Clinical trial NCT06828614: Barriers to Therapeutic Exercise in Breast Cancer Patients Before, During, and After Chemotherapy
Official title: Evaluation of the Barriers to Therapeutic Exercise Perceived by People With Breast Cancer Who Are Undergoing Chemotherapy in an Observational Study
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Breast Cancer
Keywords: Breast cancer
Chemotherapy
Barriers to exercise
Physical activity
Fatigue
Lead sponsor: University of Valencia
Sponsor class: OTHER
First posted: 2025-02-14
Enrollment: 111
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women over 18 years of age diagnosed with breast cancer, stages I to IIIa. The patients in the sample must be in one of the following conditions: a) patients diagnosed with breast cancer with scheduled initiation of chemotherapy treatment, b) patients who at the time of the study are receiving chemotherapy and c) patients who have completed chemotherapy treatment 6 months or more ago.

Brief summary: 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).


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.

Primary outcomes:
measure: Cancer-related fatigue
timeFrame: Day 1
Secondary outcomes:
measure: Body composition
timeFrame: Day 1
measure: Muscle strength
timeFrame: Day 1
measure: Upper limb function
timeFrame: Day 1.
measure: Functional capacity
timeFrame: Day 1.
measure: Physical activity
timeFrame: Day 1
measure: Self-efficacy for physical activity
timeFrame: Day 1
measure: Leisure time physical activity
timeFrame: Day 1
measure: Physical fitness
timeFrame: Day 1
measure: Quality of life (EORT QLQ-BR23)
timeFrame: Day 1
measure: Mood
timeFrame: Day 1
measure: Kinesiophobia
timeFrame: Day 1
measure: Anxiety and depression
timeFrame: Day 1
Other outcomes:
measure: Semi-structured interview, Perceived barriers
timeFrame: Day 1
Locations:
city: Valencia
country: Spain
facility: Facultat de Fisioteràpia Valncia
Study officials:
References: