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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.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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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.

Spain1 site
  • Facultat de Fisioteràpia Valncia

    Valencia, 46010

Other trials in Spain

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 groups in NCT06828614
Study groupRoleWhat they receive
Pre-chemotherapyGroup 1 will include patients diagnosed with breast cancer who are scheduled to start chemotherapy treatment.
Receives: Drug: Chemotherapy
During chemotherapyGroup 2 will include patients with breast cancer who at the time of the study are receiving chemotherapy treatment.
Receives: Drug: Chemotherapy
Post-chemotherapyGroup 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.

  1. 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)
  1. 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

  2. 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

  3. 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.

  4. 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.

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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.

  1. First posted14 Feb 2025
  2. Study start1 Sep 2024
  3. Primary completionApr 2025 (estimated)
  4. Study completionApr 2025 (estimated)

Resources

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)
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

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.

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