Clinical trial · Interventional
Feasibility of 'Exercise for CAncer Patients and Healthy EAting Timeframes' .
Feasibility of 'Exercise for CAncer Patients and Healthy EAting Timeframes' (EXCAP-hEAT) Among Breast Cancer Survivors Receiving Adjuvant Endocrine Therapy.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Cancer Related Fatigue | Breast Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 10-Hour Healthy Eating Timeframe (hEAT) | Behavioral | — | UNRESOLVED |
| EXCAP Exercise Program | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- EXCAP-hEAT Intervention
- description
- 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.
- interventionNames
- Behavioral: EXCAP Exercise Program
- Behavioral: 10-Hour Healthy Eating Timeframe (hEAT)
Primary outcomes (1)
- measure
- Proportion of Participants Meeting Pre-Specified Adherence Criteria
- timeFrame
- Baseline to Day 42
- description
- 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 outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available