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NCT Number: NCT05642897

Mind Programme for Women With Breast Cancer

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.

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Key information

Conditions

Breast Cancer Female Behavior Personal Satisfaction Psychological Well-Being

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Radiotherapy Service of the Coimbra University Hospital (CHUC)

Coimbra, Portugal

Location status: Recruiting

Location contact

Ana Pereira, MScience

CONTACT

[email protected]

Andreia Soares, PhD

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Mind

Behavioral

ACT, mindfulness, and compassion-based intervention

Support group

Behavioral

This intervention promotes the sharing of cancer-related experiences, active listening and a sense of community between participants.

Primary outcomes

  1. Cancer-specific quality of life

    Time frame: Baseline, post-treatment (2 months after baseline), and 6-months follow-up

    EORTC QLQ-C30 - Quality of Life, the higher the score, the higher the QoL level

Secondary outcomes

  1. Psychological flexibility

    Time frame: Baseline, post-treatment (2 months after baseline), and 6-months follow-up

    Comprehensive Assessment of Acceptance and Commitment Therapy's Processes, the higher the score, the higher psychological flexibility level

  2. Self-compassion and mindfulness

    Time frame: Baseline, post-treatment (2 months after baseline), and 6-months follow-up

    Self-compassion Scale, the higher the score, the higher the self-compassion or mindfulness level

  3. Immunological and epigenetic markers

    Time frame: Baseline, post-treatment (2 months after baseline) and 6-months follow-up

    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).

  4. General quality of life

    Time frame: Baseline, post-treatment (2 months after baseline), and 6-months follow-up

    EQ-5D-5L, the higher the score, the higher the QoL level

  5. Major life events questionnaire - controlling variable

    Time frame: 6-months follow-up

    Major Life Event Questionnaire, the higher the score, the higher the number of major life events in the previous year

  6. ACT processes (Hexa(in)Flex Interview)

    Time frame: Baseline

    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.

  7. Consumption of resources and costs

    Time frame: Baseline, post-treatment (2 months after baseline), and 6-months follow-up

    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.

  8. Depressive symptoms and anxiety severity

    Time frame: Baseline, post-treatment (2 months after baseline), and 6-months follow-up

    HADS, the higher the score, the higher anxiety and depression level

Study contacts

Contact information is provided by the study sponsor or research team.

Helena Moreira, PhD

CONTACT

[email protected]

Inês A Trindade, PhD

CONTACT

[email protected]

239851450 ext. 375

Sponsors and collaborators

Lead sponsor

University of Coimbra

Other

Collaborators

  • IPATIMUP - Instituto De Patologia E Imunologia Molecular Da Universidade Do Porto

Registry information

Official study 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

Acronym: MIND

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Dec 8, 2022
Registry last updated
Aug 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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