Efficacy and cost-effectiveness of an ACT and compassion-based intervention for women with breast cancer: study protocol of two randomised controlled trials
2025

Mind Programme for Women with Breast Cancer: Study Protocol

Sample size: 150 publication 10 minutes Evidence: moderate

Author Information

Author(s): Inês A. Trindade, Andréia Soares, David Skvarc, Diogo Carreiras, Joana Pereira, Óscar Lourenço, Filipa Sampaio, Bruno de Sousa, Teresa C. Martins, Paula Boaventura, Joana Marta-Simões, Ana Galhardo, Ana Pereira, Bruna Veloso, Lara Palmeira, Sérgio A. Carvalho, Nuno Ferreira, Marcela Matos, Paula Castilho, Ricardo João Teixeira, Marta Viegas, Margarida Borrego, Dinis Tomás Cabral, Inês Félix Pinto, Leonor Santos Martins, Nicholas J. Hulbert-Williams, Helena Moreira

Primary Institution: University of Coimbra

Hypothesis

Women with breast cancer receiving the Mind programme will show increased levels of psychosocial and biological outcomes than those in the control group(s).

Conclusion

The study aims to test the efficacy and cost-effectiveness of the Mind programme, which integrates Acceptance and Commitment Therapy and compassion-based approaches for women with breast cancer.

Supporting Evidence

  • Breast cancer is the most diagnosed cancer in women worldwide.
  • Interventions based on Acceptance and Commitment Therapy (ACT) and compassion-based approaches show promise in improving adjustment and quality of life in people with cancer.
  • The Mind programme aims to prepare women for survivorship by promoting psychological flexibility and self-compassion.
  • A pilot study of the Mind programme has shown acceptability and preliminary efficacy in improving quality of life and psychological health.
  • Both trials will assess cancer-specific quality of life, anxiety and depressive symptoms, and other psychological outcomes.
  • Statistical analyses will be conducted using an intention-to-treat approach.

Takeaway

This study is testing a special program to help women with breast cancer feel better and cope with their illness. It compares this program to other types of support.

Methodology

Participants will be randomly assigned to the Mind programme or a support group intervention, with data collected at baseline, post-treatment, and 6-month follow-up.

Potential Biases

Potential bias due to self-reported data and the reliance on participant adherence to the intervention.

Limitations

High risk of participant dropout and challenges in recruiting patients already overwhelmed with treatment.

Participant Demographics

Women aged 18 to 70 diagnosed with breast cancer, stages I to III.

Digital Object Identifier (DOI)

10.1186/s13063-024-08626-4

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