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Evaluate Impact of Exercise Program on Fatigue in Breast Cancer During Chemotherapy

Reclutando
Los detalles del ensayo clínico están disponibles principalmente en inglés. ¡Sin embargo, IA Trial Radar puede ayudar! Simplemente haga clic en 'Explicar el ensayo' para ver y discutir la información del ensayo en el idioma que haya seleccionado.
El estudio clínico NCT05704842 es un ensayo intervencionista para Cáncer de mama. Su estado actual es: reclutando. El ensayo se inició el 22 de diciembre de 2022, con el objetivo de reclutar a 40 participantes. Dirigido por Virtua Health, Inc., se espera que finalice el 1 de junio de 2026. Los datos se actualizaron por última vez en ClinicalTrials.gov el 5 de abril de 2024.
Resumen
Assess feasibility of home exercise in reducing fatigue in subjects with breast cancer receiving curative intent chemotherapy. Subjects are randomized to control (no exercise) or intervention group (exercise). The PRO-CTCAE tool and FACIT Fatigue Scale are used to collect patient reported outcomes. Subjects submit data via mobile phone, tablet or computer. Assessments are weekly during chemotherapy (10-20 wks), at end of chemotherapy and 1, 3 and 6 months after chemotherapy.
Descripción detallada

The goal of this project is to determine the feasibility of a specific home-based exercise intervention in reducing cancer-related fatigue (CRF) in breast cancer patients undergoing curative-intent chemotherapy. The outcome will be measured by using the FACIT Fatigue Scale, administered by using the Carevive PROmpt® platform.

Primary Objectives:

  1. . To examine the feasibility of recruitment and retention of women undergoing treatment for breast cancer over the duration of the chemotherapy regimen.
  2. To examine the adherence to the exercise regime for those in the intervention group and compare the retention rates between treatment and control groups
  3. To compute the means and standard deviations (SD) of the FACIT responses over time in both groups for use in future power analyses to aid in the design of a futre hypothesis testing RCT.

Secondary Objectives:

  1. To quantify the change over time in PRO-CTCAE derived symptoms and other PROs by computing means and SD.
  2. To test for group differences in the trajectory of change over time in FACT using a Mixed Model repeated analysis
Título oficial

Pilot Study to Evaluate the Impact of a Home-Based Exercise Program on Cancer-Related Fatigue in Breast Cancer Patients Undergoing Curative-Intent Chemotherapy

Condiciones médicas
Cáncer de mama
Otros ID del ensayo
  • IRB-2021-04
Número del NCT
NCT05704842
Inicio del ensayo (real)
2022-12-22
Última actualización
2024-04-05
Fecha de finalización (estimada)
2026-06-01
Inscripción (prevista)
40
Tipo de estudio
Intervencionista
FASE
N/A
Estado general
Reclutando
Objetivo principal
Otros
Método de asignación
Aleatorizado
Modelo de intervención
Factorial
Enmascaramiento
Ninguno (Etiqueta abierta)
Brazos / Intervenciones
Grupo de participantesIntervención/Tratamiento
OtrosExercise
Intervention: Subject will be assessed by a Physical Therapist. Based on the assessment, the Physical Therapist will provide the patient with a home-based exercise program including core exercises as follows: Core Stabilization, core extension, leg extensions, squats with and without weights, shoulder and arm exercises. Patients will be asked to complete a symptom survey weekly via a web-based platform for tracking cancer and treatment-related symptoms and fatigue.
Ejercicio
Home-based exercise program including core exercises as follows: Core Stabilization, core extension, leg extensions, squats with and without weights, shoulder and arm exercises.
Sin intervenciónControl
Subject will not be provided an exercise program but will be asked to complete the symptom survey weekly via a web-based platform for tracking cancer and treatment-related symptoms and fatigue.
N/A
Resultado primario
Medida de resultadoDescripción de la medidaPeriodo de tiempo
Determine the feasibility of a specific home-based exercise program in reducing cancer-related fatigue.
The outcome will be measured by using the FACIT Fatigue Scale 0 - 4. 0 = (not at all) 1= (a little bit) 2 = (somewhat) 3 = (Quite a bit), 4 = (Very much).
Baseline
Determine the feasibility of a specific home-based exercise program in reducing cancer-related fatigue.
Changes in fatigue will be assessed, this outcome will be measured by using the FACIT Fatigue Scale, 0 - 4. 0 = (not at all) 1= (a little bit) 2 = (somewhat) 3 = (Quite a bit), 4 = (Very much).
Weekly for 12 weeks
Determine the feasibility of a specific home-based exercise program in reducing cancer-related fatigue.
Changes in fatigue will be assessed this outcome will be measured by using the FACIT Fatigue Scale, 0 - 4. 0 = (not at all) 1= (a little bit) 2 = (somewhat) 3 = (Quite a bit), 4 = (Very much).
Month 1 following completion of chemotherapy
Determine the feasibility of a specific home-based exercise program in reducing cancer-related fatigue.
Changes in fatigue will be assessed, this outcome will be measured by using the FACIT Fatigue Scale, 0 - 4. 0 = (not at all) 1= (a little bit) 2 = (somewhat) 3 = (Quite a bit), 4 = (Very much).
Month 3 following completion of chemotherapy
Determine the feasibility of a specific home-based exercise program in reducing cancer-related fatigue.
Changes in fatigue will be assessed this outcome will be measured by using the FACIT Fatigue Scale, 0 - 4. 0 = (not at all) 1= (a little bit) 2 = (somewhat) 3 = (Quite a bit), 4 = (Very much).
Month 6 following completion of chemotherapy
Resultado secundario
Medida de resultadoDescripción de la medidaPeriodo de tiempo
To quantify the change over time in PRO-CTCAE derived symptoms
Outcome will be measured using PRO-CTCAE Derived Symptoms and other PROs. A scale Yes or No is utilized to describe whether the following symptoms have been experienced: Anxiety, constipation, decreased appetite, diarrhea, fatigue, general pain, insomnia, mouth sores, muscle pain, nausea, numbness and tingling, problems and concentration, rash, sad, shortness of breath, vomiting. The following sale: Rarely, occasionally, frequently or almost constantly will be used to measure anxiety and general pain. Severity of the following symptoms: Anxiety, fatigue, general pain and problems with concentration in a 7 day time period will be measured using the following scale: Mild, Moderate, Severe, Very Severe.
Baseline
To quantify the change over time in PRO-CTCAE derived symptoms
Changes in symptoms will be assessed this outcome will be measured using PRO-CTCAE Derived Symptoms and other PROs. A scale Yes or No is utilized to describe whether the following symptoms have been experienced: Anxiety, constipation, decreased appetite, diarrhea, fatigue, general pain, insomnia, mouth sores, muscle pain, nausea, numbness and tingling, problems and concentration, rash, sad, shortness of breath, vomiting. The following scale: Rarely, occasionally, frequently or almost constantly will be used to measure anxiety and general pain. Severity of the following symptoms: Anxiety, fatigue, general pain and problems with concentration in a 7 day time period will be measured using the following scale: Mild, Moderate, Severe, Very Severe.
Weekly for 12 weeks
To quantify the change over time in PRO-CTCAE derived symptoms
Changes in symptoms will be assessed this outcome will be measured using PRO-CTCAE Derived Symptoms and other PROs. A scale Yes or No is utilized to describe whether the following symptoms have been experienced: Anxiety, constipation, decreased appetite, diarrhea, fatigue, general pain, insomnia, mouth sores, muscle pain, nausea, numbness and tingling, problems and concentration, rash, sad, shortness of breath, vomiting. The following scale: Rarely, occasionally, frequently or almost constantly will be used to measure anxiety and general pain. Severity of the following symptoms: Anxiety, fatigue, general pain and problems with concentration in a 7 day time period will be measured using the following scale: Mild, Moderate, Severe, Very Severe.
Month 1 following completion of chemotherapy
To quantify the change over time in PRO-CTCAE derived symptoms
Changes in symptoms will be assessed this outcome will be measured using PRO-CTCAE Derived Symptoms and other PROs. A scale Yes or No is utilized to describe whether the following symptoms have been experienced: Anxiety, constipation, decreased appetite, diarrhea, fatigue, general pain, insomnia, mouth sores, muscle pain, nausea, numbness and tingling, problems and concentration, rash, sad, shortness of breath, vomiting. The following scale: Rarely, occasionally, frequently or almost constantly will be used to measure anxiety and general pain. Severity of the following symptoms: Anxiety, fatigue, general pain and problems with concentration in a 7 day time period will be measured using the following scale: Mild, Moderate, Severe, Very Severe.
Month 3 following completion of chemotherapy
To quantify the change over time in PRO-CTCAE derived symptoms
Changes in symptoms will be assessed this outcome will be measured using PRO-CTCAE Derived Symptoms and other PROs. A scale Yes or No is utilized to describe whether the following symptoms have been experienced: Anxiety, constipation, decreased appetite, diarrhea, fatigue, general pain, insomnia, mouth sores, muscle pain, nausea, numbness and tingling, problems and concentration, rash, sad, shortness of breath, vomiting. The following scale: Rarely, occasionally, frequently or almost constantly will be used to measure anxiety and general pain. Severity of the following symptoms: Anxiety, fatigue, general pain and problems with concentration in a 7 day time period will be measured using the following scale: Mild, Moderate, Severe, Very Severe.
Month 6 following completion of chemotherapy
Criterios de elegibilidad

Criterios de edad
Adulto, Adulto mayor
Edad mínima
18 Years
Criterios de sexo
Mujer
  • Women with curative-intent breast cancer who plan to undergo at least 4 cycles of chemotherapy.
  • Age > 18 years
  • ECOG performance score < 3
  • English-speaking
  • with sufficient vision/hearing or family support
  • Coronary artery disease, if cleared by cardiologist
  • Subject must have smart phone, computer or tablet.
  • Willingness to be randomized

  • Medical or psychiatric conditions (beyond those related to breast cancer and its treatment) that would impair our ability to test study hypotheses (psychotic disorders, dementia, inability to give informed consent or follow instructions).
  • Patients with overt evidence of a psychiatric disorder.
  • Coronary artery disease, not cleared by cardiologist.
  • Contraindication to exercise.
  • Chronic fatigue syndrome.
Virtua Health, Inc. logoVirtua Health, Inc.
Carevive Systems, Inc. logoCarevive Systems, Inc.
Contactos centrales del ensayo
Contacto: Susan VanLoon, RN, CCRP, 8562477382, [email protected]
1 Sitios del ensayo en 1 países

New Jersey

Virtua Health, Voorhees Township, New Jersey, 08043, United States
Susan VanLoon, RN, CCRP, Contacto, 856-247-7382, [email protected]
Reclutando