the score, the higher anxiety and depression level	Baseline, post-treatment (2 months after baseline), and 6-months follow-up