hormone-receptor-positive breast cancer (stage I, II, III) breast cancer women on hormonal therapy with aromatase inhibitors
Conditions
Interventions
Brief physical activity counselling program: It comprises 8 sessions (120 minutes each), every fifteen days, addressing the following themes: reasons to change, an introduction to the PAC-WOMAN progra
initial assessments and evolution throughout the weeks. Once every 15 days, a thematic group class will be offered to participants, so that they can experiment and discover new physical activities, an
Sponsors
Lusofona University
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Post-menopausal women, below 70 years old; Histologically confirmed hormone-receptor-positive breast cancer (stage I, II, III); Having initiated aromatase inhibitor hormonal therapy following the primary treatment (surgery, radiotherapy, chemotherapy, etc.), at least 1 month before being enrolled; ECOG-Performance Status 0-1.
Exclusion criteria
Exclusion criteria: Evidence of stage IV cancer or synchronous tumors; Uncontrolled hypertension, cardiac or pulmonary disease; Contraindications to exercise training according to the assistant doctor; Inability to provide informed consent; Expected inability to fulfil the proposed schedule.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Physical activity Physical activity will be objectively measured with a seven-day accelerometer monitoring (Actigraph GT9X). Self-reported physical activity will be measured using the short version of the International Physical Activity Questionnaire Short-Form. The Activity Choice Index (ACI) is employed to assess physically active lifestyle behaviors. [Time Frame: baseline, 4 months (intervention's end), 10 and 16 months] 2.Sedentary Behavior Sedentary behavior will be objectively measured with a seven-day accelerometer monitoring (Actigraph GT9X). Self-reported sedentary behavior (sitting time) will be measured using the short version of the International Physical Activity Questionnaire Short-Form. [Time Frame: baseline, 4 months (intervention's end), 10 and 16 months] 3.Cancer-related Quality of Life Quality of life will be assessed with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) and its breast cancer module (EORTC QLQ-BR23). Five items specifically related to joint, bone, and muscle pain/discomfort, derived from the new EORTC QLQ-BR45, were added provided the specificity of aromatase inhibitors' side effects. [Time Frame: baseline, 4 months (intervention's end), 10 and 16 months] 4.Healthcare Use Healthcare use will be assessed by phone interview 6 months after ending the intervention period. Data will be collected on healthcare resources use during the study period, namely number and type of consultations, drugs, medical tests and exams, in-patient stays and day care sessions. Absenteeism will be assessed using participants' reports of their number of absence days or percentage of normal working hours worked, valued at patients' hourly wage. These resources will then be valued using usual official sources. [Time Frame: 6-month after the end of the intervention] | — |
Secondary
| Measure | Time frame |
|---|---|
| Physical measures: Body composition Body weight, height and BMI. Cardiorespiratory fitness Muscular strength (handgrip and maximal strength) Shoulder mobility/flexibility (angular and linear measures) Physical function Psychosocial measures: Perceived intervention climate will be measured with the Interpersonal Behaviors Questionnaire (IBQ Exercise motivational regulations Basic psychological needs satisfaction/frustration for exercise Affective valence of exercise Exercise Self-Efficacy Scale Self-regulatory skills Subjective pain (intensity and severity) Sleep Quality Body Image Depressive symptoms Psychological well-being | — |
Countries
Europe
Contacts
Public ContactEliana Carraca
Lusofona University Faculty of Physical Education and Sport
Outcome results
None listed