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

NCT06828614 | Enrolling By Invitation DMC

• 1 other identifier: UV-INV_ETICA-3253850
• Study Type: observational
• Target: 111
• Locations: 1 country
• Sites: 1

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).

Conditions

Breast Cancer

Keywords

Breast cancer; Chemotherapy; Barriers to exercise; Physical activity; Fatigue

Outcome Measures

Primary Outcomes (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).

  Day 1

Secondary Outcomes (12)

• Body composition

  Day 1

• Muscle strength

  Day 1

• Upper limb function

  Day 1.

• Functional capacity

  Day 1.

• Physical activity

  Day 1

Other Outcomes (1)

• Semi-structured interview, Perceived barriers

  Day 1

Study Arms (3)

Pre-chemotherapy

Group 1 will include patients diagnosed with breast cancer who are scheduled to start chemotherapy treatment.

Drug: Chemotherapy

During chemotherapy

Group 2 will include patients with breast cancer who at the time of the study are receiving chemotherapy treatment.

Drug: Chemotherapy

Post-chemotherapy

Group 3 will include patients with breast cancer who have completed chemotherapy treatment 6 months or more ago.

Drug: Chemotherapy

Interventions

Chemotherapy DRUG

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.

During chemotherapy; Post-chemotherapy; Pre-chemotherapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Valencia: lead

Study Sites (1)

Facultat de Fisioteràpia Valncia

Valencia, 46010, Spain

Location

MeSH Terms

Conditions

Breast Neoplasms; Motor Activity; Fatigue

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Behavior; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Physiotherapy

Study Record Dates

• First Submitted: February 4, 2025
• First Posted: February 14, 2025
• Study Start: September 1, 2024
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: February 14, 2025

Record last verified: 2025-02

Locations

ES (1)