Breast Cancer
Conditions
Brief summary
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.
Detailed description
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
Interventions
BEHAVIORALExercise
Home-based exercise program including core exercises as follows: Core Stabilization, core extension, leg extensions, squats with and without weights, shoulder and arm exercises.
Sponsors
Carevive Systems, Inc.
Virtua Health, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Determine the feasibility of a specific home-based exercise program in reducing cancer-related fatigue. | Baseline | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To quantify the change over time in PRO-CTCAE derived symptoms | Baseline | 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. |
Countries
United States
Contacts
Primary ContactSusan VanLoon, RN, CCRP
Outcome results
None listed