Feasibility of 'Exercise for CAncer Patients and Healthy EAting Timeframes' .

NCT07529353 | Not Yet Recruiting DMC

• 1 other identifier: STUDY00010857
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Cancer Related Fatigue

Keywords

Breast Cancer Survivorship; Home Based Exercise; Fatigue Management

Outcome Measures

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

  Baseline to Day 42

Secondary Outcomes (6)

• Mean Change in Brief Fatigue Inventory Total Score

  Baseline to Day 42

• Mean Change in Multidimensional Fatigue Symptom Inventory Total Score

  Baseline to Day 42

• Mean Change in Body Mass Index

  Baseline to Day 42

• Mean Change in 30-Second Bicep Curl Test Repetitions

  Baseline to Day 42

• Mean Change in 30-Second Chair Stand Test Repetitions

  Baseline to Day 42

Study Arms (1)

EXCAP-hEAT Intervention

EXPERIMENTAL

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; Behavioral: 10-Hour Healthy Eating Timeframe (hEAT)

Interventions

EXCAP Exercise Program BEHAVIORAL

Home-based walking prescription with progressive 5% weekly step increase and resistance band training performed at least twice per week over 6 weeks.

EXCAP-hEAT Intervention

10-Hour Healthy Eating Timeframe (hEAT) BEHAVIORAL

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.

EXCAP-hEAT Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Rochester: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Wilmot Cancer Institute

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Lindsey Mattick, PhD

  University of Rochester

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lindsey Mattick, PhD

CONTACT

5852740473; Lindsey_Mattick@urmc.rochester.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor - Department of Surgery

Study Record Dates

• First Submitted: April 7, 2026
• First Posted: April 14, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2028
• Last Updated: April 14, 2026

Record last verified: 2026-04

Locations

US (1)