Breast Cancer, Cancer Related Fatigue
Conditions
Keywords
Breast Cancer Survivorship, Home Based Exercise, Fatigue Management
Brief summary
This study evaluates the feasibility and preliminary effects of a home based exercise and activity program for individuals with cancer. Participants will engage in a structured intervention designed to support physical activity and symptom management. The study will assess changes in patient reported outcomes, functional measures, and overall adherence to the program. Findings will help determine whether this approach is practical and potentially beneficial for improving health related outcomes in this population.
Interventions
BEHAVIORALEXCAP Exercise Program
Home-based walking prescription with progressive 5% weekly step increase and resistance band training performed at least twice per week over 6 weeks.
BEHAVIORAL10-Hour Healthy Eating Timeframe (hEAT)
Participants will self-select and maintain a daily eating window of 10 hours or less for 6 weeks, with timing of first and last meals recorded daily.
Sponsors
University of Rochester
National Cancer Institute (NCI)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Must be aged 18 years or older * Must have a confirmed diagnosis of breast cancer (stage I-IIIC) * Must have completed adjuvant chemotherapy, surgery, and/or radiation for cancer at least 2 - 120 months prior to enrolling, * Must be prescribed adjuvant endocrine therapy, * Must have a baseline level of fatigue, as determined by reporting a score of 4 or higher on the Symptom Inventory * Must have a body mass index greater than or equal to 25 kg per meter squared * Must have the ability to ambulate independently * Must be willing and able to participate in home-based exercise and eating timeframe intervention * Must have the ability to read and understand the English language,
Exclusion criteria
* Must not have metastatic or recurrent breast cancer * Must not be currently receiving chemotherapy or radiation therapy * Must not have a medical condition that would preclude safe participation in intervention or study procedures * Must not be pregnant, or planning to become pregnant during the study period * Must not be in the active or maintenance stage of exercise behavior as assessed by the Exercise Stages of Change Short Form, * Must not have any condition that in the opinion of the investigator would interfere with participation or safety * Must not be currently using, or plan to initiate use of prescription or over-the-counter weight-loss medications
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants Meeting Pre-Specified Adherence Criteria | Baseline to Day 42 | Percentage of participants who meet all three adherence criteria during the 6-week intervention: Maintain a ≤10-hour eating timeframe on at least 50 percent of intervention days (21 of 42 days) Complete resistance band exercises at least 12 total sessions during the 6-week period Increase average weekly step count by at least 20 percent from baseline to Week 6 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in Brief Fatigue Inventory Total Score | Baseline to Day 42 | Mean difference in total BFI score from baseline (Day 0) to post-intervention (Day 42). Higher scores indicate greater fatigue. |
| Mean Change in Multidimensional Fatigue Symptom Inventory Total Score | Baseline to Day 42 | Mean difference in total MFSI score from baseline (Day 0) to post-intervention (Day 42). Higher scores indicate greater fatigue burden. |
| Mean Change in Body Mass Index | Baseline to Day 42 | Mean difference in BMI (kg/m²) measured at baseline and at Day 42. |
| Mean Change in 30-Second Bicep Curl Test Repetitions | Baseline to Day 42 | Mean difference in total number of completed bicep curl repetitions within 30 seconds from baseline to Day 42. |
| Mean Change in 30-Second Chair Stand Test Repetitions | Baseline to Day 42 | Mean difference in total number of completed chair stands within 30 seconds from baseline to Day 42. |
| Mean Change in Estimated Submaximal VO2 | Baseline to Day 42 | Mean difference in estimated VO2submax (mL/kg/min) obtained from treadmill testing at baseline and Day 42. |
Countries
United States
Contacts
CONTACTLindsey Mattick, PhD
PRINCIPAL_INVESTIGATORLindsey Mattick, PhD
University of Rochester
Outcome results
None listed