PACES: Physical exercise during Adjuvant Chemotherapy Effectiveness Study.

Completed

• Conditions: breast cancer, colon cancer, borstkanker, darmkanker

• Registration Number: NL-OMON20755
• Lead Sponsor: etherlands Cancer Institute - Antoni van Leeuwenhoek Hospital (NKI AVL)

Brief Summary

/A

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 360

Inclusion Criteria

Patients with histologically confirmed primary breast or primary colon cancer who are scheduled to undergo adjuvant chemotherapy with curative intent.

Exclusion Criteria

Patients with comorbid conditions that would contraindicate participation in a physical activity/exercise program.
This includes patients with serious orthopedic conditions that would hamper functional recovery, and patients with serious cardiovascular or cardiopulmonary conditions (or risks) who would not be able to train at the intensity level required by the programs. Patients suffering from malnutrition as evidenced by a BMI < 18 kg/m2, unintended weight loss of more than 5% per month, or more than 10% unintended weight loss during the previous 6 month period will be considered poor candidates for physical condition training and thus will not be eligible for participation. Patients judged to have serious psychiatric or cognitive problems that would preclude them from program participation will be excluded from the study. For assessment purposes, study participants will need to have basic fluency in the Dutch language. Patients participating in concurrent studies or rehabilitation programs containing elements of physical activity or exercise will also be considered ineligible for the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Cardiorespiratory fitness;<br /><br>2. Muscle strength;<br /><br>3. Self-reported fatigue.

Secondary Outcome Measures

Name	Time	Method
1. Mood disturbance;<br /><br>2. Self-reported physical activity level;<br /><br>3. Functioning in daily life;<br /><br>4. Health-related quality of life;<br /><br>5. Quality of sleep;<br /><br>6. Measured physical activity level;<br /><br>7. Chemotherapy completion rates;<br /><br>8. Complaince;<br /><br>9. Statisfaction with intervention;<br />