Breast CancerNCT06828614
Barriers to Therapeutic Exercise in Breast Cancer Patients Before, During, and After Chemotherapy
An observational study of Breast Cancer, run by University of Valencia at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Chemotherapy
- How many people
- 111 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2024to Apr 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluation of the Barriers to Therapeutic Exercise Perceived by People With Breast Cancer Who Are Undergoing Chemotherapy in an Observational Study
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.
Read more
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).
- Conditions
- Breast Cancer
- Being tested
- Chemotherapy
- Keywords
- Breast cancer, Chemotherapy, Barriers to exercise, Physical activity, Fatigue
- Medical subject headings
- Breast Neoplasms, Motor Activity, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChemotherapyDrug
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 the previous study in group 1 (pre-chemotherapy) will be followed up. Patients will receive three assessments of the variables detailed in the following section: 1) during the time prior to the start of chemotherapy (assessment that will coincide with study 1), 2) assessment during chemotherapy treatment and, 3) assessment after the end of chemotherapy treatment.
| Study group | Role | What they receive |
|---|---|---|
| Pre-chemotherapy | Group 1 will include patients diagnosed with breast cancer who are scheduled to start chemotherapy treatment. Receives: Drug: Chemotherapy | |
| During chemotherapy | Group 2 will include patients with breast cancer who at the time of the study are receiving chemotherapy treatment. Receives: Drug: Chemotherapy | |
| Post-chemotherapy | Group 3 will include patients with breast cancer who have completed chemotherapy treatment 6 months or more ago. Receives: Drug: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cancer-related fatigue
It will be evaluated with the Spanish version of the self-reported Piper Fatigue Scale. It presents 22 items and includes four dimensions related to subjective fatigue (behavioral, affective, sensory and cognitive). Scores are between 0 and 10, the higher the total score the greater the disability (0 = no fatigue, 1-3 = mild fatigue, 4-6 = moderate fatigue, 7-10 = severe fatigue).
Measured: Day 1
Secondary outcomes (12)
Body composition
It will be evaluated by means of a scale (TANITA BC-351, Japan). It uses the different impedances of the conductive and isolated parts of the body, allowing to calculate the weight (Kq). Weight and height will be combined to report BMI in kg/m^2)
Measured: Day 1
Muscle strength
The hand grip strength test will be evaluated with a digital dynamometer (Jamar Plus+ digital hand dynamometer (Patterson Medical, Sammons Preston, Bolingbrook, IL, USA)). The patient will be placed in a seated position with the shoulder in adduction and neutral rotation, the elbow flexed at 90º and the forearm and wrist in neutral position. The maximum grip strength will be measured alternately three times on each arm, and the mean of the three measurements will be recorded.
Measured: Day 1
Upper limb function
It will be evaluated using the Disability of Arm, Shoulder and Hand (DASH) questionnaire. It is a scale of 30 items, of which 21 refer to the degree of difficulty in performing physical activities, 5 refer to the severity of some pain symptoms and 5 refer to other activities. The score ranges from 0 to 100 points, the higher the score the greater the disability.
Measured: Day 1.
Functional capacity
It will be assessed by the 6-minute walk test (6MWT) on a treadmill. It determines the maximum distance a person can walk in 6 minutes. It will also include the 30 sec Sit to Stand test, which evaluates how many times the patient is able to stand and sit in a chair, with arms crossed over the chest, for 30 seconds.
Measured: Day 1.
Physical activity
This will be recorded by means of the International Physical Activity Questionnaire (IPAQ), which will allow patients to be divided according to their level of physical activity as high, moderate and low or inactive. Information on physical activity will also be collected by means of a physical activity diary, in which each patient will record the last seven days of physical activity, type of activity, intensity, duration and perceived level of fatigue.
Measured: Day 1
Self-efficacy for physical activity
The Self-Efficacy for Physical Activity Scale (EAF) will be used, which addresses patients' beliefs about their own abilities to perform physical activities. It allows the identification of barriers and limitations that prevent the patient from engaging in regular physical activity. It presents three domains (programmed physical exercise, physical activity in daily activities and walking), which include 39 items, scored from 0 to 10, with a higher score indicating a greater capacity to perform physical activity.
Measured: Day 1
Leisure time physical activity
This will be assessed using the abbreviated version of the Minnesota Leisure Time Physical Activity Questionnaire (VREM). It is composed of 5 items, asking about the period of a typical week in which participants perform routine household activities, as well as activities performed during the last month (e.g. walking, stair climbing, sports, dancing etc.). Gastro-energy in METs/min is calculated and the patient is classified from sedentary to very active.
Measured: Day 1
Physical fitness
The Spanish version of the International Fitness Scale (IFIS) will be used, which measures general physical confidence, cardiorespiratory confidence, muscular strength, speed/agility and flexibility in comparison with the fitness level of a friend. It is scored on a Likert scale from very poor to very good.
Measured: Day 1
Quality of life (EORT QLQ-BR23)
It will be assessed using the Breast Specific Quality of Life Questionnaire by the European Organisation for Research and Treatment of Breast Cancer (EORT QLQ-BR23). It contains 23 items, rated on a four-point scale ranging from 1 (not at all) to 4 (very much), assessing treatment side effects, arm symptoms, body image symptoms and sexual function. Scores range from 0 to 100 points.
Measured: Day 1
Mood
It will be evaluated by means of the Spanish version of the Mood Evaluation Scale (EVEA). This questionnaire evaluates mood through 16 items, scored from 0 to 10 and divided into four categories (sadness-depression, anxiety, danger-hostility and happiness).
Measured: Day 1
Kinesiophobia
It will be evaluated by means of the Spanish validation of the fear avoidance components scale (FACS-Sp). The questionnaire consists of 20 items evaluated on a 6-point Likert scale, where 0 indicates "strongly disagree" and 5 indicates "strongly agree". It has a maximum score of 100 points, with higher scores indicating more entrenched fear avoidance beliefs. Severity levels are classified as follows: subclinical (0-20), mild (21-40), moderate (41-60), severe (61-80) and extreme (81-100).
Measured: Day 1
Anxiety and depression
It will be assessed using the Hospital Anxiety and Depression Scale (HADS). It consists of 14 items with two subscales, seven items assess anxiety and seven assess depression. The score of each subscale ranges from 0 to 21 points and a cut-off point equal to or higher than 11 points has been established to consider anxiety and depression states.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2025
- Study start1 Sep 2024
- Primary completionApr 2025 (estimated)
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 111 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SARA CORTES AMADOR, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06828614
- Sponsor's protocol ID
- UV-INV_ETICA-3253850
- Status last verified
- Feb 2025
- First submitted
- 4 Feb 2025
- Last updated
- 14 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Barriers to Therapeutic Exercise Perceived by People With Breast Cancer Who Are Undergoing Chemotherapy in an Observational Study
- ClinicalTrials.gov ID
- NCT06828614
- Acronym / sponsor ID
- UV-INV_ETICA-3253850
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, Chemotherapy, Barriers to exercise, Physical activity, Fatigue
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 111 participants (estimated)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 14 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pre-chemotherapy | – | Drug: ChemotherapyGroup 1 will include patients diagnosed with breast cancer who are scheduled to start chemotherapy treatment. |
| During chemotherapy | – | Drug: ChemotherapyGroup 2 will include patients with breast cancer who at the time of the study are receiving chemotherapy treatment. |
| Post-chemotherapy | – | Drug: ChemotherapyGroup 3 will include patients with breast cancer who have completed chemotherapy treatment 6 months or more ago. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ChemotherapyThe 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 the previous study in group 1 (pre-chemotherapy) will be followed up. Patients will receive three assessments of the variables detailed in the following section: 1) during the time prior to the start of chemotherapy (assessment that will coincide with study 1), 2) assessment during chemotherapy treatment and, 3) assessment after the end of chemotherapy treatment. | Drug | During chemotherapy, Post-chemotherapy, Pre-chemotherapy |
Primary outcome
Cancer-related fatigue
Time frame: Day 1
It will be evaluated with the Spanish version of the self-reported Piper Fatigue Scale. It presents 22 items and includes four dimensions related to subjective fatigue (behavioral, affective, sensory and cognitive). Scores are between 0 and 10, the higher the total score the greater the disability (0 = no fatigue, 1-3 = mild fatigue, 4-6 = moderate fatigue, 7-10 = severe fatigue).
12 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by University of Valencia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 14 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cancer-related fatigue (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2025.