Cancer Related Fatigue / EXCAP Exercise Program / Breast Cancer · Interventional Study

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

ClinicalTrials.gov · August 17, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a registered feasibility study of a home-based exercise and healthy eating intervention for cancer patients with cancer-related fatigue. No results have been posted in the registry; the study is designed to evaluate adherence, patient-reported outcomes, and functional measures over 42 days in an estimated 20 participants to determine whether the approach is practical and warrants larger evaluation.

What was studied

Interventional, Single Group, Open label, Supportive Care purpose. Breast Cancer, Cancer Related Fatigue; age from 18 Years. Intervention: EXCAP-hEAT Intervention. n = 20. 1 site: United States.

Key findings

Safety

Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

This is a feasibility study registration with no posted results; it is designed to assess enrollment, adherence, and preliminary signals in a small planned cohort of 20 cancer patients.

Study design

As stated by the source record.

MethodsPrimary outcome measure: Proportion of Participants Meeting Pre-Specified Adherence Criteria (assessed at Baseline to Day 42)

DesignInterventional, Single Group, Open label, Supportive Care purpose

PopulationBreast Cancer, Cancer Related Fatigue; age from 18 Years

Sample size20

InterventionEXCAP-hEAT Intervention

Setting1 site: United States

Reported figures

Quoted from the source exactly as published.

Planned enrollment20

Primary outcome measureProportion of Participants Meeting Pre-Specified Adherence Criteria, Baseline to Day 42

Follow-up duration42 days

Caveats

This is a registry record; no results are posted and no outcomes have been reported.
No control or comparator group is specified in the registration.
Study has not yet begun recruitment (status: NOT_YET_RECRUITING).
Small planned sample (n=20) limits power for efficacy conclusions when results are available.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

moderate

Interventional feasibility study with behavioral interventions; no control arm specified.

Directness

moderate

Addresses cancer-related fatigue and physical activity in cancer patients; uses patient-reported outcomes and functional measures.

Consistency

insufficient

No results posted; cannot assess consistency with prior work.

Risk of bias

insufficient

Feasibility study registration; no design details on blinding, allocation concealment, or analysis plan disclosed.

Sample adequacy

limited

Planned enrollment 20 participants; appropriate for feasibility but underpowered for efficacy claims.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT07529353). This is a study registration, not published results. Lead sponsor: University of Rochester. Recruitment status: NOT_YET_RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 20 participants (ESTIMATED). Conditions: Breast Cancer, Cancer Related Fatigue. Interventions: BEHAVIORAL: EXCAP Exercise Program; BEHAVIORAL: 10-Hour Healthy Eating Timeframe (hEAT). Primary outcome measures: Proportion of Participants Meeting Pre-Specified Adherence Criteria , Baseline to Day 42. 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.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.