IA Trial Radar | ||
|---|---|---|
O estudo clínico NCT05704842 para Câncer de mama está recrutando. Consulte a visualização em cartões do Radar de Estudos Clínicos e as ferramentas de descoberta de IA para ver todos os detalhes. Ou pergunte qualquer coisa aqui. | ||
Um estudo corresponde aos critérios do filtro
Visualização em cartões
Evaluate Impact of Exercise Program on Fatigue in Breast Cancer During Chemotherapy
Os detalhes do estudo clínico estão disponíveis principalmente em inglês. No entanto, a IA Trial Radar pode ajudar! Basta clicar em 'Explicar o estudo' para visualizar e discutir as informações do estudo no idioma selecionado.
O estudo clínico NCT05704842 é um ensaio intervencionista para Câncer de mama. Seu status atual é: recrutando. O estudo começou em 22 de dezembro de 2022 e pretende incluir 40 participantes. Coordenado por Virtua Health, Inc. e deve ser concluído em 1 de junho de 2026. Essas informações foram atualizadas no ClinicalTrials.gov em 5 de abril de 2024.
Resumo
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.
Descrição detalhada
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:
- . To examine the feasibility of recruitment and retention of women undergoing treatment for breast cancer over the duration of the chemotherapy regimen.
- To examine the adherence to the exercise regime for those in the intervention group and compare the retention rates between treatment and control groups
- 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:
- To quantify the change over time in PRO-CTCAE derived symptoms and other PROs by computing means and SD.
- 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
Condições
Câncer de mamaOutros IDs do estudo
- IRB-2021-04
Número NCT
Data de início (real)
2022-12-22
Última atualização postada
2024-04-05
Data de conclusão (estimada)
2026-06-01
Inscrição (estimada)
40
Tipo de estudo
Intervencionista
FASE
N/A
Status
Recrutando
Propósito principal
Outro
Alocação do design
Randomizado
Modelo de intervenção
Fatorial
Cegamento (Mascaramento)
Nenhum (Estudo aberto)
Braços / Intervenções
| Grupo de participantes/Braço | Intervenção/Tratamento |
|---|---|
OutroExercise 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. | EXERCÍCIO Home-based exercise program including core exercises as follows: Core Stabilization, core extension, leg extensions, squats with and without weights, shoulder and arm exercises. |
Nenhuma intervençãoControl 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 |
Desfecho primário
Desfecho secundário
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
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 |
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
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 |
Critérios de elegibilidade
Idades elegíveis
Adulto, Adulto mais velho
Idade mínima
18 Years
Sexos elegíveis
Feminino
- 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.Carevive Systems, Inc.Contato central do estudo
Contato: Susan VanLoon, RN, CCRP, 8562477382, [email protected]
1 Locais do estudo em 1 países
New Jersey
Virtua Health, Voorhees Township, New Jersey, 08043, United States
Susan VanLoon, RN, CCRP, Contato, 856-247-7382, [email protected]
Recrutando