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Trial Title:
A Flexible Individualized ExeRcise Programme for Cancer Patients During ChEmotherapy
NCT ID:
NCT06280885
Condition:
Cancer
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Feasibility randomised controlled trial using a 2:1 randomisation
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Masking description:
Not indicated for this feasibility study.
Intervention:
Intervention type:
Behavioral
Intervention name:
Exercise
Description:
Participants will be randomised to either the FIERCE exercise programme involving
supervised exercise prescription
Arm group label:
FIERCE Programme
Intervention type:
Behavioral
Intervention name:
Health Behaviour Change (Pedometer)
Description:
Participants in both arms will be provided with a pedometer as a health behaviour change
intervention
Arm group label:
FIERCE Programme
Arm group label:
Pedometer programme
Summary:
The primary aim of this study is to measure the feasibility of delivering a co-designed
exercise programme for patients with cancer receiving chemotherapy treatment.
Detailed description:
Exercise has been shown to play an important role in reducing many of the side effects
associated with chemotherapy treatment. Exercise can help to improve symptoms of fatigue,
nausea, muscle weakness, and pain, which in turn can help to improve patients overall
quality of life and wellbeing. In addition to this, exercising during chemotherapy can
also help to maintain physical fitness and preserve muscle mass, which has been shown to
significantly reduce treatment toxicities. Despite these benefits of exercise, performing
regular physical activity during chemotherapy poses significant challenges. Patients are
faced with a number of physical and logistical barriers during chemotherapy which makes
it difficult to engage in regular exercise. In addition to this, exercise programs that
are being designed lack flexibility and individualization, and don't account for the
unpredictable nature of chemotherapy treatment. It is, therefore, no surprise that
patients struggle to meet the exercise recommendations during chemotherapy, and
highlights the need for careful consideration when prescribing exercise during this time.
In preparation for this study, the research team held a number of workshops which
included a mixture of patients and healthcare professionals with the aim of co-designing
an exercise intervention for patients during chemotherapy. Including public and patient
involvement (PPI) in the design process will help to ensure that the exercise program
that is developed is pragmatic and, most importantly, patient-centred.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Aged >18.
- Histological confirmed diagnosis of stage I to IIIc breast or colorectal cancer.
- Scheduled to receive chemotherapy ± immunotherapy with curative intent.
- Medical clearance from oncologist to partake in regular exercise in accordance with
American College of Sports Medicine (ACSM) preparticipation screening algorithm.
- Ability to provide written informed consent.
Exclusion Criteria:
- Advanced/metastatic disease.
- Scheduled to receive concurrent chemoradiotherapy.
- Scheduled to receive high-dose chemotherapy during hospital admission.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
St James's Hospital
Address:
City:
Dublin
Zip:
8
Country:
Ireland
Start date:
March 1, 2024
Completion date:
March 31, 2026
Lead sponsor:
Agency:
University of Dublin, Trinity College
Agency class:
Other
Collaborator:
Agency:
St. James's Hospital, Ireland
Agency class:
Other
Source:
University of Dublin, Trinity College
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06280885
