NCT01030887

PEACH Trial: Prescribed Exercise After Chemotherapy

Individually Prescribed Exercise Versus Usual Care in a Heterogeneous Cancer Survivor Population: A Pragmatic Randomized Controlled Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: University of Dublin, Trinity College · Academic / Other
• Sex: All
• Age: 21 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Many cancer survivors suffer symptoms such as fatigue and dyspnea which may persist for years or months after their chemotherapy has finished. Despite the known benefits of exercise and its potential to address many of the symptoms after cancer, the type of practical exercise programme which best suits this population is not known. Many exercise programmes performed in cancer survivors take place over many weeks or months and include people with specific types of cancer. Such programmes may therefore not be suitable for the majority of cancer survivors and would pose serious practical difficulties with high drop-out rates and expensive resource consumption if they were extended into clinical practice. We propose to run an 8-week exercise intervention in a mixed cancer population. Hypothesis: A brief, individually tailored 8-week intervention will increase fitness and improve other physical symptoms in a mixed cancer survivor population after chemotherapy.

Detailed description

Background: Many cancer survivors suffer a range of physical and psychological symptoms with may persist for years or months after treatment finishes. Despite the known benefits of exercise and its potential to address many of these adverse effects of treatment, the role of exercise as well as its optimum duration, frequency, and intensity in this population has yet to be fully elucidated. Many cancer rehabilitation programmes presented in the literature are very long, have tight eligibility criteria and are not likely to be practical in the majority of cancer survivors. We plan to investigate a novel brief 8-week intervention which aims to increase physical fitness, and address other physical symptoms in a heterogeneous cancer survivor population. Methods/design: Approximately 60 cancer survivors 2-6 months after completion of chemotherapy, usually adjuvant, with curative intent will be recruited through oncology clinics in a single institution and randomised to usual care or an exercise intervention. The exercise intervention consists of two specifically tailored, supervised, moderate intensity aerobic exercise sessions per week for 8 weeks. All participants will be assessed at baseline (0 weeks), post intervention (8 weeks), and at 3-month follow-up. The primary outcome measure is fitness, and secondary patient-related outcome measures include fatigue, quality of life, and morphological outcomes. A further secondary outcome is process evaluation including adherence to and compliance with the exercise program. Discussion: This study will provide valuable information about the physical outcomes of this 8-week supervised aerobic programme. Additional process information and economic evaluation will inform the feasibility of implementing this program in a heterogeneous population after chemotherapy treatment with curative intent.

Conditions

• Cancer

Interventions

Type	Name	Description
BEHAVIORAL	Exercise programme	Moderate intensity exercise

Timeline

• Start date: 2010-01-01
• Primary completion: 2011-08-01
• Completion: 2011-08-01
• First posted: 2009-12-14
• Last updated: 2011-08-15

Locations

1 site across 1 country: Ireland