Home-Based Exercise Program During Neoadjuvant Treatment to Improve Fatigue and Quality of Life in Early HER2-Positive and Triple-Negative Breast Cancer Patients

NAActive, not recruitingINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

April 1, 2024

Primary Completion Date

March 31, 2026

Study Completion Date

September 30, 2026

Conditions
Triple Negative Breast Cancer (TNBC)HER2-Positive Breast CancerEarly Breast CancerCancer-related FatigueQuality of Life (QOL)
Interventions
BEHAVIORAL

Home-based exercise program

"The home-based program follows the National recommendations on Physical Exercise for Cancer Patients \[Bruno RC, 2023\]. It is logbook-guided and technology-enabled.~It consists of:~* Two initial supervised explanatory sessions, in the Physic and Rehabilitation Medicine Gym of our institution.~* Followed by 2 muscular training sessions + 3 additional periods of aerobic exercise per week in their home environment until the end of neoadjuvant treatment. Patients are given a logbook with instructions and a sports bracelet for heart rate monitoring.~The training sessions will be monitored by smartwatch heart rate measurements and self-notion of effort according to Borg Categorization \[Borg GA, 1982\] and recorded by the participants in the Mi Fitness application or an Exercise Diary.\[Nilsen TS, 2018\]"

BEHAVIORAL

Promotion of Healthy Physical Activity

"The short counseling consists of at least one opportunistic talk for promotion of physical activity, taking up to 5 minutes, during the Medical Oncology appointment or during Physical Assessments at T0. It should follow the instructions of the Portuguese Directorate-General of Health, Short Counselling for the Promotion of Physical Activity, including the delivery of a Physical Activity Guide plus a Auxiliar of Decision or a Plan of Action or Maintenance.\[Mendes R, 2020\] All patients will receive a Guide about Nutrition for Cancer Patients \[Capela AM, 2023\] and may be offered Nutritional, Psychological or other additional consultations according to clinical judgement of the Medical Oncologist."

Trial Locations (1)

4099-001

Centro Hospitalar Universitário de Santo António, Unidade Local de Saúde de Santo António, Porto

All Listed Sponsors
collaborator

Oncology Research, Unit for Multidisciplinary Research in Biomedicine (UMIB), ICBAS-School of Medicine and Biomedical Sciences, University of Porto, Portugal

UNKNOWN

collaborator

Centro Hospitalar Universitário de Santo António, Unidade Local de Saúde de Santo António, Porto, Portugal

UNKNOWN

lead

Centro Hospitalar Universitário de Santo António

OTHER

NCT06782698 - Home-Based Exercise Program During Neoadjuvant Treatment to Improve Fatigue and Quality of Life in Early HER2-Positive and Triple-Negative Breast Cancer Patients | Biotech Hunter | Biotech Hunter