Feasibility of 'Exercise for CAncer Patients and Healthy EAting Timeframes' . (EXCAP-hEAT)

Feasibility of 'Exercise for CAncer Patients and Healthy EAting Timeframes' (EXCAP-hEAT) Among Breast Cancer Survivors Receiving Adjuvant Endocrine Therapy.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Breast Cancer; Cancer Related Fatigue
• Intervention / Treatment: Behavioral: EXCAP Exercise Program; Behavioral: 10-Hour Healthy Eating Timeframe (hEAT)

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lindsey Mattick, PhD; Phone Number: 5852740473; Email: Lindsey_Mattick@urmc.rochester.edu

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14642
      • Wilmot Cancer Institute
      • Contact: Lindsey Mattick, PhD MS; Phone Number: 5852740473; Email: Lindsey_Mattick@urmc.rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EXCAP-hEAT Intervention; Participants will complete a 6-week home-based combined lifestyle intervention consisting of a structured exercise program (EXCAP) and a self-selected 10-hour daily healthy eating timeframe. The intervention includes aerobic walking, progressive resistance band training, and daily tracking of eating timeframes and physical activity.	Behavioral: EXCAP 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.; Behavioral: 10-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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Baseline to Day 42

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline to Day 42
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.	Baseline to Day 42
Mean Change in Body Mass Index	Mean difference in BMI (kg/m²) measured at baseline and at Day 42.	Baseline to Day 42
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.	Baseline to Day 42
Mean Change in 30-Second Chair Stand Test Repetitions	Mean difference in total number of completed chair stands within 30 seconds from baseline to Day 42.	Baseline to Day 42
Mean Change in Estimated Submaximal VO2	Mean difference in estimated VO2submax (mL/kg/min) obtained from treadmill testing at baseline and Day 42.	Baseline to Day 42

Collaborators and Investigators

• Sponsor: University of Rochester
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Lindsey Mattick, PhD, University of Rochester

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2028

Study Registration Dates

• First Submitted: April 7, 2026
• First Submitted That Met QC Criteria: April 7, 2026
• First Posted (Actual): April 14, 2026

Study Record Updates

• Last Update Posted (Actual): April 14, 2026
• Last Update Submitted That Met QC Criteria: April 7, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Breast Cancer Survivorship; Home Based Exercise; Fatigue Management
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms
• Other Study ID Numbers: STUDY00010857

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No