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Enrolling by invitation NCT06828614

Barriers to Therapeutic Exercise in Breast Cancer Patients Before, During, and After Chemotherapy

Observational Breast Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Chemotherapy.
Who it may be relevant to
Registry conditions: Breast Cancer. Basic parameters: 18 years — 65 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Evaluation of the Barriers to Therapeutic Exercise Perceived by People With Breast Cancer Who Are Undergoing Chemotherapy in an Observational Study

Overview

Cancer is one of the leading causes of mortality. First-choice cancer treatments, such as chemotherapy, have increased the survival of people with cancer, although they are not without adverse effects such as cardiotoxicity, fatigue, nausea, mental health problems or musculoskeletal disorders. Therapeutic exercise is a safe and effective intervention that has shown positive results in the oncology population when implemented as an adjuvant to chemotherapy, during or after chemotherapy. Exercise improves cardiorespiratory capacity, fatigue, strength, anxiety, depressive symptoms and quality of life, among others, in cancer patients. In the implementation of therapeutic exercise in the oncologic population undergoing chemotherapy treatment, it is necessary to take into account possible barriers related to the perception of therapeutic exercise, as well as the side effects derived from chemotherapy. It is necessary to know the barriers to the implementation of exercise in order to address them and favor patients' adherence to exercise programs. The objective is to identify the barriers (physical, contextual and emotional) that may influence people with breast cancer who are in the pre-, concurrent or post-treatment phase, respectively, of chemotherapy treatment for the implementation of therapeutic exercise. The study participants (n=111) will be distributed in the study groups according to the moment of chemotherapy treatment they are in (1: pre-chemotherapy, 2: during chemotherapy, 3: post-chemotherapy).

Interventions

  • Drug Chemotherapy
    The present approved ethics committee includes the conduct of two studies. In the first one, a cross-sectional study, breast cancer patients will be distributed in the study groups according to the moment of their chemotherapy treatment (group 1: pre-chemotherapy, group 2: during chemotherapy, group 3: post-chemotherapy). Each patient will undergo a single evaluation session, which will include the variables detailed in the following section. In the second, a longitudinal study, patients from t

Primary outcome measures

  • Cancer-related fatigue [Time frame: Day 1]
Secondary outcome measures (12)
  • Body composition [Time frame: Day 1]
  • Muscle strength [Time frame: Day 1]
  • Upper limb function [Time frame: Day 1.]
  • Functional capacity [Time frame: Day 1.]
  • Physical activity [Time frame: Day 1]
  • Self-efficacy for physical activity [Time frame: Day 1]
  • Leisure time physical activity [Time frame: Day 1]
  • Physical fitness [Time frame: Day 1]
  • Quality of life (EORT QLQ-BR23) [Time frame: Day 1]
  • Mood [Time frame: Day 1]
  • Kinesiophobia [Time frame: Day 1]
  • Anxiety and depression [Time frame: Day 1]

Eligibility criteria

Inclusion criteria

  • Women over 18 years of age with a diagnosis of breast cancer, stages I to IIIa.
  • The sample will be distributed to three groups according to the time of treatment in which the patients are: a) patients diagnosed with breast cancer scheduled to start chemotherapy treatment, b) patients who at the time of the study are receiving chemotherapy and c) patients who have completed chemotherapy treatment 6 months ago or more.

Exclusion criteria

  • Women with breast cancer relapse and/or other types of cancer.
  • Patients who are receiving hormonal therapy at the time of evaluation.
  • Patients presenting metastatic processes or any other relevant disease.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

Spain · 1 center
  • Facultat de Fisioteràpia Valncia — Valencia

Identifiers

NCT: NCT06828614 · UV-INV_ETICA-3253850

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗