Feasibility of 'Exercise for CAncer Patients and Healthy EAting Timeframes' .
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Rochester
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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,
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
EXCAP Exercise Program
BehavioralHome-based walking prescription with progressive 5% weekly step increase and resistance band training performed at least twice per week over 6 weeks.
10-Hour Healthy Eating Timeframe (hEAT)
BehavioralParticipants 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.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: EXCAP-hEAT InterventionExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Proportion of Participants Meeting Pre-Specified Adherence Criteria
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
Time frame
Baseline to Day 42Secondary outcomes
1
Mean Change in Brief Fatigue Inventory Total Score
Mean difference in total BFI score from baseline (Day 0) to post-intervention (Day 42). Higher scores indicate greater fatigue.
Time frame
Baseline to Day 422
Mean Change in Multidimensional Fatigue Symptom Inventory Total Score
Mean difference in total MFSI score from baseline (Day 0) to post-intervention (Day 42). Higher scores indicate greater fatigue burden.
Time frame
Baseline to Day 423
Mean Change in Body Mass Index
Mean difference in BMI (kg/m²) measured at baseline and at Day 42.
Time frame
Baseline to Day 424
Mean Change in 30-Second Bicep Curl Test Repetitions
Mean difference in total number of completed bicep curl repetitions within 30 seconds from baseline to Day 42.
Time frame
Baseline to Day 42Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Rochester
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov
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