Preventing Breast Cancer Therapy-related Cardiovascular Toxicity With a Daily-adapted Program With Mhealth Support

Sponsor
Universidad de Granada
Study ID
NCT06518200
Status
Not Yet Recruiting

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Conditions

  • Breast Cancer Female

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Individualised health recommentations — BEHAVIORAL
    Individualised recommendations for physical activity and exercise, lifestyle, stress management and symptom management with solid scientific evidence established by health organisations and scientific reference committeess through the ATOPE-PRO mobile application based on patients reported status.
  • General health recommendations — BEHAVIORAL
    Recommendations for physical activity and exercise, lifestyle, stress management and symptom management with solid scientific evidence established by health organisations and scientific reference committeess through the ATOPE-PRO mobile application.
  • Individualised physical exercise program — BEHAVIORAL
    Follow-up of an individualised exercise program adjusted by daily monitoring of the level of physical, physiological and psychological condition.

Study Details

ATOPE-PRO, was developed with the intention of consolidating the integration of an innovative system for the prevention of cancer therapy-related cardiovascular toxicity (CTR-CVT) in the continuum care of women with breast cancer in health services. It is a step further towards personalized medicine by optimizing the already available tools and integrating artificial intelligence. Breast cancer survival increases every year, a situation that poses new challenges for health professionals. The European Society for Medical Oncology, a reference in Europe, has just highlighted the need to anticipate to and prevent sequelae derived from the disease and its treatments. This, in addition to having a positive impact on improving the quality of life of people suffering from this disease, would mean a reduction in the risk of recurrence, the appearance of other tumors and other diseases, and death from cancer or other causes, which have a personal impact and represent an overload of the healthcare system. To this end, ATOPE- PRO aims to optimize and refine tools already developed in the previous project (ATOPE, Pl18/01840), integrating artificial intelligence to help identify CTR-CVT, risk profiles, and effective and safe doses (at a clinical level) early on, implementing the program in a longer term, and transferring the results to the social sector (social level). The project has 4 stages: Phase 0 or start-up (to make improvements and analyse usability); Phase 1 for piloting and optimization; Phase 2, to verify efficacy (randomized controlled clinical trial) and Phase 3, in which a deep analysis will be performed and future projects will be conceived.

Key Dates

First listed
Jul 24, 2024
Start date
Sep 1, 2026
Status verified
Apr 2026
Primary completion
Dec 30, 2026
Completion
Dec 31, 2028

Study Design

Enrollment
102 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Intervention Group
    Health recommendations (educational videos) + Individualised exercise intervention
  • Other: Control Group
    Health recommendations (educational videos)

Primary Outcome Measure

Cardiotoxicity [ Time Frame: At diagnosis before treatments, after 6 months, and one year after diagnosis. ]

Central Contacts

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