NCT05642897: MIND

Mind Programme for Women With Breast Cancer

Recruiting now NA Last updated 28 August 2024

What this trial tests

NA trial testing Mind in Breast Cancer Female in 150 participants. Currently enrolling.

Timeline

2 January 2023

Primary endpoint
31 May 2025

31 August 2025

Quick facts

Lead sponsor	University of Coimbra
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	150
Start date	2 January 2023
Primary completion	31 May 2025
Estimated completion	31 August 2025
Sites	1 location across Portugal

Drugs / interventions tested

• Mind
• Support Group

Conditions studied

• Breast Cancer Female — all drugs for Breast Cancer Female →

Sponsor

University of Coimbra

Who can join

Adults 18 to 70, female only, with Breast Cancer Female. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Efficacy and cost-effectiveness of an ACT and compassion-based intervention for women with breast cancer: study protocol of two randomised controlled trials {1}.
   Trindade IA, Soares A, Skvarc D, Carreiras D, et al · · 2025 · cited 2× · PMID 39754194 · DOI 10.1186/s13063-024-08626-4