Cancer
Conditions
Brief 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.
Interventions
BEHAVIORALExercise
Participants will be randomised to either the FIERCE exercise programme involving supervised exercise prescription
BEHAVIORALHealth Behaviour Change (Pedometer)
Participants in both arms will be provided with a pedometer as a health behaviour change intervention
Sponsors
University of Dublin, Trinity College
St. James's Hospital, Ireland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Masking description
Not indicated for this feasibility study.
Intervention model description
Feasibility randomised controlled trial using a 2:1 randomisation
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Aged \>18. * Histological confirmed diagnosis of stage I to IIIc breast, ovarian 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility: Recruitment rates | At enrolement | Recruitment rates will be calculated as the percentage of eligible participants who agreed to take part in the study. Recruitment rates will be calculated for each recruitment timepoint to determine which timepoint yields optimal recruitment. Reasons for declining recruitment will also be recorded. |
| Feasibility: Adherence rates | Through study completion, on average 6 months | Exercise adherence will be used to measure the degree to which the participants performed the exercise at the desired intensity and time. After each exercise session, participants will be asked to rate their perceived exertion that they actually achieved during the exercise class. This RPE will be compared to the prespecified intensity that was chosen by the participant on the BORG scale at the beginning of the class to determine adherence to the intensity of the exercise session. Adherence to exercise time will be calculated by recording the total number of minutes spent exercising in each class compared to the total duration of the class. |
| Feasibility: Attendance rates | Through study completion, on average 6 months | Exercise attendance will be calculated as the total number of exercise classes attended, either in-person or online, regardless of how much exercise was performed. |
| Feasibility: Retention Rates | Through study completion, on average 6 months | Retention rates will be calculated as the number of participants who remained in the study at the end of the intervention as a proportion of the total number of participants recruited. |
| Feasibility: Reason for drop0out | Through study completion, on average 6 months | Reasons for dropout will be recorded descriptively |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cardiorespiratory Fitness | Pre and post intervention (on average 6 months) | Cardiorespiratory fitness will be estimated using the submaximal Astrand-Rhyming Cycle Ergometer Test (ARCET). The test will be performed on a cycle ergometer and will include breath-by-breath analysis using COSMED QUARK equipment. |
| Muscular Strength | Pre and Post intervention, on average 6 months | Leg Strength Leg strength will be measured using a 1 repetition max (1RM) leg press test. Participants will complete a warm-up of 6 repetitions at approximately 60% 1RM followed by 3 repetitions at 80% 1RM. Following successful completion of the warm-up repetitions, participants will perform a maximum effort to determine their 1RM. Participants will be given a maximum of 5 attempts to determine their 1RM with a 2-minute rest between each attempt. Hand Grip Strength Hand grip strength (HGS) will be measured using a hand-held dynamometer. Participants will perform the test in a seated position, with their elbow at 90 degrees. Participants will be instructed to squeeze on the handle using maximum effort for 3 seconds. Three attempts will be made on each hand with a 1-minute rest between attempts. The highest value will be recorded. |
| Body Mass Index | Pre and Post intervention, on average 6 months | Weight (kilogrammes (kg)) and height (centimetres (cm)) will be recorded by standard methods using a calibrated scales and stadiometer. Body mass index (BMI) will be calculated as weight (kg)/ height (metres (m2)). |
| Mid-arm circumference | Pre and Post intervention, on average 6 months | Mid-arm muscle circumference will be measured in centimetres at the halfway point between the olecranon process of the ulna and the acromion process of the scapula. |
| Waist Circumference | Pre and Post intervention, on average 6 months | Waist circumference will be measured in centimetres at the mid-point between the iliac crest and the 12th rib following gentle expiration. Circumferential measurements will be taken in duplicate and averaged for data entry. |
| Bioimpedance Analysis | Pre and Post intervention, on average 6 months | Bioimpedance analysis (BIA) will be used to determine body composition and will be performed using the SECA mBCA 515 (Seca, Hamburg, Germany). Measures recorded will include; fat mass, fat free mass, and skeletal muscle mass (all measured in kg). |
| Health Related Quality of Life | Pre and Post intervention, on average 6 months | Health-related quality of life will be determined by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30 version 3.0). This validated instrument assessed quality of life in functional, symptom and global domains. Scores for each question were calculated according to the EORTC QLQ-C30 manual and linearly transformed into a 0-100 scale A high score for a functional scale indicates a high level of functioning. A high score for a symptom scale/single item represents a high symptom burden. |
| Fatigue | Pre and Post intervention, on average 6 months | Fatigue will be measured using the Cancer Fatigue Scale (CFS). The CFS is a 15-item scale comprising of 3 subscales, physical (maximum score 28), affective (maximum score 16), and cognitive (maximum score 16), with a total score range from 0-60. Higher scores reveal more severe fatigue. |
Countries
Ireland
Outcome results
None listed