A Flexible Individualized ExeRcise Programme for Cancer Patients During ChEmotherapy

Not Applicable

Not yet recruiting

• Conditions: Cancer
• Interventions: Behavioral: Exercise; Behavioral: Health Behaviour Change (Pedometer)

• Registration Number: NCT06280885
• Lead Sponsor: University of Dublin, Trinity College

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.

Study Timeline

• Study First Submitted: 2023-12-06
• Status Verified: 2024-02
• Study First Submitted QC: 2024-02-19
• Last Update Submitted: 2024-02-19
• Study First Posted: 2024-02-28
• Last Update Posted: 2024-02-28
• Study Start: 2024-03-01
• Primary Completion: 2025-09-01
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

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.

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Exclusion Criteria

• Advanced/metastatic disease.
• Scheduled to receive concurrent chemoradiotherapy.
• Scheduled to receive high-dose chemotherapy during hospital admission.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FIERCE Programme	Exercise	The FIERCE programme will consist of an aerobic and resistance exercise program delivered for the duration of chemotherapy. Exercise will be prescribed with the aim of achieving an overall exercise volume over the course of a chemotherapy cycle. The total volume of exercise prescribed in each cycle will be targeted towards achieving the exercise guidelines for cancer survivors which recommends 90 minutes of aerobic activity per week, in addition to resistance exercise at least two times per week. Exercise intensity will be autoregulated by participants based on how they are feeling on a given day. Participants will be given a choice of exercising at low, moderate, or higher intensity based on how BORG rating of perceived exertion (RPE) scale. Weekly check ins will be made to each participant over the phone by an exercise physiologist for goal setting. Participants will also be given a pedometer to monitor daily physical activity levels.
Pedometer programme	Health Behaviour Change (Pedometer)	Participants randomized to the pedometer programme will receive individualised advice about exercising during chemotherapy and will also receive a pedometer to encourage daily activity. Participant in both groups will receive a personal exercise consultation to identify their individual needs and understand their exercise preferences.
FIERCE Programme	Health Behaviour Change (Pedometer)	The FIERCE programme will consist of an aerobic and resistance exercise program delivered for the duration of chemotherapy. Exercise will be prescribed with the aim of achieving an overall exercise volume over the course of a chemotherapy cycle. The total volume of exercise prescribed in each cycle will be targeted towards achieving the exercise guidelines for cancer survivors which recommends 90 minutes of aerobic activity per week, in addition to resistance exercise at least two times per week. Exercise intensity will be autoregulated by participants based on how they are feeling on a given day. Participants will be given a choice of exercising at low, moderate, or higher intensity based on how BORG rating of perceived exertion (RPE) scale. Weekly check ins will be made to each participant over the phone by an exercise physiologist for goal setting. Participants will also be given a pedometer to monitor daily physical activity levels.

Primary Outcome Measures

Name	Time	Method
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: 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: 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: Reason for drop0out	Through study completion, on average 6 months	Reasons for dropout will be recorded descriptively

Secondary Outcome Measures

Name	Time	Method
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.
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)).
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).
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.
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.
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.

Trial Locations

Locations (1)

St James's Hospital; 🇮🇪 Dublin, Ireland